NCT02766712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2017

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

May 6, 2016

Last Update Submit

November 8, 2019

Conditions

Atrial Fibrillation

Keywords

catheter ablationatrial fibrillation

Outcome Measures

Primary Outcomes (15)

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

    20 Seconds

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

    20 Seconds

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

    20 Seconds

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

    20 Seconds

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

    20 Seconds

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

    20 Seconds

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

    30 Seconds

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

    30 Seconds

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

    30 Seconds

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

    30 Seconds

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

    30 Seconds

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

    30 Seconds

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

    30 Seconds

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

    30 Seconds

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

    30 Seconds

Study Arms (2)

CA 1st Half of lesion

EXPERIMENTAL

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

CA 2nd Half of Lesion

EXPERIMENTAL

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

Interventions

Pace During 1st Half of LesionPROCEDURE
CA 1st Half of lesion
Pace During 2nd Half of LesionPROCEDURE
CA 2nd Half of Lesion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 30067488DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Aizer, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

April 1, 2016

Primary Completion

May 2, 2017

Study Completion

May 2, 2017

Last Updated

November 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)