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

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ClinicalTrials.gov Identifier: NCT01629056
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: ablation Procedure: RF ablation Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2012
Primary Completion Date : December 2013
Study Completion Date : February 3, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Contact ECI active
Contact ECI active
Procedure: ablation
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
Placebo Comparator: Contact information deactivated
RF ablation without contact data
Procedure: RF ablation
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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629056

United Kingdom
John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom, Ox39DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Principal Investigator: Michael A Jones, MBBS Oxford University Hospitals NHS Trust
Study Director: Tim R Betts, MbCHb PhD Oxford University Hospitals NHS Trust
More Information

Responsible Party: Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01629056     History of Changes
Other Study ID Numbers: 77431/244334/1/228
11/SC/0398 ( Other Identifier: Oxford C NRES Committee South Central )
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Oxford University Hospitals NHS Trust:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes