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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 day
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have severe narrowing of my heart's aortic valve.
Select...
I am considered high risk for traditional heart valve surgery.
Select...
I have symptoms when I do physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 day
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
Secondary outcome measures
Acute Kidney Injury (AKI)
All Stroke/TIA
Conduction Disturbance and Arrhythmias
+7 moreTrial 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.
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Who is running the clinical trial?
JenaValve Technology, Inc.Lead Sponsor
5 Previous Clinical Trials
1,097 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
7 Previous Clinical Trials
4,443 Total Patients Enrolled
2 Trials studying Aortic Valve Stenosis
2,073 Patients Enrolled for Aortic Valve Stenosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication or a device to help my heart pump blood.I have severe narrowing of my heart's aortic valve.I do not have an active infection or endocarditis.I need an urgent heart valve replacement.I am considered high risk for traditional heart valve surgery.My aortic valve is naturally one or two-flapped.I have symptoms when I do physical activity.
Research Study Groups:
This trial has the following groups:- Group 1: Transcatheter Aortic Valve Replacement (TAVR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What aims are researchers hoping to achieve through this clinical experiment?
"As reported by JenaValve Technology, Inc., the primary measure of effectiveness over a 30 day period is All-Cause Mortality. Additionally, secondary outcomes include Coronary Obstruction Requiring Intervention, All Stroke/TIA occurrences and Endocarditis."
Answered by AI
Are there any slots left for participants in this research project?
"Unfortunately, the information posted on clinicaltrials.gov denotes that this study is not currently accepting participants. This trial was originally launched in October 2016 and had its last update at the end of October 2022, however there are 1,018 other studies still actively enrolling individuals as we speak."
Answered by AI
How many sites are offering participation in this clinical experiment?
"Presently, this investigation is being carried out across 6 distinct sites. In addition to Washington, New york and Ann Arbor there are 3 other places involved in the trial. To minimize travel needs for participants it is sensible to select a location closeby."
Answered by AI
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