Clinical trial NCT03997305: AltaValve Early Feasibility Study Protocol
Official title: AltaValve Early Feasibility Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Incompetence
Mitral Valve Regurgitation
Mitral Incompetence
Keywords: Mitral Regurgitation
TMVR
Functional Regurgitation
Degenerative Regurgitation
Transcathether Mitral Valve Replacement
Primary Regurgitation
Secondary Regurgitation
Lead sponsor: 4C Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Major Adverse Cardiac Event
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: Index procedure completion (Day 0)
measure: Procedural success
timeFrame: 30 days
measure: Device success
timeFrame: 30 days
measure: Change in MR grade
timeFrame: 30 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Memphis
country: United States
facility: Baptist Memorial Hospital - Memphis
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White
state: Texas
Study officials:
affiliation: Morristown Medical Center
name: Philippe Genereux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Allina Health System
name: Vinayak Bapat, MD
role: PRINCIPAL_INVESTIGATOR
References: