MitraClip for Severe TR

Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02863549

Acronym

TVrepair

Enrollment

100

Registered

2016-08-11

Start date

2016-07-31

Completion date

2017-12-31

Last updated

2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Regurgitation

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.

Interventions

DEVICEMitraClip in tricuspid valve

MitraClip in tricuspid valve

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
TR grade, Echo (grade 0-4)	1-12 months	grade 0-4: 0: no tricuspid regurgitation, 4: massive TR
MACCE	1-12 months	—

Secondary

Measure	Time frame
NYHA status	1-12 months
6 Minute walk distance	1-12 months
NT-proBNP	1-12 months
MLHFQ	1-12 months

Countries

Germany

Contacts

Primary ContactDaniel Braun, MD

Daniel.Braun@med.uni-muenchen.de+49 89 4400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026