PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Completed

CT.gov ID

NCT05865938

Collaborator

(none)

214

Enrollment

Location

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation Functional Mitral Regurgitation Degenerative Mitral Valve Regurgitation	Device: PASCAL vs. MitraClip

Detailed Description

A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection.

Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols.

This study is a subproject of the MitraClip® Registry (NCT02033811)

Study Design

Study Type:

Observational

Actual Enrollment :

214 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Aug 31, 2022

Actual Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
PASCAL-Group M-TEER using MitraClip	Device: PASCAL vs. MitraClip transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.
MitraClip-Group M-TEER using PASCAL	Device: PASCAL vs. MitraClip transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.

Arm

Intervention/Treatment

PASCAL-Group

M-TEER using MitraClip

Device: PASCAL vs. MitraClip

transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.

MitraClip-Group

M-TEER using PASCAL

Device: PASCAL vs. MitraClip

Outcome Measures

Primary Outcome Measures

Procedural success [one month after implantation]
as defined by the Mitral Valve Academy Research Consortium (MVARC)
Composite endpoint of all-cause death and heart failure hospitalization [one year after implantation]

Secondary Outcome Measures

Grade of Mitral Regurgitation [one month and one year after implantation]
measured by echocardiography
Functional status [one month and one year after implantation]
according to New York Heart Association (NYHA) functional class

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years
Severe Mitral Regurgitation (3+ to 4+)
Symptom status: NYHA functional class ≥ II
Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high

Exclusion Criteria:

Life expectancy < 1 year
Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
Contraindication for transoesophageal echocardiography
Active endocarditis
Pregnant or planning pregnancy within next 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf		Germany	40225

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

Study Chair: Malte Kelm, Prof., Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Principal Investigator: Patrick Horn, MD, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Principal Investigator: Jafer Haschemi, MD, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf