NCT01629056

Brief Summary

This study aims to investigate the benefit of a new impedance-based computer software application during routine catheter ablation for atrial fibrillation, to see if this information improves short and long term electrical disconnection of the pulmonary veins. This study will be a single blind prospective randomised control trial in patients undergoing AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary vein ablation with, and parts of their ablation without tissue contact data displayed for the doctor performing the ablation to see. The pulmonary veins will then be studied at the end of the procedure, and at any repeat procedure in the future, to look for a difference in the recovery rate of the ablations performed using contact data, compared to those ablations performed without the use of this contact data. If a reduction in tissue recovery is achieved through the use of this tissue contact data, it may lead in the future to a reduced need for repeat ablation procedures, and better outcomes for patients. The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing left atrial ablation for atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2014

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

June 25, 2012

Last Update Submit

October 11, 2017

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationablationcontact

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be the proportion (%) of pulmonary vein pairs found to be reconnected electrically to the left atrium at a subsequent redo ablation procedure

    6 months

Secondary Outcomes (7)

  • Proportion of acute venous electrical reconnections

    acute (intra-procedure)

  • touch-up ablation requirements

    acute (intra-procedure)

  • procedure time

    acute

  • RF time

    acute (intra-procedure)

  • anatomical location of reconnections at repeat procedure

    at repeat ablation procerdure (6-12 months post index ablation procedure)

  • +2 more secondary outcomes

Study Arms (2)

Contact ECI active

ACTIVE COMPARATOR

Contact ECI active

Procedure: ablation

Contact information deactivated

PLACEBO COMPARATOR

RF ablation without contact data

Procedure: RF ablation

Interventions

ablationPROCEDURE

RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)

Also known as: Irrigated RF ablation, RF ablation, Percutaneous transvenous catheter ablation
Contact ECI active
RF ablationPROCEDURE

RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)

Also known as: Irrigated RF ablation, Percutaneous transvenous catheter ablation
Contact information deactivated

Eligibility Criteria

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

You may qualify if:

  • Participant is undergoing de novo pulmonary vein isolation procedure.
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, ≥18 years of age.

You may not qualify if:

  • Previous percutaneous or open surgical procedure involving the left atrium
  • Pregnancy (current or currently planning)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital

Headington, Oxfordshire, Ox39DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael A Jones, MBBS

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

  • Tim R Betts, MbCHb PhD

    Oxford University Hospitals NHS Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 27, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 3, 2014

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

GB(1)