Transcatheter Tricuspid Valve Reconstruction for Tricuspid Regurgitation
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Edwards Lifesciences
Must not be taking: Antiplatelets, Anticoagulants
Disqualifiers: Severe valve stenosis, Active infection, Recent stroke, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Clinical Study of the Edwards Cardioband FIT Repair System
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have a hypersensitivity or contraindication to antiplatelets, anticoagulants, or other specified materials, you may not be eligible to participate.
What data supports the effectiveness of the treatment Edwards Cardioband Tricuspid Valve Reconstruction System for tricuspid regurgitation?
The Cardioband system, used for tricuspid regurgitation, has shown promising early results in reducing valve leakage and improving patient quality of life, similar to its success in treating mitral regurgitation. However, there are potential complications, such as temporary deformation of nearby arteries, that should be considered.
12345Is the Cardioband Tricuspid Valve Reconstruction System safe for humans?
The Cardioband Tricuspid Valve Reconstruction System has been associated with some safety concerns, such as temporary deformation or blockage of the right coronary artery (a major heart artery) and issues with the device's adjustment mechanism. These complications have been managed successfully in reported cases, but they highlight potential risks that should be considered.
12367How is the Edwards Cardioband Tricuspid Valve Reconstruction System treatment different from other treatments for tricuspid regurgitation?
The Edwards Cardioband Tricuspid Valve Reconstruction System is unique because it is a transcatheter treatment, meaning it is delivered through a catheter (a thin tube) rather than open-heart surgery, which makes it less invasive compared to traditional surgical options for tricuspid regurgitation.
89101112Eligibility Criteria
This trial is for adults with chronic functional tricuspid regurgitation (moderate or greater) who still have symptoms despite medical treatment. Candidates should be deemed appropriate for the procedure by a Heart Team but cannot have unsuitable anatomy, primary valve disease, prior repairs or replacements, or conditions that may affect study participation.Inclusion Criteria
I have a long-term moderate or severe leak in my heart valve.
I have heart issues related to tricuspid regurgitation that aren't improving with current treatment.
My heart team has approved me for a specific heart valve procedure.
Exclusion Criteria
My body's structure makes me ineligible for the procedure.
My heart condition is related to the tricuspid valve.
Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive treatment with the Edwards Cardioband FIT Repair System
2-7 days
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Multiple visits (in-person) at 30 days and 1 year
Participant Groups
The Edwards Cardioband Tricuspid Valve Reconstruction System is being tested in this clinical study. It's a minimally invasive procedure designed to repair the heart's tricuspid valve without needing open-heart surgery.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the Edwards Cardioband FIT Repair System
Edwards Cardioband Tricuspid Valve Reconstruction System is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as Edwards Cardioband Tricuspid Valve Reconstruction System for:
- Tricuspid regurgitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Heart Hosiptal Baylor PlanoPlano, TX
Mayo ClinicRochester, MN
Columbia University Medical Center /New York Presbyterian HospitalNew York, NY
Lankenau Medical CenterWynnewood, PA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Edwards LifesciencesLead Sponsor
References
Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system. [2023]The Cardioband tricuspid valve reconstruction system is a size-adjustable tricuspid reconstruction device for interventional treatment of tricuspid regurgitation (TR). Contraction of the device after successful implantation can be associated with an acute deformation of the right coronary artery (RCA).
Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. [2021]The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR).
Subtotal occlusion of the right coronary artery by Cardioband and its successful intervention via retrograde approach. Interventional flashlight. [2023]In recent years, transcatheter approaches have changed the therapy of valvular regurgitation. One of these new techniques is the Cardioband ® tricuspid valve reconstruction system (Edwards Lifesciences Corp., Irvine, CA, USA), which allows an adjustment of the ring size but may cause a temporary deformation or even occlusion of the right coronary artery (RCA) due to its close proximity. We report on a patient with symptomatic and subtotal occlusion of the RCA after Cardioband implantation. The distortion was so sharp-cornered that antegrade re-canalizations failed. Finally, the subtotal occlusion was re-opened via retrograde approach and this stent remained open in long-term follow-up. We think this complication should be known and considered when using the Cardioband system.
The Cardioband transcatheter annular reduction system. [2020]Surgical implantation of a complete or incomplete ring to reduce the mitral valve annulus and improve leaflet coaptation is the foundation of valve repair for degenerative and functional mitral and tricuspid regurgitation. The Cardioband system (Edwards Lifesciences, Irvine, CA, USA) is a catheter-delivered annular reduction system that mimics the surgical approach. Sequential anchors are used to secure the Cardioband implant from trigone to trigone. The Cardioband implant is contracted under transesophageal guidance until valvular regurgitation is reduced. In the initial clinical experience, the Cardioband system was safely deployed in patients with clinically significant functional mitral regurgitation (MR) and yielded durable MR reduction, improved quality of life, and improved exercise capacity. The early and still-evolving Cardioband experience for tricuspid regurgitation is also promising. The ongoing pivotal ACTIVE Trial is designed to demonstrate the superiority of the Cardioband system to guideline-directed medical therapy in patients with clinically significant functional MR (FMR) using a composite endpoint of mortality, heart failure (HF) hospitalization, quality of life, and exercise capacity.
Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. [2020]The Cardioband™ (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016.
Tricuspid valve in valve procedure with an Edwards S3 valve© in a 10 kg child. [2022]A 4-year-old child of 10 kg weight, with four previous sternotomies, presented a severe right heart failure, due to a severe regurgitation of his bioprosthetic tricuspid valve. A percutaneous tricuspid valve in valve procedure with an Edwards S3 valve was offered for compassionate use, and performed, with no complications, and significant clinical condition improvement.
Tangled wire in a Dacron band during Cardioband transcatheter tricuspid annuloplasty-How to solve the problem. [2021]Transcatheter tricuspid valve intervention (TTVI) is an emerging treatment for patients with symptomatic severe tricuspid regurgitation (TR). Currently, the issues that arise during TTVI are unclear. Here, a 78-year-old woman with severe TR underwent transcatheter tricuspid valve annuloplasty using a Cardioband (Edwards Lifesciences, Irvine, CA). We attempted to cinch the Dacron band after anchoring; however, it was impossible to connect the distal tip of the size adjustment tool and the Dacron band because the cinching wire was tangled around the Dacron band. We resolved this issue without surgical intervention, and eventually cinched the annulus. Final echocardiography revealed dramatic TR reduction. To our knowledge, no study has reported a tangled wire in a Dacron band during Cardioband use. Clinicians should be aware of the risks accompanying this concern in case where it is impossible to connect the distal tip of the size adjustment tool and the Dacron band during cinching.
Recurrent trigeminocardiac reflex in percutaneous balloon compression for trigeminal neuralgia: A case report. [2022]Trigeminocardiac reflex (TCR) sometimes occurs during the percutaneous balloon compression (PBC) procedure to treat trigeminal neuralgia (TN), and it manifests as transient bradycardia or sinus arrest. However, recurrent intraoperative TCR cases are rarely reported. Meanwhile, the treatment for recurrent TCR is still unclear.
Case report: 2 cases of cardiac arrest caused by rhino-cardiac reflex while disinfecting nasal cavity before endonasal transsphenoidal endoscopic pituitary surgery. [2021]Trigeminal-cardiac reflex (TCR) is a brainstem vagus reflex that occurs when any center or peripheral branch of the trigeminal nerve was stimulated or operated on. The typical clinical manifestation is sudden bradycardia with or without blood pressure decline. The rhino-cardiac reflex which is one type of TCR is rare in clinical practice. As the rhino-cardiac reflex caused by disinfection of the nasal cavity is very rare, we report these two cases to remind other anesthesiologists to be vigilant to this situation.
Management of middle meningeal and superficial temporal artery hemorrhage from total temporomandibular joint replacement surgery with a gelatin-based hemostatic agent. [2019]Complications associated with temporomandibular joint (TMJ) replacement surgery may include injury to nerves, blood vessels, and otologic structures. Vascular injuries can be associated with trauma to the carotid artery and its terminal branches, the superficial temporal artery, and the internal maxillary artery. Suggested management to control hemorrhage has included uniand bipolar electrocautery, laser ablation, local anesthetics with vasoconstrictors, direct pressure, embolization, and ligation. In this case report, the iatrogenic injury to both the middle meningeal and superficial temporal arteries during total TMJ replacement surgery controlled by using a gelatin-based hemostatic agent is discussed.
Intra-Arterial Lidocaine Blunts the Trigeminocardiac Reflex during Endovascular Treatment of a Carotid-Cavernous Fistula. [2021]Carotid-cavernous fistulas (CCFs) are vascular shunts that allow blood to flow from the carotid artery or its branches into the cavernous sinus. Endovascular embolization is the treatment modality of choice. The trigeminocardiac reflex (TCR) is a vagally mediated reflex that can lead to hemodynamic instability. It can be activated during embolization procedures due to the proximity of vagal efferent neurovascular structures within the cavernous sinus. This case report describes the intraoperative management of recurrent, profound bradycardia due to TCR during endovascular CCF embolization.
Trigeminocardiac reflex during non-surgical root canal treatment of teeth with irreversible pulpitis. [2018]Trigeminocardiac reflex (TCR) is a unique clinical incident of acute change in hemodynamic balance, which may lead to hypotension, bradycardia, and even clinical crisis. Up to date, no study so far considers the impact of non-surgical root canal treatment (NSRCT) of irreversible pulpitis teeth under either local infiltration or block anesthesia on hemodynamic change possibly related to TCR.