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New treatment option for Transposition of Great Vessels
Official title Effects Branch PA Stenting d-TGA, ToF and TA
ClinicalTrials.gov ID: NCT05809310
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join 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 likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Leiden, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Leiden, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.