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The Contact PVI Study: Use of Tissue Contact Data to Guide Atrial Fibrillation Ablation

NCT ID: NCT01629056

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-02-03

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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atrial fibrillation ablation contact

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Contact ECI active

Contact ECI active

Group Type ACTIVE_COMPARATOR

ablation

Intervention Type PROCEDURE

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

Contact information deactivated

RF ablation without contact data

Group Type PLACEBO_COMPARATOR

RF ablation

Intervention Type PROCEDURE

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

Interventions

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ablation

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

Intervention Type PROCEDURE

RF ablation

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

Intervention Type PROCEDURE

Other Intervention Names

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Irrigated RF ablation RF ablation Percutaneous transvenous catheter ablation Irrigated RF ablation Percutaneous transvenous catheter ablation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Previous percutaneous or open surgical procedure involving the left atrium
2. Pregnancy (current or currently planning)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael A Jones, MBBS

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Tim R Betts, MbCHb PhD

Role: STUDY_DIRECTOR

Oxford University Hospitals NHS Trust

Locations

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John Radcliffe Hospital

Headington, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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11/SC/0398

Identifier Type: OTHER

Identifier Source: secondary_id

77431/244334/1/228

Identifier Type: -

Identifier Source: org_study_id