NCT03488732

Brief Summary

Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Apr 2015Jan 2030

Study Start

First participant enrolled

April 1, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

9.8 years

First QC Date

March 27, 2018

Last Update Submit

April 9, 2019

Conditions

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    10 years

Secondary Outcomes (3)

  • Cardiovascular mortality

    10 years

  • NYHA status

    10 years

  • Grade of mitral regurgitation

    10 years

Study Arms (1)

Patients undergonig transcatheter valvular interventions

Device: Transcatheter valvular repair or replacement

Interventions

Transcatheter valvular repair or replacementDEVICE

Transcatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis)

Patients undergonig transcatheter valvular interventions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing transcatheter valvular interventions

You may qualify if:

  • \- Severe valvular defect planned for valvular intervention

You may not qualify if:

  • \- No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Innere Medizin I

München, Germany

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Replantation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 5, 2018

Study Start

April 1, 2015

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2030

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

DE(1)