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)
Enter a location and click search to find clinical trials sorted by distance.
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