AltaValve Early Feasibility Study Protocol

Mitral Regurgitation Clinical Trial

Official title:

AltaValve Early Feasibility Study Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997305
• Other study ID #: 1890
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: 4C Medical Technologies, Inc.
• Contact: Adam Lawrence
• Phone: +1-727-318-2203
• Email: AltaValveEFS[@]4CMed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Mitral Incompetence
• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Valve Incompetence
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• AltaValve
Transcatheter Mitral Valve Replacement

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Atrium Health	Charlotte	North Carolina
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Houston Methodist Hospital	Houston	Texas
United States	Baptist Memorial Hospital - Memphis	Memphis	Tennessee
United States	Morristown Medical Center	Morristown	New Jersey
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Baylor Scott & White	Plano	Texas
United States	Tampa General Hospital	Tampa	Florida
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Tucson Medical Center	Tucson	Arizona
United States	MedStar Washington Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
4C Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Event	Cardiac death, stroke, mitral valve related repeated intervention	30 days
Secondary	Technical success	Technical Success per MVARC criteria	Index procedure completion (Day 0)
Secondary	Procedural success	Device success and absence of major device or procedure related serious adverse events	30 days
Secondary	Device success	Device Success per MVARC criteria	30 days
Secondary	Change in MR grade		30 days