Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Primary Cohort
Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC).
  • Device: AltaValve System.
    Transcatheter Mitral Valve Replacement.
Experimental
Mitral Annular Calcification Cohort (MAC)
Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC.
  • Device: AltaValve System.
    Transcatheter Mitral Valve Replacement.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Principal Investigator
713-500-3622
clinicaltrials@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
4C Medical Technologies, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.