Atrial Fibrillation - Symptomatic
Conditions
Brief summary
This is a prospective, randomized (1:1), pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia (AF/AT) recurrence requiring repeat ablation following a single prior PVI procedure for AF.
Interventions
PROCEDUREDual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas
Re-PVI
PROCEDURECF-guided RFC: Re-PVI and substrate modification of low voltage areas
Re-PVI
Sponsors
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
* Patients with symptomatic non-valvular AF or AT recurrences despite of one previous PVI (+/- cavotricuspid isthmus ablation) catheter ablation for AF. Age 18-85 years Willing and able to comply with the study protocol Willing and able to operate a device for rhythm monitoring
Exclusion criteria
* Patients with contraindications to catheter ablation or inability to provide informed consent Patients who underwent PVI + (ablation of additional RA/LA substrates/areas) Patients who did not undergo PVI before Patients who underwent more than one prior PVI/Re-PVI Patients with left atrial size \> 55mm Patients with longstanding persistent AF \> 12 months duration Prior surgical AF ablation Contraindications for repeat ablation Prior implantable loop recorder History of mitral valve surgery Severe mitral valve regurgitation Inability to be treated with oral anticoagulation Presence of intracardiac thrombi Chronic obstructive pulmonary disease or Asthma treated with long acting bronchodilatators Obstructive sleep apnea syndrome requiring CPAP mask ventilation 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 |
|---|---|---|
| Primary Endpoint | Within the study duration of 1 Year | Complete re-pulmonary vein isolation (re-PVI), Bidirectional conduction block across linear lesions, Complete substrate elimination (defined as: voltage abatement and/or loss of capture). |
Countries
Germany
Contacts
CONTACTJulian Chun, Professor
CONTACTBoris Schmidt, Professor
PRINCIPAL_INVESTIGATORJulian Chun, Professor
MVZ CCB Germany
Outcome results
None listed