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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Oxford University Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr Michael Jones, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01629056
First received: June 25, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Atrial Fibrillation
Procedure: ablation
Procedure: RF ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of acute venous electrical reconnections [ Time Frame: acute (intra-procedure) ] [ Designated as safety issue: No ]
    proportion of pulmonary veins found to be electrically reconnected to the left atrium at the end of the index procedure

  • touch-up ablation requirements [ Time Frame: acute (intra-procedure) ] [ Designated as safety issue: No ]
    proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure

  • procedure time [ Time Frame: acute ] [ Designated as safety issue: No ]
    duration of procedure

  • RF time [ Time Frame: acute (intra-procedure) ] [ Designated as safety issue: No ]
    total amount of radiofrequency ablation required

  • anatomical location of reconnections at repeat procedure [ Time Frame: at repeat ablation procerdure (6-12 months post index ablation procedure) ] [ Designated as safety issue: No ]
    anatomical location of electrical reconnections in pulmonary vein antra, as measured at a repeat ablation procedure

  • 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) ] [ Designated as safety issue: No ]
    total time of RF delivery required to re-isolate the reconnected pulmonary veins at a repeat ablation procedure

  • complications [ Time Frame: acute and subacute (intra-procedure, and during entire follow-up period) ] [ Designated as safety issue: Yes ]
    procedure-related complications


Estimated Enrollment: 156
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
  • RF ablation
  • Percutaneous transvenous catheter ablation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629056

Contacts
Contact: Michael A Jones, MBBS +441865740406 ext 740406 michael.jones@orh.nhs.uk
Contact: Timothy R Betts, MBCHB PhD +441865220256 ext 220256 tim.betts@orh.nhs.uk

Locations
United Kingdom
John Radcliffe Hospital Recruiting
Headington, Oxfordshire, United Kingdom, Ox39DU
Contact: michael a jones, MBBS    +441586740406 ext 740406    michael.jones@orh.nhs.uk   
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
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

No publications provided

Responsible Party: Dr Michael Jones, Electrophysiology research fellow, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01629056     History of Changes
Other Study ID Numbers: 77431/244334/1/228, 11/SC/0398
Study First Received: June 25, 2012
Last Updated: June 26, 2012
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Oxford University Hospitals NHS Trust:
atrial fibrillation
ablation
contact

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

ClinicalTrials.gov processed this record on October 21, 2014