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

Not yet recruiting

• Conditions: Rhythm Monitoring

• Registration Number: NCT06758895
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

* 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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study Start: 2025-01
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-01
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurence in patient with AF or flutter after pharmacological or interventional rythm control	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 Outcome Measures

Name	Time	Method
parameters for safe ablation	Baseline	* Ablation arm: Predictors of esophageal thermal injury (ETI).; * Arterial embolic events in both arms.

Trial Locations

Locations (1)

Assiut Univeristy Heart Hospital; 🇪🇬 Assiut, Egypt