A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
Sponsor
Edwards Lifesciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT02478008
Collaborator
(none)
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2
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Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)
Study Start Date
:
Jun 1, 2015
Actual Primary Completion Date
:
Aug 1, 2015
Actual Study Completion Date
:
Aug 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CardiAQ TMVI System (Transapical DS)
|
Device: CardiAQ TMVI System (Transapical DS)
|
Outcome Measures
Primary Outcome Measures
- Composite Major Adverse Event Rate [30-Day]
- Composite Major Adverse Event Rate [12-Month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
NYHA Classification ≥ III
-
Left Ventricular Ejection Fraction ≥ 30%
-
Mitral regurgitation ≥ Grade 3+
-
Subject meets anatomical eligibility criteria for the investigational device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet University Hospital | Copenhagen | Denmark | ||
| 2 | Centre hospitalier régional universitaire de Lille | Lille | France | ||
| 3 | Hôpital Européen Georges-Pompidou | Paris | France | ||
| 4 | Centre Hospitalier Universiatier de Toulouse | Toulouse | France | ||
| 5 | Medisch Centrum Leeuwarden | Leeuwarden | Netherlands | ||
| 6 | St. Antonius Ziekenhuis | Nieuwegein | Netherlands | ||
| 7 | Erasmus University Medical Center | Rotterdam | Netherlands | ||
| 8 | Leeds General Infirmary | Leeds | United Kingdom | ||
| 9 | New Cross Hospital Heart Center | Wolverhampton | United Kingdom |
Sponsors and Collaborators
- Edwards Lifesciences
Investigators
- Principal Investigator: Lars Søndergaard, MD, DMSc, Rigshospitalet University Hospital (Copenhagen, Denmark)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02478008
Other Study ID Numbers:
- CIP-3102-01
First Posted:
Jun 23, 2015
Last Update Posted:
Mar 31, 2016
Last Verified:
Sep 1, 2015
Keywords provided by Edwards Lifesciences
Additional relevant MeSH terms: