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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: ablation; Procedure: RF ablation

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Headington, Oxfordshire, United Kingdom, OX39DU
      • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: RF ablation; Irrigated 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of acute venous electrical reconnections	proportion of pulmonary veins found to be electrically reconnected to the left atrium at the end of the index procedure	acute (intra-procedure)
touch-up ablation requirements	proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure	acute (intra-procedure)
procedure time	duration of procedure	acute
RF time	total amount of radiofrequency ablation required	acute (intra-procedure)
anatomical location of reconnections at repeat procedure	anatomical location of electrical reconnections in pulmonary vein antra, as measured at a repeat ablation procedure	at repeat ablation procerdure (6-12 months post index ablation procedure)
amount of RF required to achieve re-isolation at repeat ablation procedure	total time of RF delivery required to re-isolate the reconnected pulmonary veins at a repeat ablation procedure	at repeat ablation procedure (6-12 months post-index ablation procedure)
complications	procedure-related complications	acute and subacute (intra-procedure, and during entire follow-up period)

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 3, 2014

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 27, 2012

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation; contact
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 77431/244334/1/228; 11/SC/0398 (Other Identifier: Oxford C NRES Committee South Central)