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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.
Patients will be randomized and proceed to one of two study arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA 1st Half of lesion | Experimental | 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 If Wenckebach behavior still persists, the patient will be withdrawn from the study. |
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| CA 2nd Half of Lesion | Experimental | 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 If Wenckebach behavior still persists, the patient will be withdrawn from the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pace During 1st Half of Lesion | Procedure |
| ||
| Pace During 2nd Half of Lesion |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Aizer, MD | New York University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30067488 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Procedure |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |