Clinical trial NCT05865938: PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair
Official title: PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Functional Mitral Regurgitation
Degenerative Mitral Valve Regurgitation
Keywords: Mitral Regurgitation
Functional Mitral Regurgitation
Degenerative Mitral Valve Regurgitation
M-TEER
TEER
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe symptomatic mitral regurgitation.

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Procedural success
timeFrame: one month after implantation
measure: Composite endpoint of all-cause death and heart failure hospitalization
timeFrame: one year after implantation
Secondary outcomes:
measure: Grade of Mitral Regurgitation
timeFrame: one month and one year after implantation
measure: Functional status
timeFrame: one month and one year after implantation
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
name: Malte Kelm, Prof.
role: STUDY_CHAIR
affiliation: Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
name: Patrick Horn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
name: Jafer Haschemi, MD
role: PRINCIPAL_INVESTIGATOR
References: