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Transcatheter Aortic Valve Replacement (TAVR)

JenaValve TAVR System for Aortic Stenosis

N/A
Waitlist Available
Led By Torsten 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 with severe degenerative native aortic stenosis (AS)
Patient at high risk for open surgical valve replacement
Must not have
Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
Endocarditis or other active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 day
Awards & highlights
No Placebo-Only Group

Summary

This trial is collecting information about treatment for severe aortic stenosis, which affects the aortic valve in the heart. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Who is the study for?
This trial is for patients with severe aortic stenosis, which narrows the heart's aortic valve and causes symptoms like chest pain. It's specifically for those at high risk from traditional surgery and who have significant symptoms (NYHA class II or higher). People with previous valve replacements, active infections, urgent TAVR needs, abnormal aortic valve morphology, or unstable heart conditions can't participate.
What is being tested?
The study is testing the JenaValve Pericardial TAVR System as a treatment option for severe aortic stenosis in patients who are considered high-risk candidates for conventional open-heart surgery. The goal is to improve blood flow by replacing the narrowed valve without needing major surgery.
What are the potential side effects?
Potential side effects of using the JenaValve system may include bleeding complications, irregular heart rhythms, stroke, infection risks associated with implant procedures, and possible damage to surrounding heart structures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe narrowing of my heart's aortic valve.
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I am considered high risk for traditional heart valve surgery.
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I have symptoms when I do physical activity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need medication or a device to help my heart pump blood.
Select...
I do not have an active infection or endocarditis.
Select...
I need an urgent heart valve replacement.
Select...
My aortic valve is naturally one or two-flapped.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All-Cause Mortality
Secondary study objectives
Acute Kidney Injury (AKI)
All Stroke/TIA
Conduction Disturbance and Arrhythmias
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.

Find a Location

Who is running the clinical trial?

JenaValve Technology, Inc.Lead Sponsor
7 Previous Clinical Trials
2,163 Total Patients Enrolled
3 Trials studying Aortic Valve Stenosis
817 Patients Enrolled for Aortic Valve Stenosis
Torsten Vahl, MDPrincipal InvestigatorNew York-Presbyterian Hospital/Columbia University Medical Center, USA
Vinod Thourani, MDPrincipal InvestigatorEmory University School of Medicine, USA
8 Previous Clinical Trials
4,493 Total Patients Enrolled
2 Trials studying Aortic Valve Stenosis
2,073 Patients Enrolled for Aortic Valve Stenosis
Martin B Leon, MDStudy ChairNew York-Presbyterian Hospital/Columbia University Medical Center, USA
11 Previous Clinical Trials
11,070 Total Patients Enrolled
5 Trials studying Aortic Valve Stenosis
5,306 Patients Enrolled for Aortic Valve Stenosis
Torsten P Vahl, MDPrincipal InvestigatorNew York-Presbyterian Hospital/Columbia University Medical Center, USA
1 Previous Clinical Trials
1,016 Total Patients Enrolled
Vinod H Thourani, MDPrincipal InvestigatorPiedmont Heart Institute, USA
1 Previous Clinical Trials
1,016 Total Patients Enrolled
Hendrik Treede, MDPrincipal InvestigatorUniversity Hospital Bonn, Germany
7 Previous Clinical Trials
2,012 Total Patients Enrolled
5 Trials studying Aortic Valve Stenosis
722 Patients Enrolled for Aortic Valve Stenosis

Media Library

JenaValve Pericardial TAVR System (Transcatheter Aortic Valve Replacement (TAVR)) Clinical Trial Eligibility Overview. Trial Name: NCT02732691 — N/A
Aortic Valve Stenosis Research Study Groups: Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Stenosis Clinical Trial 2023: JenaValve Pericardial TAVR System Highlights & Side Effects. Trial Name: NCT02732691 — N/A
JenaValve Pericardial TAVR System (Transcatheter Aortic Valve Replacement (TAVR)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02732691 — N/A
~7 spots leftby Dec 2025
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