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

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ClinicalTrials.gov Identifier: NCT02766712
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Pace During 1st Half of Lesion Procedure: Pace During 2nd Half of Lesion Not Applicable

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 If Wenckebach behavior still persists, the patient will be withdrawn from the study.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  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation
Study Start Date : April 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766712


Contacts
Contact: Laura Mendelson kuznel01@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Laura Mendelson       kuznel01@nyumc.org   
Principal Investigator: Anthony Aizer, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Anthony Aizer, MD New York University Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02766712     History of Changes
Other Study ID Numbers: 16-00813
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by New York University School of Medicine:
catheter ablation
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes