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

December 28, 2024 updated by: Maryam Ashraf Abd El-Naeem Sayed, Assiut University
evaluate the impact of various features in CMR on the mid-term/long-term success rate of rhythm control for paroxysmal atrial fibrillation/flutter .

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maryem Ashraf Abd El-Naeem Sayed, Resident Doctor
  • Phone Number: +2001097400995
  • Email: reemy.rooma77@gmail.com

Study Contact Backup

  • Name: Amr EL-Badry Ibrahim, Lecture of cardiology
  • Phone Number: +2001060701601
  • Email: aelbadry@aun.edu.eg

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut Univeristy Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parameters for safe ablation
Time Frame: Baseline
  • Ablation arm: Predictors of esophageal thermal injury (ETI).
  • Arterial embolic events in both arms.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Salah EL-dein Sayed Ata, Professor of cardiology, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 28, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMR in rythm control

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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