Clinical Trials Directory

Trials / Completed

CompletedNCT04250181

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

HPvSP-AF Trail: Is High RF Energy Ablation of Atrial Fibrillation Fast, Safe, Less Painful and Effective - a Propensity Score Matched Analysis of 30/25W, 40W and 50W RF Energy Settings

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Medical University of Lublin · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERRF ablation of atrial fibrillationComparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

Timeline

Start date
2019-11-15
Primary completion
2020-01-20
Completion
2020-02-08
First posted
2020-01-31
Last updated
2020-02-18

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT04250181. Inclusion in this directory is not an endorsement.