NCT03104660

Brief Summary

To evaluate the long-term results after transcatheter mitral valve repair

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

April 3, 2017

Last Update Submit

April 25, 2020

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Major adverse cerebral and cardiac events

    Major adverse cerebral and cardiac events

    10 years

Study Arms (1)

CE certified mitral valve repair systems

EXPERIMENTAL

CE certified transcatheter mitral valve repair systems

Device: CE certified mitral valve repair systems

Interventions

CE certified mitral valve repair systemsDEVICE

Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.

CE certified mitral valve repair systems

Eligibility Criteria

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

You may qualify if:

  • mitral valve regurgitation
  • transcatheter mitral valve repair

You may not qualify if:

  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ulm

Ulm, 89081, Germany

Location

Related Publications (2)

  • Seeger J, Markovic S, Kessler M, Rottbauer W, Wohrle J. Apixaban After Percutaneous Edge-to-Edge Mitral Valve Repair in Patients With Maintained Sinus Rhythm. JACC Cardiovasc Interv. 2019 Jan 28;12(2):214-216. doi: 10.1016/j.jcin.2018.11.009. No abstract available.

    PMID: 30678801RESULT

  • Seeger J, Muller P, Gonska B, Scharnbeck D, Markovic S, Walcher D, Rottbauer W, Wohrle J. Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria. J Invasive Cardiol. 2017 Apr;29(4):145-150.

    PMID: 28368846RESULT

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Jochen Woehrle, MD

    University Hospital Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: CE certified mitral valve repair systems
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 7, 2017

Study Start

March 15, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)