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36 Aortic Stenosis Trials near Miami, FL
Power is an online platform that helps thousands of Aortic Stenosis patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
SAPIEN 3 THV for Aortic Stenosis
Miami Beach, FloridaTo establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:All
Sex:All
1000 Participants Needed
TAVI vs SAVR for Aortic Stenosis
Coral Gables, FloridaThe purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.
Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:All
Sex:All
1746 Participants Needed
Aortic Valve Replacement for Aortic Stenosis
Miami Beach, FloridaThis trial compares two methods of heart valve replacement in patients with severe narrowing of the heart valve. It aims to see if one method is better at improving blood flow and reducing symptoms without needing major surgery.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
1103 Participants Needed
PCI vs Medical Management for Aortic Stenosis
Miami, FloridaPatients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management.
The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance.
The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure.
The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR.
Complete Revascularization:
Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR.
Vs. Medical Therapy Alone:
No further revascularization of coronary artery lesions.
All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:All
Sex:All
Key Eligibility Criteria
Disqualifiers:Prior CABG, Severe Mitral Regurgitation, Severe LV Dysfunction, Others
4000 Participants Needed
TAVR vs SAVR for Aortic Valve Stenosis
Miami, FloridaThe study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.
The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:All
Sex:All
2223 Participants Needed
TAVR for Heart Failure
Miami, FloridaThe objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
178 Participants Needed
Pelacarsen for Aortic Stenosis
Miami Lakes, FloridaThe purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Aortic Stenosis, Uncontrolled Hypertension, Malignancy, Others
502 Participants Needed
Valve Function Assessment After TAVR for Aortic Valve Stenosis
Hollywood, FloridaThis trial tests a new way to evaluate heart valve replacements in patients with small failing valves. It uses a minimally invasive procedure to place a new valve inside the old one and compares two methods of checking how well the new valve works.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Stentless Valves, Trifecta, Hancock II, Others
310 Participants Needed
Evogliptin for Aortic Stenosis
Miami, FloridaThis is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks . the 3 arms are: placebo, DA-1229 5mg GroupDA-1229 10 mg Group.
The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:35+
Sex:All
867 Participants Needed
Inclisiran for Hypercholesterolemia
Boca Raton, FloridaThis is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 11
Sex:All
Key Eligibility Criteria
Disqualifiers:Secondary Hypercholesterolemia, HoFH, Active Liver Disease, Others
Must Be Taking:Statins, Ezetimibe
51 Participants Needed
TAVR Valves for Aortic Valve Stenosis
Delray Beach, FloridaOpen-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:All
Sex:All
150 Participants Needed
Portico Valve for Aortic Stenosis
Delray Beach, FloridaThis trial is testing a new heart valve replacement device for patients with severe heart valve issues who are too high-risk for traditional surgery. The device is inserted through a blood vessel, making the procedure less invasive.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21+
Sex:All
1242 Participants Needed
Siegel TAVR for Aortic Stenosis
Naples, FloridaThe Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Sex:All
Key Eligibility Criteria
Disqualifiers:Prosthetic Heart Valve, Severe Dementia, Others
Must Not Be Taking:Aspirin, Heparin, Ticlopidine, Others
15 Participants Needed
SAPIEN X4 THV for Aortic Stenosis
North Naples, FloridaThis trial is testing a new heart valve that can be inserted without surgery in patients with severe heart valve narrowing. The new valve helps improve blood flow by replacing the damaged one through a minimally invasive procedure.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:All
Sex:All
915 Participants Needed
SAPIEN X4 THV for Failing Aortic Valves
Naples, FloridaThis trial tests a new artificial heart valve that can be inserted without open-heart surgery. It focuses on high-risk patients with failing aortic valves. The valve is placed using a thin tube, making the procedure safer for these patients. This new method offers a less invasive alternative to conventional surgery.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:All
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Mitral Regurgitation, Renal Insufficiency, Stroke, Others
200 Participants Needed
TAVR for Aortic Stenosis
Sarasota, FloridaThis trial tests advanced heart valves that can be inserted without open-heart surgery in patients with a narrowed and stiff aortic valve due to calcium buildup. The new valve is placed through a small cut and guided to the heart, where it replaces the damaged valve. This minimally invasive procedure has recently become the only lifesaving solution for patients who cannot tolerate standard surgical valve replacement.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65+
