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

Medical University of Lublin30 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation

Interventions

RF ablation of atrial fibrillationOTHER

Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Lublin

Lublin, Poland

Outcomes

Primary Outcomes

Procedure time:

Total procedure time (needle to needle time).

Time frame: procedure

Secondary Outcomes

Left atrial dwelling time

time of left atrium instrumentation

Time frame: transeptal access to removal of a catheter and a sheath

Voltage mapping time

time needed to perform 3D electroanatomical map and high density voltage mapping of left atrium.

Time frame: procedure

Total RF time

time of all performed radiofrequency (RF) applications

Time frame: procedure

Total number of RF applications

number of all RF applications performed during a procedure

Time frame: procedure

X-Ray time

the total time of fluoroscopy

Time frame: procedure

Complications

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 \[yes/no\],

Data from ClinicalTrials.gov

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