NCT02863549

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

July 20, 2016

Last Update Submit

August 6, 2016

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

  • TR grade, Echo (grade 0-4)

    grade 0-4: 0: no tricuspid regurgitation, 4: massive TR

    1-12 months

  • MACCE

    1-12 months

Secondary Outcomes (4)

  • NYHA status

    1-12 months

  • 6 Minute walk distance

    1-12 months

  • NT-proBNP

    1-12 months

  • MLHFQ

    1-12 months

Interventions

MitraClip in tricuspid valveDEVICE

MitraClip in tricuspid valve

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • right-sided heart failure due to moderate-to-severe tricuspid regurgitation
  • patients deemed inoperable by the heart Team

You may not qualify if:

  • poor Echo-image quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Großhadern University Hospital

München, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Daniel Braun, MD

    Klinikum der Universität München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Braun, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Attending Physician

Study Record Dates

First Submitted

July 20, 2016

First Posted

August 11, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 11, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)