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AltaValve Pivotal Trial

NCT06465745 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-05-02

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

AltaValve System.

Transcatheter Mitral Valve Replacement.

Sponsors & Collaborators

  • 4C Medical Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2029-09-30
Completion
2031-09-30
FDA Device
Yes

Countries

  • United States
  • Germany
  • Greece
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06465745 on ClinicalTrials.gov