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Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)

NCT02515539 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-03-31

No results posted yet for this study

Summary

The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Conditions

Interventions

DEVICE

CardiAQ TMVI System (Transapical & Transfemoral DS)

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Wilson Szeto, MD · University of Pennsylvania

  • Howard Herrmann, MD · University of Pennsylvania

  • Saibal Kar, MD · Cedars-Sinai Medical Center

  • Alfredo Trento, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-08-31
Completion
2021-07-31

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Entities

Diseases

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 NCT02515539 on ClinicalTrials.gov