NCT02766712|CompletedDMC
The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation
PEP AF
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PEP AF
Sponsor study identifier
interventional
64
1 country
1
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2, 2017
Actual (reported)Study Completion
May 2, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
May 6, 2016
Actual (reported)May 10, 2016
Actual (reported)May 2, 2017
Actual (reported)May 2, 2017
Actual (reported)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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
New York University School of Medicine
New York, New York, 10016, United States
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.
Anthony Aizer, MD
New York University Medical School
64 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2016
First Posted
May 10, 2016
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation
Substrate Versus Trigger Ablation for Paroxysmal Atrial Fibrillation
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
Contact the study team to confirm eligibility.
Primary Completion
May 2, 2017
Actual (reported)Study Completion
May 2, 2017
Actual (reported)Last Updated
November 12, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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