MitraClip for Severe TR

NCT ID: NCT02863549

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Tricuspid Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MitraClip in tricuspid valve

MitraClip in tricuspid valve

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LMU Klinikum

OTHER

Sponsor Role: lead

Responsible Party

Daniel Braun, MD

MD, Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Braun, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universität München

Locations

Klinikum Großhadern University Hospital

München, Bavaria, Germany

Countries

Germany

Central Contacts

Daniel Braun, MD

Role: CONTACT

Daniel.Braun@med.uni-muenchen.de

+49 89 4400 ext. 73052

Facility Contacts

Daniel Braun, MD

Role: primary

Daniel.Braun@med.uni-muenchen.de

+49 89 4400 ext. 73052

Other Identifiers

MucS001-17

Identifier Type: -

Identifier Source: org_study_id