Transcatheter Shunt System for Heart Failure (ALT-FLOW II Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Edwards Lifesciences
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, it requires that you stay on guideline-directed medical therapy (GDMT) for heart failure for more than 30 days before screening and maintain it without change for 6 months.
Is the Edwards APTURE Transcatheter Shunt System a promising treatment for heart failure?The Edwards APTURE Transcatheter Shunt System is a promising treatment because similar Edwards transcatheter systems have shown significant improvements in heart valve treatments, leading to good clinical outcomes. These systems have been effective in treating heart conditions with less invasive procedures, which can be safer for patients at high surgical risk.236910
What safety data exists for the Transcatheter Shunt System for Heart Failure?The provided research does not contain specific safety data for the Transcatheter Shunt System for Heart Failure or its alternative names. The studies focus on adverse event reporting in thoracic surgery, endovascular treatment of aneurysms, pediatric cardiac catheterization, and adverse outcomes in congenital cardiac catheterization, but none directly address the safety of the Transcatheter Shunt System.17111213
What data supports the idea that Transcatheter Shunt System for Heart Failure is an effective treatment?The available research does not provide specific data on the effectiveness of the Transcatheter Shunt System for Heart Failure. Instead, it focuses on other transcatheter heart valve systems, such as the Edwards SAPIEN valve, which have shown positive outcomes in treating aortic stenosis, a different heart condition. These studies highlight improvements in survival, quality of life, and reduced complications for patients using these systems. However, this information does not directly support the effectiveness of the Transcatheter Shunt System for Heart Failure.458910
Eligibility Criteria
This trial is for adults with heart failure who have been on stable heart medication for over a month, experienced at least one hospitalization due to heart failure in the past year, and show specific signs of lung congestion during exercise. They must not have severe kidney issues, recent strokes or infections, certain types of valve disease, very poor walking ability or extremely severe heart failure.Inclusion Criteria
My heart's pumping ability is reduced but not severely, and I have moderate to severe difficulty with physical activity.
I have heart failure that causes me symptoms.
I have been hospitalized for heart failure or have high BNP/NT-proBNP levels.
My heart test shows high lung pressure during exercise.
Exclusion Criteria
I have severe heart failure and cannot move around easily.
I have not had a stroke, TIA, DVT, or pulmonary embolus in the last 6 months.
My heart's right side is not working well, or I have signs of liver issues due to heart problems, or my BMI is 45 or more.
My kidney function is low, shown by high creatinine or low eGFR, or I am on dialysis.
I have moderate to severe heart valve disease.
I can walk less than 50 meters or more than 450 meters in six minutes.
Treatment Details
The ALT-FLOW II Trial is testing the Edwards APTURE transcatheter shunt system against a sham procedure (a fake operation that seems real) to see if it helps patients with heart failure. Participants are randomly chosen to receive either the actual device implantation or a pretend procedure without receiving the device.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: APTURE shunt + medical therapyExperimental Treatment1 Intervention
Group II: Sham + medical therapyPlacebo Group1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California IrvineIrvine, CA
University of California San DiegoLa Jolla, CA
University of California San FranciscoSan Francisco, CA
Medical Center of the RockiesLoveland, CO
More Trial Locations
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
References
Patients' reaction to the disclosure of rare dreaded adverse events. [2021]Physicians must frequently inform their patients of the risks of rare, but serious, adverse events (AEs).
First successful trans-catheter aortic valve implantation through ascending aorta using Edwards SAPIEN THV system. [2016]Trans-catheter aortic valve implantation is rapidly becoming an established modality of treatment for patients with critical aortic stenosis who are high risk for conventional aortic valve replacement. This approach also has its limitations; however, with growing experience and improvements in the delivery system, it may be possible to overcome these limitations. We describe a case where conventional trans-catheter approaches, that is, transfemoral or trans-apical using the Edwards THV system, were not possible but successful implantation was achieved through the trans-aortic route.
Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. [2022]The purpose of this study was to evaluate the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position in patients with moderate to severe pulmonary regurgitation with or without stenosis.
New St. Jude Medical Portico™ transcatheter aortic valve: features and early results. [2013]Patients with symptomatic aortic valve disease who are inoperable or have high surgery-related risks may be treated with transcatheter aortic valve implantation devices. With this method increasingly applied, device innovations are aimed at achieving improved procedural results and therapeutic outcome. This paper describes the innovations implemented in the St. Jude Medical Portico™ system for transcatheter aortic valve implantation, the application of this system and initial clinical experience.
Transcatheter aortic valve replacement: a review of current indications and outcomes. [2014]In patients with symptomatic severe aortic stenosis, surgical aortic valve replacement (SAVR) improves survival, quality of life, and functional status compared with medical therapy. Based on the results of the randomized PARTNER Trial, Transcatheter Aortic Valve Replacement (TAVR) using the Edwards Sapien balloon expandable valve is now available in the United States for patients who are either inoperable due to anatomic concerns or severe medical co-morbidities, or as an alternative in patients considered high risk for SAVR. Fifty-six patients have been treated with TAVR at Rhode Island Hospital from March 2012 through October 2013 with similar outcomes to The PARTNER Trial and several large European registries. Second- generation valves and lower profile delivery systems designed to reduce the incidence of vascular complications, stroke, and perivalvular leak; and extension of TAVR to intermediate risk surgical patients, are under investigation.
