Ablation and Isolation for Persistent Atrial Fibrillation Treatment
Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
This study is testing a new two-step treatment for long-lasting atrial fibrillation to see if it works better than the standard method and helps patients need fewer medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06165510 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a hybrid approach combining convergent ablation with the LARIAT procedure against standard endocardial catheter ablation in patients suffering from long-standing persistent atrial fibrillation. The study involves a two-stage minimally invasive procedure where the first stage includes surgical ablation and left atrial appendage isolation, followed by endocardial catheter ablation to enhance treatment outcomes. Participants will be randomly assigned to one of the two treatment groups to assess safety and efficacy. The goal is to improve success rates and reduce the need for anti-arrhythmic medications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with persistent atrial fibrillation lasting over one year.
Not a fit: Patients with reversible causes of atrial fibrillation, significant valve disease, or prior cardiac surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient quality of life and reduce hospital readmission rates.
How similar studies have performed: While the approach is innovative, previous studies have shown mixed results with standard catheter ablation, indicating a need for improved methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years; \< 80 years * Persistent AF \> 1-year duration * Left atrium size \< 6cm * Pts should be able to provide written informed consent. Exclusion Criteria: * Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments. * Subject has a reversible cause of AF or transient AF * Subject is absent of LAA or if the LAA is previously surgically ligated * Subject has had previous cardiac surgery or abdominal surgery. * Subject has contraindication to anticoagulation. * Patients with hypertrophic cardiomyopathy. * Patients with significant valve disease. * Subject has had previous catheter or surgical ablation
Where this trial is running
London
- St Bartholomew's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Syed Ahsan — Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust
- Study coordinator: Syed Ahsan
- Email: syedahsan@nhs.net
- Phone: 020 7377 7000
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.