High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients (HPvSP-AF)

Medical University of Lublin

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: RF ablation of atrial fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT04250181

HPvSP-AF ablation

Details and patient eligibility

About

High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.

Full description

Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation and is usually associated with a long procedural time and sensation of pain in conscious patients. Prolonged radiation exposure during the procedure puts the patient and the operator at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer ablation time.

High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side index (LSI) value has been associated with durability of pulmonary vein isolation (PVI) lesions.

We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior to standard approach regarding safety and effectiveness with shorten procedure time and being less painful for a patient.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic patients with non-valvular AF,
• aged:18-85, first procedure in left atrium,
• exclusion of thrombus in left atrium and left atrium appendage,
• left ventricle ejection fraction >55%

Exclusion criteria

• age below 18 or above 85 years,
• left ventricle ejection fraction<55%,
• previous procedure in left atrium,
• valvular AF

Trial design

30 participants in 3 patient groups

Standard RF

Description:

ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall

Treatment:

Other: RF ablation of atrial fibrillation

High RF 40W (40 Watts)

Description:

ablation with RF power of 40 watts (40W)

Treatment:

Other: RF ablation of atrial fibrillation

High RF 50W (50 Watts)

Description:

ablation with RF power of 50 watts (50W)

Treatment:

Other: RF ablation of atrial fibrillation