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Device

Open Label for Tricuspid Regurgitation (SCOUT Trial)

N/A
Waitlist Available
Led By Rebecca Hahn, MD
Research Sponsored by Mitralign, Inc.
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 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Awards & highlights

Summary

The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR). The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

Eligible Conditions
  • Tricuspid Regurgitation
  • Valvular Heart Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Technical success at 30-days
Secondary study objectives
Heart failure
Secondary safety and performance endpoints mid-term and long-term

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Non-randomized, open label clinical study that intends to treat up to 30 subjects with the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) using standard of care techniques and services that are typically used for structural heart procedures.

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Who is running the clinical trial?

Mitralign, Inc.Lead Sponsor
3 Previous Clinical Trials
145 Total Patients Enrolled
Rebecca Hahn, MDPrincipal InvestigatorColumbia Unviersity Medical Center / New York-Presbyterian Hospital
1 Previous Clinical Trials
1,070 Total Patients Enrolled
Christopher Meduri, MD, MPHPrincipal InvestigatorPiedmont Healthcare
~3 spots leftby Sep 2025
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