Effects Branch PA Stenting d-TGA, ToF and TA

NCT05809310 | Recruiting

• 1 other identifier: NL81160
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

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\[s\] it aims to answer are: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions. Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions. Researchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)

Conditions

Transposition of Great Vessels; Tetralogy of Fallot; Truncus Arteriosus; Pulmonary Artery Stenosis Supravalvular Congenital; Stent Stenosis; Right Ventricular Dysfunction; Congenital Heart Disease

Keywords

Exercise capacity

Outcome Measures

Primary Outcomes (1)

• Change from baseline VO2max as percentage of predicted at 6 months as indication of exercise capacity

  using cardiopulmonary exercise test on a treadmill

  change between baseline and 6 months follow-up

Secondary Outcomes (18)

• Technical success using invasive right ventricular and pulmonary artery pressures and gradients

  after the intervention, an average of 1 month after baseline

• Peak workload (W)

  at baseline, 6 months follow-up and 2-4 years follow-up

• Peak workload (% predicted)

  at baseline, 6 months follow-up and 2-4 years follow-up

• O2 pulse (ml)

  at baseline, 6 months follow-up and 2-4 years follow-up

• O2 pulse (% predicted)

  at baseline, 6 months follow-up and 2-4 years follow-up

Study Arms (2)

Interventional group

EXPERIMENTAL

Percutaneous intervention for PA stenosis

Procedure: Percutaneous intervention (stent) for PA stenosis

Control group

NO INTERVENTION

Conservative management (percutaneous intervention for PA stenosis 6 months postponed)

Interventions

Percutaneous intervention (stent) for PA stenosis PROCEDURE

Percutaneous intervention (stent placement) in one or both of the branch pulmonary arteries

Interventional group

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch Heart Foundation: collaborator
• Hartekind: collaborator
• Erasmus Medical Center: collaborator
• Leiden University Medical Center: collaborator
• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): collaborator

Study Sites (4)

Amsterdam University Medical Center location AMC

Amsterdam, 1105 AZ, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, 3015 CN, Netherlands

NOT YET RECRUITING

UMC Utrecht/WKZ

Utrecht, 3584 CX, Netherlands

RECRUITING

Related Publications (1)

• Joosen RS, Voskuil M, Krasemann TB, Blom NA, Krings GJ, Breur JMPJ; Outreach consortium. The effects of percutaneous branch pulmonary artery interventions in biventricular congenital heart disease: study protocol for a randomized controlled Dutch multicenter interventional trial. Trials. 2024 Sep 3;25(1):581. doi: 10.1186/s13063-024-08436-8.

  PMID: 39227910 DERIVED

MeSH Terms

Conditions

Transposition of Great Vessels; Tetralogy of Fallot; Truncus Arteriosus, Persistent; Ventricular Dysfunction, Right; Heart Defects, Congenital

Interventions

Stents

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortopulmonary Septal Defect; Heart Septal Defects; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Hans Breur, MD, PhD

CONTACT

+31 88 75 754 59; h.breur@umcutrecht.nl

Renée Joosen, MSc

CONTACT

r.s.joosen-2@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 12, 2023
• Study Start: April 18, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)