NCT03634072 (TOFandPVR) is a NA clinical trial of PVR in Tetralogy of Fallot, sponsored by Children's Hospital of Philadelphia.

Who is sponsoring NCT03634072?

NCT03634072 is sponsored by Children's Hospital of Philadelphia.

What drugs are being tested in NCT03634072?

Interventions in NCT03634072: PVR.

What condition does NCT03634072 study?

NCT03634072 studies Tetralogy of Fallot.

Is NCT03634072 still recruiting?

NCT03634072 is currently terminated. Last updated 6 October 2023.

Are results published for NCT03634072?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-06 · How we verify

NCT03634072: TOFandPVR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -

Terminated NA Results posted Last updated 6 October 2023

What this trial tests

NA trial testing PVR in Tetralogy of Fallot in 1 participant. Terminated before completion.

Timeline

6 July 2018

Primary endpoint
16 January 2021

16 January 2021

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1
Start date	6 July 2018
Primary completion	16 January 2021
Estimated completion	16 January 2021
Sites	6 locations across United States

Drugs / interventions tested

Conditions studied

Tetralogy of Fallot — all drugs for Tetralogy of Fallot →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 13 to 21, any sex, with Tetralogy of Fallot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Randomized to PVR Via Catheter or Surgery Primary · 2-3 years

Participants will be randomized by computer by the statistician at the Data Coordinating Center (DCC) at Northwestern University (NU) who will maintain the schedule; this will be a 2:1 randomization of PVR to no-PVR. There will be no blinding and the assignment will not be concealed from the investigators. There will be no stratifications within each group.

Group	Value	95% CI
PVR Arm	0

Sponsor's own description

Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary regurgitation (PR) which cause RV enlargement with right heart failure, diminished biventricular function, ventricular arrhythmia, sudden death and decreased exercise performance over time. Pulmonary valve replacement (PVR) has been thought to ameliorate these complications but the timing of replacement has yet to be determined with equipoise at the moment in this decision making process. As nearly all studies in this regard are retrospective with much less data in pediatric TOF than adults, this pilot trial sets the stage to create a prospective randomized trial in the teenage years.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Tetralogy of Fallot

Currently open trials in the same condition.

NCT06282926 — Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD · active not recruiting
NCT05809310 — Effects Branch PA Stenting d-TGA, ToF and TA · NA · recruiting
NCT04713657 — Beta-blocker Administration for Cardiomyocyte Division · Phase 1 · recruiting
NCT04106479 — NIRS in Congenital Heart Defects - Correlation With Echocardiography · recruiting
NCT04084132 — Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation · NA · recruiting

Other Children's Hospital of Philadelphia trials

Trials by the same sponsor.

NCT07023380 — EoE Food Test Pilot Study · NA · not yet recruiting
NCT06693752 — CEUS Evaluation of Hydrocephalus in Neonates and Infants · Phase 2 · recruiting
NCT07425691 — SPACE for Youth With Chronic Pain · recruiting
NCT07444528 — Upper Airway Ultrasound to Predict Difficult Laryngoscopy in Neonates and Infants · enrolling by invitation
NCT07321327 — Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions: Aim 2 · NA · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03634072 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Philadelphia
Last refreshed: 6 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03634072.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing