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NCT Number: NCT06758895

Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter

evaluate the impact of various features in CMR on the mid-term/long-term success rate of rhythm control for paroxysmal atrial fibrillation/flutter .

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Key information

Conditions

Rhythm Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut Univeristy Heart Hospital

Asyut, Egypt

About this study

  • Atrial fibrillation/flutter are widely prevalent.
  • Reported antiarrhythmic drug efficacy to restore & maintain sinus rhythm is 52% which is far from optimal.
  • On the other hand, 5-year arrhythmia-free survival after catheter ablation was previously reported to be 63%.
  • Therefore, there is a need for better characterization of the underlying atrial substrate, to improve treatment outcomes in terms of efficacy and safety

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18 years.
  • Patients undergoing successful cardioversion (pharmacologic or electric) for atrial fibrillation/flutter, OR symptomatic patients with paroxysmal atrial fibrillation/flutter scheduled for trans-catheter ablation.
  • Index cardioversion OR Index ablation procedure.

Exclusion criteria

  • LA thrombus on TEE or CMR.
  • Contraindications to CMR.
  • Contraindications to Gd-based contrast.

Treatment and study plan

Primary outcomes

  1. Recurence in patient with AF or flutter after pharmacological or interventional rythm control

    Time frame: Baseline

    • Non-invasive rhythm control arm: Predictors of atrial fibrillation recurrence within 6 months of cardioversion or the need for ≥2 cardioversions in the 1st year after initial cardioversion.
    • Ablation arm: Predictors of success rate (acute and mid term) of ablation on multivariable logistic regression analysis.

Secondary outcomes

  1. parameters for safe ablation

    Time frame: Baseline

    • Ablation arm: Predictors of esophageal thermal injury (ETI).
    • Arterial embolic events in both arms.

Study contacts

Contact information is provided by the study sponsor or research team.

Amr EL-Badry Ibrahim, Lecture of cardiology

CONTACT

[email protected]

+2001060701601

Maryem Ashraf Abd El-Naeem Sayed, Resident Doctor

CONTACT

[email protected]

+2001097400995

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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