NCT04473092

Brief Summary

To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

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

First Submitted

Initial submission to the registry

July 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

July 13, 2020

Last Update Submit

November 2, 2022

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Morphologic and functional changes of mitral valve anatomy

    1 year

Interventions

TMVRDEVICE

Patients who undergo TMVR for MR at the PI´s site

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who undergo TVMR for MR (age \>18yrs) at the PI´s site

You may qualify if:

  • All patients who undergo TVMR for MR (age \>18yrs) at the PI´s site

You may not qualify if:

  • \<18yry
  • Subject does not provide full consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine

Essen, North Rhine-Westphalia, 45147, Germany

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Peter Lüdike, MD

    University Hospital Essen, Westgerman Heart- and Vascular Center, Department of Cardiology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 16, 2020

Study Start

July 20, 2020

Primary Completion

September 20, 2022

Study Completion

September 30, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)