The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Pace During 2nd Half of Lesion; Procedure: Pace During 1st Half of Lesion

• Registration Number: NCT02766712
• Lead Sponsor: NYU Langone Health

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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-10
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CA 2nd Half of Lesion	Pace During 2nd Half of Lesion	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.
CA 1st Half of lesion	Pace During 1st Half of Lesion	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.

Primary Outcome Measures

Name	Time	Method
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Anterior CTI	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right middle pulmonary vein	20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left middle pulmonary vein	20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right pulmonary vein carina	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Middle CTI	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Posterior CTI	30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left pulmonary vein carina	30 Seconds

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States