Transthoracic access for transcatheter aortic valve replacement: technique using the Edwards Sapien Retroflex delivery system. [2014]We describe our experience using the Edwards Sapien transfemoral Retroflex 3 catheter delivery system for transcatheter aortic valve replacement through the transapical and transaortic approaches. Transthoracic transcatheter valve replacement by the transapical and transaortic approaches can be safely and effectively performed with the Retroflex 3 delivery catheter, which affords several advantages over other available delivery devices.
CRISP: Catheterization RISk score for Pediatrics: A Report from the Congenital Cardiac Interventional Study Consortium (CCISC). [2022]We sought to develop a scoring system that predicts the risk of serious adverse events (SAE's) for individual pediatric patients undergoing cardiac catheterization procedures.
Comparison of transcatheter aortic valve implantation with the newest-generation Sapien 3 vs. Direct Flow Medical valve in a single center cohort. [2017]The latest generation transcatheter heart valves including Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM) were designed to allow precise implantation at the intended position and to minimize prosthesis dysfunction as well as procedural complications. Our aim was to compare short-term functional and clinical outcomes of these 2 transcatheter aortic valve systems.
Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. [2019]The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position.
Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. [2019]Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the balloon-expandable Edwards SAPIEN valve in patients deemed in-operable and at high-risk, and later on in intermediate-risk patients using the balloon-expandable SAPIEN-XT valve. These trials had laid the groundwork for advancements incorporated in the balloon-expandable SAPIEN-3 system such as the introduction of the anti-leak skirt and improved delivery system. In this review, we summarize the available data on the SAPIEN-3 transcatheter heart valve system and we highlight the special features of the newly designed self-expanding Edwards CENTERA valve, and the latest generation of balloon-expanable SAPIEN-3 Ultra™ system. A detailed literature search on these devices was undertaken using Ovid, PubMed, and Web of Science. Expert commentary: Data from clinical trials show that TAVI with newer-generation of Edwards transcatheter heart valve systems have shown significant improvement in terms of reduced paravalvular leak and have been associated with extremely good clinical outcomes.
Evaluation of an electronic health record structured discharge summary to provide real time adverse event reporting in thoracic surgery. [2020]The reporting of adverse events (AE) remains an important part of quality improvement in thoracic surgery. The best methodology for AE reporting in surgery is unclear. An AE reporting system using an electronic discharge summary with embedded data collection fields, specifying surgical procedure and complications, was developed. The data are automatically transferred daily to a web-based reporting system.
The Need for Surgery After Vascular or Cardiac Trauma, or Technical Adverse Events in the Congenital Cardiac Catheterization Laboratory. [2023]Data on the frequency and outcome of surgical interventions as a result of adverse events (AE) encountered in the pediatric and congenital cardiac catheterization laboratory are limited. This study analyzes the outcomes of specific types of AE that are most likely to require immediate surgical intervention. Data from the C3PO registry were analyzed to identify specific types of significant vascular/cardiac trauma or technical adverse events (stent/device/coil embolization/migration). The relationship between these AE and an "adverse outcome" (defined as either surgery, ECMO, or death) were analyzed. Between 01/2014 and 12/2017, 25,731 cases were entered into the C3PO registry. Vascular or cardiac trauma were observed in 92 cases (0.36% cases in C3PO), and technical adverse events were observed in 176 cases (0.68% cases in C3PO). The two highest procedure type risk categories (PREDIC3T) accounted for 61% of the cases in the cardiac/vascular trauma cohort, and 34% in the technical AE cohort. For vascular/cardiac trauma, 24 (26%) had an adverse outcome, with ECMO in 8 (9%), surgery in 19 (20%), and death in 9 (10%). For technical AE 25 (14%) had an adverse outcome, with ECMO in 3 (2%), surgery in 23 (13%), and death in 3 (2%). Survival after cardiac surgery secondary to an AE was 68% for cardiac/vascular trauma, and 96% for technical adverse events. RF perforation of the pulmonary valve was the procedure most likely to result in cardiac/vascular trauma (10%), with 57% of those having an adverse outcome. Atrial septal interventions accounted for 29% of all adverse outcomes in the cardiac/vascular trauma cohort. Non-elective or emergent cases were associated with a significantly higher incidence of an adverse outcome for both, cardiac/vascular trauma (OR 7.1) and technical adverse events (OR 2.7). Surgery within the last 30 days was associated with a significantly higher incidence of an adverse outcome for cardiac/vascular trauma only (OR 4.2). Significant cardiac/vascular trauma or stent/device/coil embolization/migration are rare, but high consequence AE. With appropriate surgical and ECMO backup, a high survival can be achieved. The potential need for and impact of immediate surgical backup seems to be higher for cardiac/vascular trauma (in particular after specific case types), than for device/coil migration/embolization, and as such case specific backup arrangements are required.
Adverse events during endovascular treatment of ruptured aneurysms: A prospective nationwide study on subarachnoid hemorrhage in Sweden. [2023]A range of adverse events (AEs) may occur in patients with subarachnoid hemorrhage (SAH). Endovascular treatment is commonly used to prevent aneurysm re-rupture.