Atrial Fibrillation, Atrial Tachycardia, Cardiac Arrhythmia, Esophagus Injury
Conditions
Keywords
Atrial fibrillation, Ablatión, High-power, Radiofrequency, Esophageal lesion
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.
Interventions
OTHERConventional LSI/AI-guided pulmonary veins ablation.
Conventional (low-power and long-duration) radiofrequency application.
OTHERHigh-power pulmonary veins ablation.
Experimental (high-power and short-duration) radiofrequency application.
OTHEREsophageal temperature monitoring
Two probes were simultaneously used: a deflectable one and a non-deflectable one.
DIAGNOSTIC_TESTEsophageal endoscopy
Esophageal endoscopy for acute detection of esophageal thermal lesions \<72 hours after ablation.
Sponsors
Hospital Universitario La Paz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF. * Informed consent.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical feasibility (systematic use of the high-power and short-duration technique) | Intraprocedural. | Feasibility of the high-power and short-duration radiofrequency technique. |
| 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. |
| 1-year efficacy | One year | Recurrence of atrial arrhythmias \>30 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total radiofrequency time | Intraprocedural | Total radiofrequency time needed for definitive isolation of all pulmonary veins |
Countries
Spain
Outcome results
None listed