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Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) (SCOUT-II)

M

Mitralign

Status

Unknown

Conditions

Tricuspid Valve Insufficiency
Chronic Symptomatic Functional Tricuspid Regurgitation
Heart Valve Disease

Treatments

Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03225612
CLPR-011

Details and patient eligibility

About

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.

Full description

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
  • ≥18 and ≤85 years old;
  • NYHA II, III, or ambulatory IV;
  • Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
  • patient is at high risk for open heart valve surgery
  • LVEF ≥35%
  • Tricuspid valve annular diameter ≤55 mm (or 29 mm/m^2)

Exclusion criteria

  • Pregnant or lactating female;
  • Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
  • Previous tricuspid valve repair or replacement;
  • Severe coronary artery disease;
  • MI or known unstable angina within the 30-days prior to the index procedure;
  • Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;
  • Chronic oral steroid use (≥6 months);
  • Life expectancy of less than 12-months

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Open Label
Experimental group
Description:
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.
Treatment:
Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Trial contacts and locations

11

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Central trial contact

Gisella Blanchette; Patricia Keating

Data sourced from clinicaltrials.gov

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