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Device

MitraClip G4 System for Mitral Valve Regurgitation

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights

Summary

This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.

Eligible Conditions
  • Mitral Valve Regurgitation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Major Adverse Events (MAE) at 30 days
Percentage of Participants with MR Reduction to ≤2+ or less at 30 days
Other outcome measures
Difference Between 6 minutes walk distance (6MWD) at 30 days, 1 and 5 year
Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 30 days, 1, 2, 3, 4 and 5 year, higher score means a better outcome (0-100)
Difference Between New York Heart Association (NYHA) at Discharge, 30 days, 1, 2, 3, 4 and 5 years, higher class means a worse outcome (Class I to IV)
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: MitraClip G4 SystemExperimental Treatment1 Intervention
Percutaneous mitral valve repair using the MitraClip G4 system

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
752 Previous Clinical Trials
477,098 Total Patients Enrolled
Abbott Medical DevicesLead Sponsor
647 Previous Clinical Trials
407,470 Total Patients Enrolled
Kartik Sundareswaran, PhDStudy DirectorAbbott Structural Heart
5 Previous Clinical Trials
2,341 Total Patients Enrolled
~191 spots leftby Sep 2025
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