The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation (PEP AF)

November 8, 2019 updated by: NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CA 1st Half of lesion
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.
Procedure: Pace During 1st Half of Lesion
Experimental: CA 2nd Half of Lesion
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.
Procedure: Pace During 2nd Half of Lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein
Time Frame: 20 Seconds
20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left middle pulmonary vein
Time Frame: 20 Seconds
20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein
Time Frame: 20 Seconds
20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary
Time Frame: 20 Seconds
20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right middle pulmonary vein
Time Frame: 20 Seconds
20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein
Time Frame: 20 Seconds
20 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left pulmonary vein carina
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left inferior pulmonary vein
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right superior pulmonary
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right pulmonary vein carina
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Right inferior pulmonary vein
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Anterior CTI
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Middle CTI
Time Frame: 30 Seconds
30 Seconds
Percentage of time spent above CF 10 grams between paced and non-paced lesions at Posterior CTI
Time Frame: 30 Seconds
30 Seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Anthony Aizer, MD, New York University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 2, 2017

Study Completion (Actual)

May 2, 2017

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-00813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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