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

NCT06758895 | Not Yet Recruiting

• 1 other identifier: CMR in rythm control
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 .

Conditions

Rhythm Monitoring

Keywords

CMR predictors of rhythm control in patient with AFibirilation/flutter

Outcome Measures

Primary Outcomes (1)

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

  * 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.

  Baseline

Secondary Outcomes (1)

• parameters for safe ablation

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the previously reported antiarrhythmic drug efficacy of 52% in maintaining sinus rhythm: * For Wilcoxon-Mann-Whitney test for difference in 2 group means: assuming an alpha error probability of 0.05, a study power of 60-70%, and a 1:1 ratio of successful rhythm control vs atrial fibrillation/flutter recurrence, a total sample size of 86-106 would be needed (43-53 for each arm). \[calculated by G\*Power software v.3.1.9.7\] * To be able to build multivariable logistic regression models including, e.g., 4-5 predictor variables, a reasonable sample size would be 80-100 patients. * Patient enrollment will continue until the projected sample size is satisfied or until 24 months have lapsed, whichever comes first.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Univeristy Heart Hospital

Asyut, Egypt

Location

Related Publications (1)

• 1. Calkins H et al. Circ Arrhythm Electrophysiol. 2009

  BACKGROUND

Study Officials

• Salah EL-dein Sayed Ata, Professor of cardiology

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Maryem Ashraf Abd El-Naeem Sayed, Resident Doctor

CONTACT

+2001097400995; reemy.rooma77@gmail.com

Amr EL-Badry Ibrahim, Lecture of cardiology

CONTACT

+2001060701601; aelbadry@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor at Assiut University Heart Hospital

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

EG (1)