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Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

NCT03016975 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-11-30

Study results available
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Summary

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

Conditions

  • Functional Mitral Regurgitation
  • Mitral Regurgitation
  • Mitral Insufficiency

Interventions

DEVICE

Edwards Cardioband System

Transcatheter mitral valve repair with the Edwards Cardioband System

DRUG

Guideline Directed Medical Therapy

GDMT Only

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Brian Whisenant, MD · Intermountain Medical Center

  • Vinod Thourani, MD · Piedmont Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-07-19
Completion
2022-09-20
FDA Device
Yes

Countries

  • United States

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 NCT03016975 on ClinicalTrials.gov