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

Atrial Fibrillation Clinical Trial

— PEP AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766712
• Other study ID #: 16-00813
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2, 2017

Study information

• Verified date: November 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pace During 1st Half of Lesion

• Pace During 2nd Half of Lesion

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein		20 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left middle pulmonary vein		20 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein		20 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary		20 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right middle pulmonary vein		20 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein		20 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left pulmonary vein carina		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right pulmonary vein carina		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Anterior CTI		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Middle CTI		30 Seconds
Primary	Percentage of time spent above CF 10 grams between paced and non-paced lesions at Posterior CTI		30 Seconds