MitraClip for Severe TR (TVrepair)
Primary Purpose
Tricuspid Regurgitation
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MitraClip in tricuspid valve
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation
Eligibility Criteria
Inclusion Criteria:
- right-sided heart failure due to moderate-to-severe tricuspid regurgitation
- patients deemed inoperable by the heart Team
Exclusion Criteria:
- poor Echo-image quality
Sites / Locations
- Klinikum Großhadern University Hospital
Outcomes
Primary Outcome Measures
TR grade, Echo (grade 0-4)
grade 0-4: 0: no tricuspid regurgitation, 4: massive TR
MACCE
Secondary Outcome Measures
NYHA status
6 Minute walk distance
NT-proBNP
MLHFQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02863549
Brief Title
MitraClip for Severe TR
Acronym
TVrepair
Official Title
Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in selected, highly symptomatic patients with severe tricuspid regurgitation (TR).
Detailed Description
The primary objectives of this prospective analysis were to determine the feasibility in terms of success rate and short-term clinical follow-up at 30 days. In this context procedural success was defined as reduction of at least one TR grade. At 30-days after the procedure, a clinical follow up was performed in the heart failure outpatient clinic of our department including transthoracic echocardiography for the evaluation of TR grades. Furthermore, the investigators determined NYHA functional class and the incidence of major adverse cardiac and cerebrovascular events (MACCE).
Secondary objectives were the assessment of right ventricular function, the 6-minute walk distance, NT-proBNP as well as quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score at 30-days follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
MitraClip in tricuspid valve
Intervention Description
MitraClip in tricuspid valve
Primary Outcome Measure Information:
Title
TR grade, Echo (grade 0-4)
Description
grade 0-4: 0: no tricuspid regurgitation, 4: massive TR
Time Frame
1-12 months
Title
MACCE
Time Frame
1-12 months
Secondary Outcome Measure Information:
Title
NYHA status
Time Frame
1-12 months
Title
6 Minute walk distance
Time Frame
1-12 months
Title
NT-proBNP
Time Frame
1-12 months
Title
MLHFQ
Time Frame
1-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
right-sided heart failure due to moderate-to-severe tricuspid regurgitation
patients deemed inoperable by the heart Team
Exclusion Criteria:
poor Echo-image quality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Braun, MD
Phone
+49 89 4400
Ext
73052
Email
Daniel.Braun@med.uni-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Braun, MD
Organizational Affiliation
Klinikum der Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Großhadern University Hospital
City
München
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Braun, MD
Phone
+49 89 4400
Ext
73052
Email
Daniel.Braun@med.uni-muenchen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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MitraClip for Severe TR
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