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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after the valve procedure for reporting.

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 more

JVTF EFS Trial Design

1Treatment groups

Experimental Treatment

Group I: J-Valve TF SystemExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

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

Frequently Asked Questions

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

Is enrollment for this research endeavor still available?

"Affirmative, the information hosted on clinicaltrials.gov confirms that this medical trial is actively recruiting. The experiment has been advertised since October 16th 2023 and was revised recently on November 9th of the same year. Currently, 15 individuals are needed to join from three distinct sites."

Answered by AI

How many individuals are being observed in this medical experiment?

"For the success of this medical study, 15 subjects need to be identified that meet the pre-defined inclusion criteria. These individuals can join from one of many locations such as Cardiovascular Institute of the South in Houma, Louisiana and The Christ Hospital in Cincinnati, Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

J-Valve TF Early Feasibility Study

2023. "J-Valve TF Early Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034028.

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