Atrial Fibrillation, Catheter Ablation
Conditions
Brief summary
Multicenter 1:1 randomized study. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI \> 6 or AI \> 500 on the anterior aspect of pulmonary veins and power 25 W guided by LSI \>5 or AI \>350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).
Detailed description
Multicenter 1:1 randomized study: Hospital Universitario La Paz, Madrid; Hospital Clínico Universitario San Carlos, Madrid; Hospital Clínico y Provincial de Barcelona, Barcelona; Complejo Hospitalario de Navarra, Pamplona; Hospital Clínico Universitario de Valladolid; Hospital Clínico Universitario de Albacete; Hospital Clínico Universitario de Alicante; Hospital Universitario Virgen de las Nieves, Granada; Hospital La Fe, Valencia; Hospital Clínico de Valencia; Hospital Universitario Juan Ramón Jiménez, Huelva; Hospital de la Ribera, Alzira, Valencia. España. Spain. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI \> 6 or AI \> 500 on the anterior aspect of pulmonary veins and power 25-40 W guided by LSI \>5 or AI \>350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction). Subestudy: asymptomatic cerebral lesions detected by 1,5 T MRI \<72 h after ablation. Not all centers participate in the subestydy. However, if the center participates, all patients in both ablation groups will be included in the subestudy.
Interventions
OTHERHigh-power and short-duration radiofrequency ablatio (70 W / 9-10 s)
Pulmonary veins electrical isolation: high-power and short-duration ablation
OTHERLow-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values
Pulmonary veins electrical isolation: low-power ablation.
OTHEREsophageal endoscopy
Esophageal endoscopy to detect postablation esophageal thermal lesions.
DIAGNOSTIC_TESTDaily 30-seconds ECG
Transtelephonic daily 30-seconds single lead electrocardiogram
Sponsors
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Paroxysmal or persistent atrial fibrillation. * Currently accepted class I or II indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs. * Age \> 18 years. * Acceptance of informed consent.
Exclusion criteria
* Previous pulmonary veins ablation of any type. * Permanent atrial fibrillation or long-standing persistent AF (\>1 year). * Heart surgery \<3 months before ablation. * Coronary revascularization of any type \<3 months before ablation. * Myocardial infarction or acute coronary syndrome \< 3 months before ablation. * Stroke or transient cerebral ischaemic attack \< 3 months before ablation. * Persistent left atrial thrombus. * Contraindication for anticoagulation. * Absolute indication of double antiplatelet drugs. * Complex congenital heart disease, corrected or not. * Any clinical situation absolutely precluding an interventional procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: incidence of esophageal thermal lesions | 24 hours after ablation (permissible up to 72 hours after ablation) | Incidence of thermal esophageal lesions evaluated by endoscopy |
| Efficacy: recurrence of atrial arrhythmias | 1 year | Recurrences of any atrial arrhythmias \>30 seconds during 1-year follow-up evaluated by daily transtelephonic ECG transmissions (at least 1 ECG/day and additional transmissions whenever the patient perceives arrhythmia-related symptoms). |
| Total radiofrequency time | during ablation procedure | Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction). |
Countries
Spain
Outcome results
None listed