To demonstrate the safety, efficacy, and performance of the Edwards Lifesciences MONARCTM system for the treatment of functional mitral regurgitation
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is the individual rate of the following events:
Death, Myocardial Infarction (Q-wave or Non-Q-wave having total CK >2X normal
with any CKMB > normal or elevated Troponin above institution*s upper level)
and Cardiac tamponade within 30 days of date of implantation.
The primary efficacy endpoint is the percentage of subjects with a one-grade or
greater reduction in severity of mitral regurgitation at 6 and 12 months
(compared to baseline).
Secondary outcome
Percentage of subjects with MR severity of 2+ of less.
Percentage of subjects with a one-grade of greater reduction in severity of
mitralregurgitation.
Frequency of rehospitalization for CHF.
Hemodynamic Parameters Evaluation via TTE.
Clinical funcionale status evaluation.
Quality of Life Assessment.
Background summary
Treatment options for functional MR in patients with heartfailure are limited.
Surgery is associated with a high rate of complications. Annuloplasty throught
a percutaneous approach involving a device inserted into the coronary sinus has
proven to be possible. This offers patients with heartfailure a chance to treat
functional MR without the risk of open heart surgery.
Study objective
To demonstrate the safety, efficacy, and performance of the Edwards
Lifesciences MONARCTM system for the treatment of functional mitral
regurgitation
Study design
Multi-center, prospective, non-randomized study
Intervention
Implant Edwards Monarc Lifesciences system
Study burden and risks
Please refer to par. 2.3, pag. 12-14 of the protocol.
Route de L'Etraz 70
1260 Nyon
CH
Route de L'Etraz 70
1260 Nyon
CH
Listed location countries
Age
Inclusion criteria
- functional mitral valve regurgitation
- ischemic or idiopathic cardiomyopathy
- NYHA Class II-IV
- Moderatre to severe mitral regurgitation
- Ability to perform 6 minute walk: 150-450 meters
Exclusion criteria
- subjects who are eligible for biventricular pacing leads within the coronary sinus
- active endocarditis
- prior mitral valve repair of replacement
- serum creatinine leven > 2.0mg/dl
- allergy to anticoagulation medications or contrast media
- aortic valve disease that requires surgical intervention
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28930.041.09 |