High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study.
- Conditions
- Cardiac ArrhythmiaEsophagus InjuryAtrial TachycardiaAtrial Fibrillation
- Interventions
- Other: High-power pulmonary veins ablation.Other: Conventional LSI/AI-guided pulmonary veins ablation.Diagnostic Test: Esophageal endoscopyOther: Esophageal temperature monitoring
- Registration Number
- NCT04162249
- Lead Sponsor
- Hospital Universitario La Paz
- Brief Summary
The POWER FAST I pilot study is a unicentric, observational, non-randomized controlled clinical study. In the control group pulmonary veins isolation was performded in consecutive patients with irrigated radiofrequency cateters without contact force-sensing capabilities and using conventional low-power and long-duration radiofrequency parameters (20-30 W, 30-60 s) under continuous intracardiac-echo image and esophageal temperature monitoring. The study group consist of consecutive patients distributed in three succesive subgroups. In the study group radiofrequency ablation was performed using a point-by-point technique with contact-force catheters with different high-power and short-duration parameters:
* Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall).
* Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g.
* Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g.
The safety endpoint was evaluated with systematic esophageal endoscopy performed \<72 h after the index procedure. The efficacy endpoint was evaluated:
* during the ablation procedure: acute procedural efficacy, firts-pass isolation of ipsilateral pulmonary veins, total radiofrequency and procedural time, acute reconnections and dormant conduction,
* during the follow-up: any atrial tachycardias documented and longer than 30 s were considered recurrences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF.
- Informed consent.
- Previous surgical or catheter-based PVI.
- Stroke or acute coronary syndrome <6 months before ablation.
- Terminal comorbidities.
- Frailty, or clinical instability.
- Absolute contraindication for oral anticoagulation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High-power and short-duration ablation Esophageal endoscopy Pulmonary veins ablation. * Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall). * Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g. * Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g. Intracardiac echo was not used. Esophageal temperature probes were used only in 6 patients in the subgroup 50W. Conventional ablation (CONTROL GROUP) Esophageal endoscopy Pulmonary veins ablation. * Anterior aspect: power 30 W, catheter dragging (30 s per point). * Posterior aspect: point-by-point ablation using 30 W/30 s applications. If esophageal temperature measured with two independent esophageal probes exceeded 49 ºC radiofrequency settings were modified to 20 W/ 60 s and the number of radiofrequency applications minimized in areas with esophageal temperature rise. Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring. High-power and short-duration ablation High-power pulmonary veins ablation. Pulmonary veins ablation. * Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall). * Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g. * Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g. Intracardiac echo was not used. Esophageal temperature probes were used only in 6 patients in the subgroup 50W. Conventional ablation (CONTROL GROUP) Conventional LSI/AI-guided pulmonary veins ablation. Pulmonary veins ablation. * Anterior aspect: power 30 W, catheter dragging (30 s per point). * Posterior aspect: point-by-point ablation using 30 W/30 s applications. If esophageal temperature measured with two independent esophageal probes exceeded 49 ºC radiofrequency settings were modified to 20 W/ 60 s and the number of radiofrequency applications minimized in areas with esophageal temperature rise. Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring. Conventional ablation (CONTROL GROUP) Esophageal temperature monitoring Pulmonary veins ablation. * Anterior aspect: power 30 W, catheter dragging (30 s per point). * Posterior aspect: point-by-point ablation using 30 W/30 s applications. If esophageal temperature measured with two independent esophageal probes exceeded 49 ºC radiofrequency settings were modified to 20 W/ 60 s and the number of radiofrequency applications minimized in areas with esophageal temperature rise. Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring.
- Primary Outcome Measures
Name Time Method Clinical feasibility (systematic use of the high-power and short-duration technique) Intraprocedural. Feasibility of the high-power and short-duration radiofrequency technique.
1-year efficacy One year Recurrence of atrial arrhythmias \>30 seconds
Incidence of complications < 72 hours after ablation. Incidence of esophageal thermal lesiones.
Acute efficacy Intraprocedural Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.
- Secondary Outcome Measures
Name Time Method Total radiofrequency time Intraprocedural Total radiofrequency time needed for definitive isolation of all pulmonary veins
Trial Locations
- Locations (1)
University Hospital La Paz, Department of Cardiology
🇪🇸Madrid, Spain