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Clinical Trials/NCT02478008
NCT02478008
Terminated
Not Applicable

A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)

Edwards Lifesciences9 sites in 4 countries2 target enrollmentJune 2015
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ConditionsMitral InsufficiencyHeart Valve DiseaseCardiovascular DiseaseHeart Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Insufficiency
Sponsor
Edwards Lifesciences
Enrollment
2
Locations
9
Primary Endpoint
Composite Major Adverse Event Rate
Status
Terminated
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

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

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Edwards Lifesciences
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •NYHA Classification ≥ III
  • •Left Ventricular Ejection Fraction ≥ 30%
  • •Mitral regurgitation ≥ Grade 3+
  • •Subject meets anatomical eligibility criteria for the investigational device

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Composite Major Adverse Event Rate

Time Frame: 12-Month

Study Sites (9)

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