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Device

Open Label for Valvular Heart Disease (SCOUT-II Trial)

N/A
Waitlist Available
Led By Prof. Dr. med Joachim Schofer
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 change from baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Awards & highlights

Summary

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation. 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
  • Valvular Heart Disease
  • Tricuspid Regurgitation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of all-cause mortality at 30 days.
Secondary outcome measures
Adverse Events
Tricuspid valve structure
Echocardiographic variable: tenting area (maximum, any view)
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Non-randomized, open label clinical study that intends to treat up to 60 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.

Find a Location

Who is running the clinical trial?

CardioVascular Research Foundation, KoreaOTHER
106 Previous Clinical Trials
229,301 Total Patients Enrolled
Mitralign, Inc.Lead Sponsor
3 Previous Clinical Trials
115 Total Patients Enrolled
1 Trials studying Valvular Heart Disease
30 Patients Enrolled for Valvular Heart Disease
GenaeIndustry Sponsor
8 Previous Clinical Trials
2,219 Total Patients Enrolled
~7 spots leftby Sep 2025
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