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Atrial FibrillationPEP AFNCT02766712

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

A study testing Pace During 1st Half of Lesion and Pace During 2nd Half of Lesion in people with Atrial Fibrillation, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Pace During 1st Half of Lesion and Pace During 2nd Half of Lesion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
Apr 2016to 2 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with AF scheduled for AF ablation with planned pulmonary vein isolation
  • Presenting in normal sinus rhythm (NSR) prior to lesion delivery

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

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.

Read the 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.
Being tested
Pace During 1st Half of Lesion, Pace During 2nd Half of Lesion
Keywords
catheter ablation, atrial fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pace During 1st Half of LesionProcedure or surgery

  • Pace During 2nd Half of LesionProcedure or surgery

Study groups in NCT02766712
Study groupRoleWhat they receive
CA 1st Half of lesionExperimentalDuring 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.
Receives: Procedure: Pace During 1st Half of Lesion
CA 2nd Half of LesionExperimentalDuring 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.
Receives: Procedure: Pace During 2nd Half of Lesion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 20 Seconds

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

    Measured: 20 Seconds

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

    Measured: 20 Seconds

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

    Measured: 20 Seconds

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

    Measured: 20 Seconds

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

    Measured: 20 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

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

    Measured: 30 Seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion2 May 2017
  4. Study completion2 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02766712
Sponsor's protocol ID
16-00813
Acronym
PEP AF
Status last verified
Nov 2019
First submitted
6 May 2016
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 30067488

Questions about this trial

What is this clinical trial studying?

A study testing Pace During 1st Half of Lesion and Pace During 2nd Half of Lesion in people with Atrial Fibrillation, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time spent above CF 10 grams between paced and non-paced lesions at Left superior pulmonary vein (time frame: 20 Seconds). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02766712, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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