Evaluating heart tissue damage from different ablation techniques using MRI
Evaluation of Ablation Lesions Using Cardiovascular Magnetic Resonance Imaging
This study is testing different heart treatment methods for atrial fibrillation to see how they affect heart tissue damage and patient well-being using advanced imaging techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | R&D Cardiologie Academic / other |
| Locations | 1 site (Nieuwegein) |
| Trial ID | NCT05432024 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of various ablation techniques for atrial fibrillation by using cardiovascular magnetic resonance imaging (CMR) to evaluate the characteristics of ablation lesions. It will compare radiofrequency ablation, ultra-low temperature cryo ablation, and pulsed field ablation to determine their impact on arrhythmia recurrence and patient quality of life. The study seeks to provide a non-invasive alternative to traditional methods of assessing ablation lesions, which typically require invasive procedures. By analyzing the imaging results, the study hopes to improve the understanding of how different ablation techniques affect patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with paroxysmal or persistent atrial fibrillation scheduled for catheter ablation using specific techniques.
Not a fit: Patients with known allergies to gadolinium, contraindications for MRI, or prior interventions in the left atrium may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment of ablation techniques, potentially reducing arrhythmia recurrence and enhancing patient quality of life.
How similar studies have performed: While the use of CMR imaging for evaluating ablation lesions is a novel approach, similar studies have shown promise in improving patient outcomes through advanced imaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age ≥18 years old) * Paroxysmal or persistent atrial fibrillation, meeting criteria of the 2020 European Society of Cardiology Guidelines for diagnosis and management of atrial fibrillation * Patients scheduled to undergo catheter ablation for cardiac arrhythmia using one of the following techniques: Radiofrequency ablation (High power, short duration), Ultra-low temperature cryo ablation, or Pulsed field ablation Exclusion Criteria: * Known (or suspected) allergic reaction to gadolinium * Contraindications for MRI (such as claustrophobia, certain implants, devices, high body mass index). * Pregnancy or breastfeeding * Prior intervention in the left atrium (ablation or surgery)
Where this trial is running
Nieuwegein
- St. Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
Study contacts
- Principal investigator: Lucas VA Boersma, MD, PhD — St. Antonius Hospital
- Study coordinator: Lucas VA Boersma, MD, PhD
- Email: l.boersma@antoniusziekenhuis.nl
- Phone: 0883200900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.