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Search / Trial NCT07010510

Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by CMR

Launched by ASSIUT UNIVERSITY · May 30, 2025

Trial Information

Current as of September 09, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at the health and quality of life in adults who have had surgery to repair Tetralogy of Fallot (TOF), a common heart condition present at birth. The goal is to understand how well these patients are doing functionally and to identify any heart rhythm problems they may have. Researchers will use various tests, including heart imaging and exercise assessments, to gather information about the participants' heart function and overall health. This study aims to help predict heart rhythm issues and determine if additional treatments are needed.

To participate, individuals must be at least 18 years old and have had surgery for TOF, either with a valve-sparing repair or a valved conduit. They should be attending follow-up appointments that include a special heart imaging test called cardiac magnetic resonance (CMR). However, individuals with certain other heart defects or conditions, or those who cannot undergo CMR for health reasons, will not be eligible. Participants can expect to undergo several evaluations over the course of a year, and their personal information will be kept confidential throughout the study.

Gender

ALL

Eligibility criteria

  • * Inclusion criteria:
  • Adult TOF patients who were referred for surgical repair of TOF either valve sparing repair (VSR) or valved conduit (stented valve conduits, freestyle valved conduits, bio-prosthesis, or homograft).
  • Adults (age ≥18 years) with repaired TOF.
  • Undergoing routine CMR for clinical follow-up.
  • Sinus rhythm or known history of ventricular arrhythmia.
  • * Exclusion criteria:
  • Confounding other congenital defects e.g. AV canal.
  • Significant aortic regurgitation or stenosis.
  • Significant mitral regurgitation.
  • Residual significant major aorto-pulmonary collaterals (MAPCAs).
  • Patients with contraindications to CMR (e.g., pacemakers, severe renal impairment, claustrophobic).
  • Poor-quality CMR images precluding strain analysis.

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported