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

Study Overview
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Brief Summary
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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
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Patients will be randomized and proceed to one of two study arms: 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 If Wenckebach behavior still persists, the patient will be withdrawn from the study. 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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Pace During 1st Half of Lesion
* Procedure: Pace During 2nd Half of Lesion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CA 1st Half of lesion<br>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. | Procedure: Pace During 1st Half of Lesion<br> <br> |
| Experimental: CA 2nd Half of Lesion<br>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. | Procedure: Pace During 2nd Half of Lesion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior 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 |  | 20 Seconds | 
| Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary |  | 20 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 Right inferior pulmonary vein |  | 20 Seconds | 
| 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 Left pulmonary vein carina |  | 30 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 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 Middle CTI |  | 30 Seconds | 
| Percentage of time spent above CF 10 grams between paced and non-paced lesions at Posterior CTI |  | 30 Seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation, atrial fibrillation