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Completed

NCT Number: NCT01629056

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

John Radcliffe Hospital

Headington, Oxfordshire, Ox39DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Ablation

Procedure

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

Other names: Irrigated RF ablation, RF ablation, Percutaneous transvenous catheter ablation

RF ablation

Procedure

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

Other names: Irrigated RF ablation, Percutaneous transvenous catheter ablation

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

    Time frame: 6 months

Secondary outcomes

  1. Proportion of acute venous electrical reconnections

    Time frame: acute (intra-procedure)

    proportion of pulmonary veins found to be electrically reconnected to the left atrium at the end of the index procedure

  2. touch-up ablation requirements

    Time frame: acute (intra-procedure)

    proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure

  3. procedure time

    Time frame: acute

    duration of procedure

  4. RF time

    Time frame: acute (intra-procedure)

    total amount of radiofrequency ablation required

  5. anatomical location of reconnections at repeat procedure

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

    anatomical location of electrical reconnections in pulmonary vein antra, as measured at a repeat ablation procedure

  6. amount of RF required to achieve re-isolation at repeat ablation procedure

    Time frame: at repeat ablation procedure (6-12 months post-index ablation procedure)

    total time of RF delivery required to re-isolate the reconnected pulmonary veins at a repeat ablation procedure

  7. complications

    Time frame: acute and subacute (intra-procedure, and during entire follow-up period)

    procedure-related complications

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study title

The Contact-PVI Study - Does Assessment of Tissue Contact During RF Ablation Using the St. Jude Medical™ Ensite™ Contact™ System Increase Rates of Long-term Pulmonary Vein Isolation? A Prospective Randomised Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 27, 2012
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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