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Procedure

AltaValve for Mitral Valve Regurgitation

N/A
Recruiting
Led By Philippe Genereux, MD
Research Sponsored by 4C Medical Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects symptomatic New York Heart Association (NYHA) II-IV
Be older than 18 years old
Must not have
Concurrent medical condition with a life expectancy of less than 12 months
Inability to understand the study or a history of non-compliance with medical advice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how safe and effective a new valve is for people who are at high risk for complications from open heart surgery.

Who is the study for?
This trial is for adults over 18 with moderate to severe mitral valve regurgitation who are at high risk for open-heart surgery. Participants should have symptoms classified as NYHA II-IV and cannot be pregnant, planning pregnancy, or enrolled in other conflicting studies. They must not have allergies to nitinol or contrast media that can't be managed with medication.
What is being tested?
The AltaValve Early Feasibility Study is testing the safety and performance of the AltaValve device in treating mitral valve regurgitation without conventional open-heart surgery. It's a prospective, single-arm study across multiple centers focusing on high-risk patients.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include those commonly associated with heart procedures such as bleeding, infection, allergic reactions to materials or medications used during the procedure, and possible impact on heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe heart condition symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a health condition that may limit my life to under a year.
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I understand the study and follow medical advice.
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I am not pregnant nor planning to become pregnant during the study.
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I am allergic or cannot take aspirin, heparin, or Warfarin and there are no good alternatives for me.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major Adverse Cardiac Event
Secondary study objectives
Device success
Procedural success
Technical success

Awards & Highlights

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

Find a Location

Who is running the clinical trial?

4C Medical Technologies, Inc.Lead Sponsor
1 Previous Clinical Trials
450 Total Patients Enrolled
Philippe Genereux, MDPrincipal InvestigatorMorristown Medical Center
Vinayak Bapat, MDPrincipal InvestigatorAllina Health System
2 Previous Clinical Trials
323 Total Patients Enrolled

Media Library

AltaValve (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03997305 — N/A
Mitral Valve Regurgitation Research Study Groups:
Mitral Valve Regurgitation Clinical Trial 2023: AltaValve Highlights & Side Effects. Trial Name: NCT03997305 — N/A
AltaValve (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997305 — N/A
~2 spots leftby Sep 2025
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