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Treatment for Tricuspid Regurgitation (TANDEM II Trial)

N/A
Recruiting
Research Sponsored by CroiValve Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days
Awards & highlights

Summary

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Eligible Conditions
  • Tricuspid Valve Disease
  • Tricuspid Regurgitation
  • Heart Valve Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from device or procedure related MAEs

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)

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Who is running the clinical trial?

CroiValve LimitedLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
~9 spots leftby Apr 2025
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