Rhythm MonitoringNCT06758895
Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter
An observational study of Rhythm Monitoring, run by Assiut University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhythm Monitoring
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- LA thrombus on TEE or CMR.
- Contraindications to CMR.
- Contraindications to Gd-based contrast.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
evaluate the impact of various features in CMR on the mid-term/long-term success rate of rhythm control for paroxysmal atrial fibrillation/flutter .
Read the 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
- Conditions
- Rhythm Monitoring
- Keywords
- CMR predictors of rhythm control in patient with AFibirilation/flutter
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
parameters for safe ablation
- Ablation arm: Predictors of esophageal thermal injury (ETI).
- Arterial embolic events in both arms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhythm MonitoringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Ashraf Abd El-Naeem Sayed, Assiut University
- Investigators
- Salah EL-dein Sayed Ata, Professor of cardiology, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758895
- Sponsor's protocol ID
- CMR in rythm control
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Calkins H et al. Circ Arrhythm Electrophysiol. 2009
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter
- ClinicalTrials.gov ID
- NCT06758895
- Acronym / sponsor ID
- CMR in rythm control
- Conditions
- Rhythm Monitoring
- Keywords
- CMR predictors of rhythm control in patient with AFibirilation/flutter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- LA thrombus on TEE or CMR.
- Contraindications to CMR.
- Contraindications to Gd-based contrast.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
parameters for safe ablation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background1. Calkins H et al. Circ Arrhythm Electrophysiol. 2009
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salah EL-dein Sayed Ata, Professor of cardiology study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhythm Monitoring, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryem Ashraf Abd El-Naeem Sayed, Resident Doctor (+2001097400995, reemy.rooma77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurence in patient with AF or flutter after pharmacological or interventional rythm control (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.