AltaValve Early Feasibility Study Protocol

Not Applicable

Recruiting

• Conditions: Mitral Valve Incompetence; Mitral Valve Regurgitation; Mitral Regurgitation; Mitral Incompetence; Mitral Insufficiency

• Registration Number: NCT03997305
• Lead Sponsor: 4C Medical Technologies, Inc.

Brief Summary

Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-25
• Study Start: 2019-12-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Subjects ≥ 18 years of age.
2. Subjects symptomatic New York Heart Association (NYHA) II-IV.
3. Subjects with severe MR as documented by echo.
4. Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).

Abbreviated

Exclusion Criteria

1. Inability to understand the study or a history of non-compliance with medical advice.
2. Unwilling or unable to sign the Informed Consent Form (ICF).
3. History of any cognitive or mental health status that would interfere with study participation.
4. Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
5. Female subjects who are pregnant or planning to become pregnant within the study period.
6. Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
7. Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
8. Known hypersensitivity to contrast media that cannot be adequately medicated.
9. Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
10. Concurrent medical condition with a life expectancy of less than 12 months.
11. Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Event	30 days	Cardiac death, stroke, mitral valve related repeated intervention

Secondary Outcome Measures

Name	Time	Method
Device success	30 days	Device Success per MVARC criteria
Change in MR grade	30 days
Technical success	Index procedure completion (Day 0)	Technical Success per MVARC criteria
Procedural success	30 days	Device success and absence of major device or procedure related serious adverse events

Trial Locations

Locations (12)

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

MedStar Washington Hospital; 🇺🇸 Washington, District of Columbia, United States

Los Robles Regional Medical Center; 🇺🇸 Thousand Oaks, California, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Oklahoma Heart Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States

Baptist Memorial Hospital - Memphis; 🇺🇸 Memphis, Tennessee, United States

Baylor Scott & White; 🇺🇸 Plano, Texas, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States