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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
Subjects ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major Adverse Cardiac Event
Secondary outcome measures
Change in MR grade
Device success
Procedural success
+1 more

Find a Location

Who is running the clinical trial?

4C Medical Technologies, Inc.Lead Sponsor
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

Frequently Asked Questions

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

What is the current participant count for this experiment?

"With 15 total participants, the sponsor of this research, 4C Medical Technologies Inc., is running it from two major sites: Los Robles Regional Medical Center in Thousand Oaks and Brigham & Women's Hospital located in Boston."

Answered by AI

Are there any current opportunities to participate in this experiment?

"According to clinicaltrials.gov, this medical research is currently open for enrolment. The protocol was initially published on December 4th 2019 and recently amended on November 16th 2022."

Answered by AI

How many facilities are currently offering this clinical endeavor?

"Patients are currently being enrolled in this medical trial from 15 different sites, such as Los Robles Regional Medical Center in Thousand Oaks California, Brigham & Women's Hospital in Boston Massachusetts and Prairie Heart Institute in Springfield Illinois."

Answered by AI

Who else is applying?

What site did they apply to?
Oklahoma Heart Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Sep 2025