Sex:All
Key Eligibility Criteria
Disqualifiers:Aortic Regurgitation, LVEF < 20%, Others
2250 Participants Needed
TAVR with CENTERA THV for Aortic Stenosis
Sarasota, FloridaThis study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:All
Sex:All
101 Participants Needed
ACURATE TAVR System for Aortic Stenosis
Orlando, FloridaTo evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:All
Sex:All
1948 Participants Needed
TAVR for Aortic Stenosis
Orlando, FloridaObtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65+
Sex:All
Key Eligibility Criteria
Disqualifiers:Age < 65, LVEF ≤ 20%, Others
650 Participants Needed
Edwards Bioprosthetic Heart Valves for Heart Valve Disease
Orlando, FloridaThe objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
777 Participants Needed
TAVR for Aortic Stenosis
Clearwater, FloridaThe purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:19+
Sex:All
1074 Participants Needed
JenaValve Trilogy System for Aortic Regurgitation
Clearwater, FloridaThis trial examines using a new heart valve replacement procedure to treat patients with severe Aortic Regurgitation. The procedure replaces the faulty heart valve to improve blood flow and reduce symptoms like fatigue and shortness of breath. The new valve is designed to be self-expanding and has a specific mechanism for secure placement.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
180 Participants Needed
Aortic Valve Replacement for Aortic Stenosis
Gainesville, FloridaTo evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
1312 Participants Needed
TAVR for Aortic Stenosis
Gainesville, FloridaThis study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:65+
Sex:All
901 Participants Needed
Avalus Ultra Valve for Aortic Valve Disease
Gainesville, FloridaThe purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Prosthetic Valve, Systemic Infection, Renal Failure, Pregnancy, Others
150 Participants Needed
Shared Decision Making for Aortic Stenosis
Atlanta, GeorgiaThe goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are:
* Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
* Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:65 - 85
Sex:All
1300 Participants Needed
Aortic Valve-in-Valve for Aortic Stenosis
Atlanta, GeorgiaThis study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:All
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Regurgitation, Myocardial Infarction, Stroke, Others
125 Participants Needed
SESAME Procedure for Hypertrophic Cardiomyopathy
Atlanta, GeorgiaBackground:
Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO.
Objective:
To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME).
Eligibility:
Adults aged 21 years with LVOTO.
Design:
Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life.
Participants will stay in the hospital 2 to 6 days for the SESAME procedure.
They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart.
Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum.
Participants will have 3 follow-up visits within 1 year....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnant, Hemodynamic Instability, Others
30 Participants Needed
SAPIEN 3 Valve for Pulmonary Valve Dysfunction
Atlanta, GeorgiaThis trial tests a special heart valve that can be inserted without open-heart surgery. It targets patients with faulty heart valves in the pulmonic position. The new valve is delivered through a tube and helps the heart pump blood properly. The Direct Flow Medical valve has been developed with several important revisions to improve the efficacy and safety of the procedure.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:All
Sex:All
Key Eligibility Criteria
Disqualifiers:Infection, Endocarditis, Blood Disorders, Others
Must Not Be Taking:Antibiotics, Antiplatelets
108 Participants Needed
New Aortic Heart Valves for Aortic Stenosis
Asheville, North CarolinaThis trial is testing a new heart valve that can be inserted without open-heart surgery. It targets high-risk patients with severe aortic stenosis. The valve is put in through a small cut and helps the heart pump blood more effectively. This procedure offers an alternative to more invasive surgeries.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 100
Sex:All
333 Participants Needed
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Frequently Asked Questions
How much do Aortic Stenosis clinical trials in Miami, FL pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Aortic Stenosis clinical trials in Miami, FL work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Aortic Stenosis trials in Miami, FL 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Miami, FL for Aortic Stenosis is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Miami, FL several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Aortic Stenosis medical study in Miami, FL ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Aortic Stenosis clinical trials in Miami, FL ?
Most recently, we added Inclisiran for Hypercholesterolemia, Siegel TAVR for Aortic Stenosis and SESAME Procedure for Hypertrophic Cardiomyopathy to the Power online platform.