Skip to main content
OpenTrials
Completed

NCT Number: NCT02766712

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pace During 1st Half of Lesion

Procedure

Pace During 2nd Half of Lesion

Procedure

Primary outcomes

  1. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein

    Time frame: 20 Seconds

  2. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left middle pulmonary vein

    Time frame: 20 Seconds

  3. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein

    Time frame: 20 Seconds

  4. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary

    Time frame: 20 Seconds

  5. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right middle pulmonary vein

    Time frame: 20 Seconds

  6. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein

    Time frame: 20 Seconds

  7. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein

    Time frame: 30 Seconds

  8. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left pulmonary vein carina

    Time frame: 30 Seconds

  9. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein

    Time frame: 30 Seconds

  10. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary

    Time frame: 30 Seconds

  11. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right pulmonary vein carina

    Time frame: 30 Seconds

  12. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein

    Time frame: 30 Seconds

  13. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Anterior CTI

    Time frame: 30 Seconds

  14. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Middle CTI

    Time frame: 30 Seconds

  15. Percentage of time spent above CF 10 grams between paced and non-paced lesions at Posterior CTI

    Time frame: 30 Seconds

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Acronym: PEP AF

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 10, 2016
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.