Clinical trial NCT03503851: Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation
Official title: Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation (One-Plus-One)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mitral Regurgitation Functional
Keywords: Mitral Regurgitation
transcatheter mitral valve repair
MitraClip
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2018-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center, randomized, parallel-arm trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluation of number of participants who died death within one year
timeFrame: 1 year
measure: Evaluation of number of rehospitalizations due to heart failure among patients receiving one or two clips
timeFrame: 1 year
measure: Evaluation of number of participants with recurrent regurgitation within one year
timeFrame: 1 year
Secondary outcomes:
measure: death
timeFrame: 1 year
measure: heart failure
timeFrame: 1 year
measure: rehospitalization
timeFrame: 1-year
measure: regurgitation
timeFrame: 1-year
measure: success rate
timeFrame: 1-year
measure: procedure duration
timeFrame: 1-year
measure: total device time
timeFrame: 1-year
measure: fluoroscopy time
timeFrame: 1-year
measure: contrast volume
timeFrame: 1-year
measure: complications
timeFrame: 1-year
measure: echocardiographic variables
timeFrame: 1-year
measure: changes in echocardiographic variables
timeFrame: 1-year
measure: NYHA
timeFrame: 1-year
measure: 6-minutes walk
timeFrame: 1-year
measure: quality of life
timeFrame: 1-year
Other outcomes:
Locations:
Study officials:
affiliation: Asklepios Klinik St. Georg, Dept. of Cardiology
name: Karl-Heinz Kuck, MD, PHD
role: PRINCIPAL_INVESTIGATOR
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