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Procedure
J-Valve TF System for Aortic Valve Disease (JVTF EFS Trial)
N/A
Recruiting
Led By Dean J Kereiakes, MD
Research Sponsored by JC Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has symptomatic severe native aortic regurgitation (AR) diagnosed by echocardiography
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after the valve procedure
Awards & highlights
JVTF EFS Trial Summary
This trial tests a new device to help treat severe aortic valve damage. It's preliminary safety & effectiveness will be assessed for patients at high risk for surgery.
Who is the study for?
This trial is for patients with severe aortic regurgitation who are at high risk for open heart surgery. Candidates must have the condition confirmed by echocardiography, suitable anatomy for the J-Valve implant, and agree to follow-up visits. Excluded are those with prohibitive surgical risks, mixed valve diseases, certain medical conditions like severe COPD or liver failure, known hypersensitivities, or other specific exclusions.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who can't undergo standard surgery. The device aims to replace dysfunctional valves without needing open heart surgery.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include bleeding complications, infection risks associated with implants, possible allergic reactions to materials used in the J-Valve system or related medications, and general risks involved in procedures affecting heart valves.
JVTF EFS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with severe aortic regurgitation.
JVTF EFS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after the valve procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after the valve procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients that do not experience death or disabling stroke
Secondary outcome measures
Number of patients achieving long-term clinical efficacy for valve function
Number of patients and procedures achieving device success
Number of patients and procedures achieving technical success
+6 moreJVTF EFS Trial Design
1Treatment groups
Experimental Treatment
Group I: J-Valve TF SystemExperimental Treatment1 Intervention
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Who is running the clinical trial?
JC Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
107 Total Patients Enrolled
2 Trials studying Aortic Valve Disease
107 Patients Enrolled for Aortic Valve Disease
Dean J Kereiakes, MDPrincipal InvestigatorThe Christ Hospital
6 Previous Clinical Trials
7,823 Total Patients Enrolled
Michael J Reardon, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
1 Previous Clinical Trials
1,425 Total Patients Enrolled
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