MedTrace Logo

AltaValve Early Feasibility Study Protocol

NCT03997305 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-01

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

AltaValve

Transcatheter Mitral Valve Replacement

Sponsors & Collaborators

  • 4C Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Philippe Genereux, MD · Morristown Medical Center

  • Vinayak Bapat, MD · Allina Health System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03997305 on ClinicalTrials.gov