Clinical trial NCT06465745: AltaValve Pivotal Trial
Official title: AltaValve Pivotal Trial
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
Transcatheter Mitral Valve Replacement
Primary Regurgitation
Secondary Regurgitation
Lead sponsor: 4C Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Symptomatic New York Heart Association (NYHA) class II-IV.
* Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
* Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.

Exclusion Criteria (Abbreviated List):

* Inability to understand the trial or a history of non-compliance with medical advice.
* Inability to provide signed Informed Consent Form (ICF).
* History of any cognitive or mental health status that would interfere with participation in the trial.
* Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
* Female subjects who are pregnant or planning to become pregnant within the trial period.
* Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
* Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
* Known hypersensitivity to contrast media that cannot be adequately medicated.
* Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
* Concurrent medical condition with a life expectancy of less than 12 months.
* Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
* Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.

Primary outcomes:
measure: Composite of all-cause mortality or heart failure hospitalization.
timeFrame: 12 months.
Secondary outcomes:
measure: All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention.
timeFrame: 30 Days or hospital discharge (whichever is longer).
measure: Technical success.
timeFrame: Day 0.
measure: Mitral valve re-intervention.
timeFrame: At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.
measure: Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).
timeFrame: 6 months and 1 year.
measure: Changes in Six-minute walk test (6MWT).
timeFrame: 6 months and 1 year.
measure: New pacemaker rate.
timeFrame: 1 month, 6 months and 1 year.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Dignity Health; St. Joseph's Hospital and Medical Center
state: Arizona
city: Tucson
country: United States
facility: TMC Healthcare
state: Arizona
city: San Francisco
country: United States
facility: Sutter Bay Hospitals
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital & Medical Center
state: California
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Columbia
country: United States
facility: MedStar Health Research Institute, Inc.
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Morristown
country: United States
facility: AHS Hospital Corp.
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: The Charlotte-Mecklenburg Hospital; Atrium Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research, LLC.
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Cologne
country: Germany
facility: University Hospital Cologne - Heart Center
city: Dortmund
country: Germany
facility: Cardiac Research GmbH; St.-Johannes-Hospital Dortmund
city: Trier
country: Germany
facility: Heart Center Trier
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center of Thessaloniki
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Fundación para la investigación biomédica del hospital clínico San Carlos
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
References: