Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLMU Klinikum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age equal or above 18 years
Written consent
Heart Team recommends M-TEER
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcatheter mitral valve edge-to-edge repair (M-TEER)
DeviceM-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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: MitraClipActive comparator 1 intervention
Group B: PASCALActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postprocedural residual MR measured by 3D EROA
residual MR measured by 3D EROA as continuous parameter
Time frame
During the index procedureSecondary outcomes
1
Reduction in MR EROA
Reduction in MR EROA from baseline to postprocedural (relative and absolut value)
Time frame
During the index procedure2
Comparing EROA in complex vs. non-complex patients
Evaluation according to EROA reduction
Time frame
During the index procedure3
Postprocedural MV opening area
Postprocedural MV opening area (planimetric)
Time frame
During the index procedure4
Postprocedural MV inflow gradient
Mean pressure gradient and pressure halftime
Time frame
During the index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov