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

NHS Trust

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Procedure: RF ablation; Procedure: ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01629056

77431/244334/1/228

11/SC/0398 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups, including a placebo group

Contact ECI active

Active Comparator group

Description:

Contact ECI active

Treatment:

Procedure: ablation

Contact information deactivated

Placebo Comparator group

Description:

RF ablation without contact data

Treatment:

Procedure: RF ablation