CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02619396
NCT02619396N/ACompleted

Radiofrequency Power, Lesion Size Index and Oesophageal Temperature Alerts During Atrial Fibrillation Ablation: A Pilot Study

Oxford University Hospitals NHS Trust·interventional·Posted Dec 2, 2015·Updated Jul 8, 2020

In Brief

A clinical study evaluating Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, and 2 other interventions for Atrial Fibrillation. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Atrial fibrillation (AF) is a very common abnormal heart rhythm, triggered by rapid electrical activity originating from the pulmonary veins (PVs) that drain blood from the lungs back to the left atrium (LA). Ablation of the junction between the PVs and the LA, electrically isolating the veins from the heart, is the key to prevent AF. When using radiofrequency energy (RF), transmural lesions are required to achieve permanent pulmonary vein isolation (PVI). New technologies are currently available to predict the ablation lesion depth and to guide the duration of each application. However, deeper lesions mean a higher risk of overheating and damage of adjacent structures such as the esophagus that lies against the back wall of the LA. In order to minimize this risk, the investigators continuously monitor the temperature inside the esophagus during the procedure through a probe placed in the esophagus and they promptly terminate energy delivery in case of any esophageal temperature rises more than 39°C. To date, it is not known if a low power for a longer time is better than a high power for a shorter time when ablating on the LA posterior wall in order to create permanent scars without heating the esophagus. Therefore, the investigators plan to compare the incidence of esophageal temperature alerts and the success of the procedure with four different energy settings during ablation on the LA posterior wall.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2, 2015
Enrollment StartJan 1, 2016
Primary CompletionMar 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.6 years ago

Interventions

Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallprocedure

20 W RF power and target LSI = 4 on LA posterior wall

Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallprocedure

40 W RF power and target LSI = 4 on LA posterior wall

Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallprocedure

20 W RF power and target LSI = 5 on LA posterior wall

Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallprocedure

40 W RF power and target LSI = 5 on LA posterior wall