Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population (LEAFLET I)

Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population

To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Mitral Regurgitation; Valvular Heart Disease
• Intervention / Treatment: Device: Transcatheter mitral valve edge-to-edge repair (M-TEER)

Detailed Description

In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jörg Hausleiter, Prof. Dr.; Phone Number: +4989440072361; Email: Joerg.Hausleiter@med.uni-muenchen.de
• Study Contact Backup: Name: Ludwig Weckbach, PD Dr.; Email: Ludwig.Weckbach@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • LMU Klinikum
      • Contact: Jörg Hausleiter, Prof. Dr.; Phone Number: +4989440072361; Email: Joerg.Hausleiter@med.uni-muenchen.de
      • Contact: Ludwig Weckbach, PD Dr.; Email: Ludwig.Weckbach@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age equal or above 18 years
• Written consent
• Heart Team recommends M-TEER

Exclusion Criteria:

• Mitral Stenosis (MV mean PG > 5 mmHg)
• Cardiogenic shock or hemodynamic instability at the time of intervention
• Active endocarditis
• Participant in another interventional cardiology study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MitraClip	Device: Transcatheter mitral valve edge-to-edge repair (M-TEER); M-TEER is performed via a transfemoral venous approach. After puncture of the interatrial septum the mitral valve is repaired using either the PASCAL or MitraClip device.
Active Comparator: PASCAL	Device: Transcatheter mitral valve edge-to-edge repair (M-TEER); M-TEER is performed via a transfemoral venous approach. After puncture of the interatrial septum the mitral valve is repaired using either the PASCAL or MitraClip device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprocedural residual MR measured by 3D EROA	residual MR measured by 3D EROA as continuous parameter	During the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in MR EROA	Reduction in MR EROA from baseline to postprocedural (relative and absolut value)	During the index procedure
Comparing EROA in complex vs. non-complex patients	Evaluation according to EROA reduction	During the index procedure
Postprocedural MV opening area	Postprocedural MV opening area (planimetric)	During the index procedure
Postprocedural MV inflow gradient	Mean pressure gradient and pressure halftime	During the index procedure
SLDA	Single Leaflet Device Attachment	During the index procedure, at 30-day follow-up and at 1-year follow-up
Conversion to surgery or re-imaging of the MV	Conversion to surgery (urgently or elective) or re-imaging of the MV	During the index procedure, at 30-day follow-up and at 1-year follow-up
Stratification by MR etiology	Primary vs. Secondary MR	During the index procedure, at 30-day follow-up and at 1-year follow-up
Combined endpoint of mortality, repeat MV intervention or HHF	Assessed at 30-days and 1-year	During the index procedure, at 30-day follow-up and at 1-year follow-up
Quality of Life	Measured using the KCCQ Score	At 30-day follow-up and at 1-year follow-up
Exertional dyspnea	NYHA functional class	At 30-day follow-up and at 1-year follow-up

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Jörg Hausleiter, Prof. Dr., LMU Klinikum; Principal Investigator: Ludwig Weckbach, PD Dr., LMU Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Mitral Regurgitation; MitraClip; PASCAL; TEER
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Mitral Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: LEAFLET I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No