Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation (One-Plus-One)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation Functional
- Sponsor
- Asklepios proresearch
- Primary Endpoint
- Evaluation of number of participants who died death within one year
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.
Detailed Description
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR. Purpose To demonstrate the noninferiority of a 1-clip strategy vs. a 2-clip strategy of MitraClip implantation, when the second clip in the 2-clip study arm is implanted for stabilizing/supporting purposes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Absence of a structural abnormality of the mitral valve giving rise to MR.
- •MR severity of US grade 3+ or 4+ of central or noncentral origin
- •Patient must consent to randomization in the hybrid operating theater upon successful implantation of a single MitraClip. Written informed consent must be provided prior to the MitraClip procedure.
Exclusion Criteria
- •patients with primary regurgitation
Outcomes
Primary Outcomes
Evaluation of number of participants who died death within one year
Time Frame: 1 year
death
Evaluation of number of rehospitalizations due to heart failure among patients receiving one or two clips
Time Frame: 1 year
heart failure rehospitalization
Evaluation of number of participants with recurrent regurgitation within one year
Time Frame: 1 year
recurrence of mitral regurgitation (\>grade 2+ at 1 year)
Secondary Outcomes
- heart failure(1 year)
- total device time(1-year)
- NYHA(1-year)
- 6-minutes walk(1-year)
- fluoroscopy time(1-year)
- changes in echocardiographic variables(1-year)
- quality of life(1-year)
- rehospitalization(1-year)
- regurgitation(1-year)
- contrast volume(1-year)
- death(1 year)
- success rate(1-year)
- procedure duration(1-year)
- complications(1-year)
- echocardiographic variables(1-year)