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Transcatheter Aortic Valve Replacement (TAVR)

JenaValve Pericardial TAVR System for Aortic Regurgitation

N/A

Waitlist Available

Led By Torsten P. Vahl, MD

Research Sponsored by JenaValve Technology, Inc.

Eligibility Criteria Checklist

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

Must have

Patient symptomatic according to NYHA functional class II or higher

Patient with severe aortic regurgitation (AR)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days and 1 year

Awards & highlights

Study Summary

This trialgathers info on treatment for severe aortic regurgitation, a heart valve condition. Symptoms incl. fatigue & shortness of breath. Surgery is the preferred treatment.

Who is the study for?

This trial is for patients with severe aortic regurgitation, who are at high risk for traditional open-heart valve replacement surgery. They should have symptoms that affect their daily activities (NYHA class II or higher). Participants must understand the study and agree to its terms with written consent. Those with abnormal aortic valve morphology, previous valve replacements, active infections, urgent heart conditions, or severe mitral regurgitation cannot join.Check my eligibility

What is being tested?

The ALIGN-AR EFS TRIAL is evaluating the JenaValve Pericardial TAVR System as a treatment option for severe Aortic Regurgitation. This condition causes blood to leak back into the heart chamber due to an improperly closing valve. The trial aims to gather data on this less invasive alternative to open-heart surgery.See study design

What are the potential side effects?

While specific side effects of the JenaValve system aren't listed here, similar procedures may include risks like bleeding, blood vessel complications, irregular heartbeats, stroke, infection at the catheter site and potential need for permanent pacemaker.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have symptoms when I do physical activity.

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I have severe leakage in my aortic valve.

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I am considered high risk for traditional heart valve surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 days and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30 days and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days 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

All-Cause Mortality at 30 days

Secondary outcome measures

Bleeding & Vascular Complications

Mortality

Peri-Procedural Myocardial Infarction

+1 more

Trial Design

1Treatment groups

Experimental Treatment

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

TAVR with JenaValve Pericardial Valve and Delivery System

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

JenaValve Technology, Inc.Lead Sponsor

5 Previous Clinical Trials

1,065 Total Patients Enrolled

Torsten P. Vahl, MDPrincipal InvestigatorNew York-Presbyterian/ Columbia University Medical Center

1 Previous Clinical Trials

180 Total Patients Enrolled

Vinod H. Thourani, MDPrincipal InvestigatorPiedmont Healthcare

3 Previous Clinical Trials

587 Total Patients Enrolled

Media Library

JenaValve Pericardial TAVR System (Transcatheter Aortic Valve Replacement (TAVR)) Clinical Trial Eligibility Overview. Trial Name: NCT02732704 — N/A

Aortic Regurgitation Research Study Groups: Transcatheter Aortic Valve Replacement (TAVR)

Aortic Regurgitation Clinical Trial 2023: JenaValve Pericardial TAVR System Highlights & Side Effects. Trial Name: NCT02732704 — N/A

JenaValve Pericardial TAVR System (Transcatheter Aortic Valve Replacement (TAVR)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02732704 — N/A

Frequently Asked Questions

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

Are there still opportunities available for individuals to participate in this investigation?

"According to clinicaltrials.gov, this specific study is no longer recruiting patients. The research was first uploaded on April 20th 2018 and last updated on November 16th 2022. Although the trial has ended recruitment, there are 22 other trials which remain open for enrollment at this time."

Answered by AI

How widespread is this clinical trial's implementation across North America?

"Nine medical centres are actively recruiting participants for this study, including the University of Washington in Seattle, Emory University Hospital in Atlanta and Baylor Scott & White Research Institute in Dallas. Additionally there is recruitment from 6 other sites."

Answered by AI

Recent research and studies

JACC: Cardiovascular InterventionsJournal

Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement with the Jenavalve Trilogy System

Hamid, Nadira, Lauren S. Ranard, Omar K. Khalique, Rebecca T. Hahn, Tamim M. Nazif, Isaac George, Vivian Ng, Martin B. Leon, Susheel K. Kodali, and Torsten P. Vahl. 2021. “Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement with the Jenavalve Trilogy System”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2021.07.025.

clinicaltrials.govStudy

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

2018. "THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02732704.