MitraClip for Severe TR

Tricuspid Regurgitation Clinical Trial

— TVrepair  

Official title:

Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02863549
• Other study ID #: MucS001-17
• Status: Not yet recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: August 6, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Klinikum der Universitaet Muenchen
• Contact: Daniel Braun, MD
• Phone: +49 89 4400
• Email: Daniel.Braun[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• MitraClip in tricuspid valve
MitraClip in tricuspid valve

Locations

Country	Name	City	State
Germany	Klinikum Großhadern University Hospital	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TR grade, Echo (grade 0-4)	grade 0-4: 0: no tricuspid regurgitation, 4: massive TR	1-12 months	No
Primary	MACCE		1-12 months	Yes
Secondary	NYHA status		1-12 months	No
Secondary	6 Minute walk distance		1-12 months	No
Secondary	NT-proBNP		1-12 months	No
Secondary	MLHFQ		1-12 months	No