Status:

RECRUITING

Effects Branch PA Stenting d-TGA, ToF and TA

Lead Sponsor:

UMC Utrecht

Collaborating Sponsors:

Dutch Heart Foundation

Hartekind

Conditions:

Transposition of Great Vessels

Tetralogy of Fallot

Eligibility:

All Genders

8+ years

Phase:

NA

Brief Summary

The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The main question...

Detailed Description

Rationale: Postoperative survival of patients with dextro transposition of the great arteries (d-TGA), Tetralogy of Fallot (ToF) and Truncus Arteriosus (TA) has increased over the last decades due to ...

Eligibility Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Patients with d-TGA post ASO, ToF or TA
  • ≥8 years

Exclusion Criteria:

One or more of the following inclusion criteria:

  • All class IIa indications for a branch PA intervention:

  • Persistent decreased RV function (based on gold standard CMR)

    • <18 years RVEF ≤55% (28)
    • ≥18 years RVEF<50% (29)
  • Progressive tricuspid regurgitation (TR) (≥moderate)

  • Isolated bifurcation stenosis:

    • Significant unilateral stenosis (≥50%)
    • Borderline bilateral PA stenosis (40-70%)
  • Unbalanced perfusion (≤35/65%)

  • RV/LV pressure ratio > 2/3 based on echocardiography

  • Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET)

    • <18 years VO2 peak <35 mL∙kg-1∙min-1 (boys) VO2 peak <30 mL∙kg-1∙min-1 (girls) (30)
    • ≥18 years VO2 peak <27 mL∙kg-1∙min-1 (men) VO2 peak <19 mL∙kg-1∙min-1 (women) (31)

Key Trial Info

Start Date :

April 18 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT05809310

Start Date

April 18 2023

End Date

December 31 2027

Last Update

March 30 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Amsterdam University Medical Center location AMC

Amsterdam, Netherlands, 1105 AZ

2

Leiden University Medical Center

Leiden, Netherlands, 2333 ZA

3

Erasmus Medical Center

Rotterdam, Netherlands, 3015 CN

4

UMC Utrecht/WKZ

Utrecht, Netherlands, 3584 CX