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Transcatheter Heart Valve

SAPIEN X4 THV for Failing Aortic Valves

N/A

Recruiting

Led By Tamim M. Nazif, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial tests a new heart valve to see if it is safe and effective for people with failing aortic valves.

Who is the study for?

This trial is for adults with a failing aortic bioprosthetic valve who are at high surgical risk. They must have symptoms of heart dysfunction (NYHA class ≥ II) and be suitable for the SAPIEN X4 THV based on their valve size. Participants need to consent to study provisions. Exclusions include unstable valves, severe mitral issues, blood disorders, recent major cardiac events or procedures, pregnancy, certain anatomical features that complicate the procedure, active COVID-19 infection or related sequelae.Check my eligibility

What is being tested?

The Edwards SAPIEN X4 Transcatheter Heart Valve (THV) is being tested for safety and effectiveness in patients with failing aortic bioprosthetic valves who face high risks from traditional surgery. The study will evaluate how well this new device works as an alternative to replace dysfunctional heart valves without open-heart surgery.See study design

What are the potential side effects?

Potential side effects may include bleeding complications due to antithrombotic therapy required after implantation; risk of stroke; vascular complications from femoral sheath placement; irregular heartbeat requiring pacemaker insertion; infections like endocarditis; and potential damage to surrounding structures during implantation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Non-hierarchical composite of death and stroke

Secondary outcome measures

KCCQ score

Kansas City Cardiomyopathy Questionnaire (KCCQ) score

NYHA functional class

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transcatheter Aortic Valve Replacement (TAVR) - THVExperimental Treatment1 Intervention

TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).

Group II: Transcatheter Aortic Valve Replacement (TAVR) - Surgical ValveExperimental Treatment1 Intervention

TAVR implant in subjects with a failing aortic surgical valve.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

61,374 Total Patients Enrolled

Tamim M. Nazif, MDPrincipal InvestigatorColumbia University

1 Previous Clinical Trials

915 Total Patients Enrolled

Rahul P. Sharma, MBBSPrincipal InvestigatorStanford University

1 Previous Clinical Trials

915 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots remaining in this experiment?

"According to the information found on clinicaltrials.gov, recruitment for this trial is currently ongoing. The date of its initial posting was December 1st 2023 and it has been updated as recently as November 9th 2023."

Answered by AI

How many centers are overseeing this research endeavor?

"Prospective participants can register for this medical trial at Naples Community Hospital Healthcare System in Florida, Piedmont Heart Institute in Georgia and University of Texas Memorial Hermann in Houston as well as 5 other sites."

Answered by AI

How many participants have been enlisted in this trial thus far?

"This research necessitates the recruitment of 200 volunteers who meet the predetermined eligibility requirements. Individuals may join this clinical trial at Naples Community Hospital Healthcare System in Florida and Piedmont Heart Institute in Georgia, among other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

2023. "ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05172973.

All > Aortic Stenosis