Atrial Fibrillation
Conditions
Keywords
catheter ablation
Brief summary
The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation. The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation. After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification. After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) \< 0.5mV. Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance). The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting \> 30 seconds between day 91 and 365 after the index procedure.
Interventions
PROCEDURECatheter ablation using irrigated radiofrequency current ablation or cryothermal energy
Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.
Sponsors
Medtronic
CRO Kottmann
Cardioangiologisches Centrum Bethanien
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines. * Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter * Age 18-85 years. * Left atrial size \< 55mm. * Left ventricular ejection fraction ≥ 45%. * Patient is able to provide informed consent and is willing to comply with the study protocol.
Exclusion criteria
* Contraindications for repeat ablation * Reconnected pulmonary veins according to mapping results with a spiral mapping catheter * Minimal diameter of LAA neck ≥25mm * History of mitral valve surgery * Severe mitral valve regurgitation * Inability to be treated with oral anticoagulation * Presence of intracardiac thrombi * Chronic obstructive pulmonary disease treated with long acting bronchodilatators * Asthma * Obstructive sleep apnea syndrome * Pregnancy * Participation in other clinical studies * Unwilling to follow the study protocol and to attend follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia Recurrence | Day 91-365 after index ablation | Freedom from AF/AT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of periprocedural complications | day 0 - day 365 | Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding |
| Number of electrical cardioversions and hospitalizations | day0 - day 365 | Number of electrical cardioversions and hospitalizations |
Countries
Germany
Outcome results
None listed