Back to resultsA Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
Primary Purpose
Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CardiAQ TMVI System (Transapical DS)
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Insufficiency focused on measuring Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical
Eligibility Criteria
Key Inclusion Criteria:
- NYHA Classification ≥ III
- Left Ventricular Ejection Fraction ≥ 30%
- Mitral regurgitation ≥ Grade 3+
- Subject meets anatomical eligibility criteria for the investigational device
Sites / Locations
- Rigshospitalet University Hospital
- Centre hospitalier régional universitaire de Lille
- Hôpital Européen Georges-Pompidou
- Centre Hospitalier Universiatier de Toulouse
- Medisch Centrum Leeuwarden
- St. Antonius Ziekenhuis
- Erasmus University Medical Center
- Leeds General Infirmary
- New Cross Hospital Heart Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CardiAQ TMVI System (Transapical DS)
Arm Description
Outcomes
Primary Outcome Measures
Composite Major Adverse Event Rate
Composite Major Adverse Event Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02478008
Brief Title
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
Official Title
A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Edwards acquired CardiAQ and opted to terminate this study. 2 patients were enrolled and follow-up is complete. No further enrollment or follow-up will occur.
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
Keywords
Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CardiAQ TMVI System (Transapical DS)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CardiAQ TMVI System (Transapical DS)
Primary Outcome Measure Information:
Title
Composite Major Adverse Event Rate
Time Frame
30-Day
Title
Composite Major Adverse Event Rate
Time Frame
12-Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
NYHA Classification ≥ III
Left Ventricular Ejection Fraction ≥ 30%
Mitral regurgitation ≥ Grade 3+
Subject meets anatomical eligibility criteria for the investigational device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Søndergaard, MD, DMSc
Organizational Affiliation
Rigshospitalet University Hospital (Copenhagen, Denmark)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Centre hospitalier régional universitaire de Lille
City
Lille
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
Country
France
Facility Name
Centre Hospitalier Universiatier de Toulouse
City
Toulouse
Country
France
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
New Cross Hospital Heart Center
City
Wolverhampton
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
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