Clinical trial NCT02766712: The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation
Official title: The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: catheter ablation
atrial fibrillation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a two arm randomized, paired prospective study comparing the percentage of time spent above Contact Force (CF), Force Time Integral (FTI) and other lesion parameters in the setting of pacing versus non-pacing. This study is designed to compare the percentage of time spent above CF 10 grams between paced and non-paced lesions at 15 pre-determined lesion locations.

Detailed description: Patients will be randomized and proceed to one of two study arms:

1. Pacing during first half of lesions: During each of the 15 pre-specified lesions, pacing will be initiated at a 500ms cycle length from a catheter in the coronary sinus or right ventricle prior to the start of the lesion. Pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). In the event that Wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. In the event that Wenckebach behavior persists, the cycle length will be adjusted to 600ms. In the event that Weckebach behavior continues, the pacing catheter will be moved to the right ventricle, which and pacing will be performed at a 500ms cycle length. If Wenckebach behavior still persists, the patient will be withdrawn from the study.
2. Pacing during second half of lesions: During each of the 15 pre-specified lesions, pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). In the event that Wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. In the event that Wenckebach behavior persists, the cycle length will be adjusted to 600ms. In the event that Wenckebach behavior persists, the pacing catheter will be moved to the right ventricle and pacing will be performed at a 500ms cycle length. If Wenckebach behavior still persists, the patient will be withdrawn from the study.

Eligibility criteria: Inclusion Criteria:

* Patients with AF scheduled for AF ablation with planned pulmonary vein isolation
* Presenting in normal sinus rhythm (NSR) prior to lesion delivery

Exclusion Criteria:

* Previous radiofrequency ablation
* Previous thoracotomy-type AF ablation (MAZE or similar technique)
* In AF prior to lesion delivery
* Evidence of left atrial scarring on voltage map
* Resting heart rate \> 90 bpm

Primary outcomes:
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein
timeFrame: 20 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left middle pulmonary vein
timeFrame: 20 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein
timeFrame: 20 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary
timeFrame: 20 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right middle pulmonary vein
timeFrame: 20 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein
timeFrame: 20 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left pulmonary vein carina
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right pulmonary vein carina
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Anterior CTI
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Middle CTI
timeFrame: 30 Seconds
measure: Percentage of time spent above CF 10 grams between paced and non-paced lesions at Posterior CTI
timeFrame: 30 Seconds
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Anthony Aizer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aizer A, Cheng AV, Wu PB, Qiu JK, Barbhaiya CR, Fowler SJ, Bernstein SA, Park DS, Holmes DS, Chinitz LA. Pacing Mediated Heart Rate Acceleration Improves Catheter Stability and Enhances Markers for Lesion Delivery in Human Atria During Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2018 Apr;4(4):483-490. doi: 10.1016/j.jacep.2017.12.017. Epub 2018 Mar 1.