High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: RF ablation of atrial fibrillation

• Registration Number: NCT04250181
• Lead Sponsor: Medical University of Lublin

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-11-15
• Primary Completion: 2020-01-20
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Status Verified: 2020-02
• Study Completion: 2020-02-08
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High RF 50W (50 Watts)	RF ablation of atrial fibrillation	ablation with RF power of 50 watts (50W)
Standard RF	RF ablation of atrial fibrillation	ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall
High RF 40W (40 Watts)	RF ablation of atrial fibrillation	ablation with RF power of 40 watts (40W)

Primary Outcome Measures

Name	Time	Method
Procedure time:	procedure	Total procedure time (needle to needle time).

Secondary Outcome Measures

Name	Time	Method
Voltage mapping time	procedure	time needed to perform 3D electroanatomical map and high density voltage mapping of left atrium.
Total number of RF applications	procedure	number of all RF applications performed during a procedure
X-Ray time	procedure	the total time of fluoroscopy
Complications	12 months	both procedure-related complications and all complications in 12 moths follow-up as follows: Cardiac tamponade/perforation \[yes/no\], Stroke/TIA (Transient ischemic attack) \[yes/no\], Oesophageal injury (perforation/fistula) \[yes/no\], Death (procedural related, one year follow up) \[yes/no\], Stem pops \[yes/no\], Catheter char \[yes/no\], Phrenic nerve paralysis \[yes/no\], PV stenosis requiring intervention \[yes/no\], Gastrointestinal bleeding or gastrointestinal complaints \[yes/no\], Need for periprocedural pacemaker implantation \[yes/no\], Vascular access complication which required intervention \[yes/no\], Vascular access complication which not required intervention \[yes/no\],
Number of stopped RF applications as a result of pain complained by a patient	procedure	the surrogate for assessment of the painfulness of the procedure
Left atrial dwelling time	transeptal access to removal of a catheter and a sheath	time of left atrium instrumentation
Total RF time	procedure	time of all performed radiofrequency (RF) applications
Follow-up-30s	procedure	absence any arrhythmia recurrence (AR) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL) lasting longer than 30 second

Trial Locations

Locations (1)

Medical University of Lublin; 🇵🇱 Lublin, Poland