Clinical trial NCT01629056: The Contact PVI Study: Use of Tissue Contact Data to Guide Atrial Fibrillation Ablation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
ablation
contact
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of acute venous electrical reconnections
timeFrame: acute (intra-procedure)
measure: touch-up ablation requirements
timeFrame: acute (intra-procedure)
measure: procedure time
timeFrame: acute
measure: RF time
timeFrame: acute (intra-procedure)
measure: anatomical location of reconnections at repeat procedure
timeFrame: at repeat ablation procerdure (6-12 months post index ablation procedure)
measure: amount of RF required to achieve re-isolation at repeat ablation procedure
timeFrame: at repeat ablation procedure (6-12 months post-index ablation procedure)
measure: complications
timeFrame: acute and subacute (intra-procedure, and during entire follow-up period)
Other outcomes:
Locations:
city: Headington
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Michael A Jones, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford University Hospitals NHS Trust
name: Tim R Betts, MbCHb PhD
role: STUDY_DIRECTOR
References: