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Clinical Trial 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.


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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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


Related Conditions & MeSH terms


NCT number NCT02766712
Study type Interventional
Source NYU Langone Health
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date May 2, 2017

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