Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)
NCT ID: NCT02515539
Last Updated: 2016-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-08-31
2021-07-31
Brief Summary
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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.
Detailed Description
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The primary objective of the study is to generate early feasibility data for the CardiAQ™ Transcatheter Mitral Valve Implant System with the Transfemoral and Transapical Delivery Systems for the treatment of moderate to severe mitral valve regurgitation in patients who are considered high risk for mortality and morbidity from conventional open-heart surgery.
The secondary objectives of the study are to evaluate the long-term safety of the device and the effects of the device on performance, functional, quality of life parameters, and technical, device, procedural, and individual patient successes.
The study is to be performed at a maximum of 5 investigational sites in the US.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CardiAQ TMVI System (Transapical & Transfemoral DS)
CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System
CardiAQ TMVI System (Transapical & Transfemoral DS)
CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System
Interventions
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CardiAQ TMVI System (Transapical & Transfemoral DS)
CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System
Eligibility Criteria
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Inclusion Criteria
* Left Ventricular Ejection Fraction ≥ 30%
* Mitral Regurgitation ≥ Grade 3+
* Subject meets anatomical and eligibility criteria for the investigational device
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Wilson Szeto, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Howard Herrmann, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Saibal Kar, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Alfredo Trento, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Countries
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Other Identifiers
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CIP-3103-01
Identifier Type: -
Identifier Source: org_study_id