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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629056
• Other study ID #: 77431/244334/1/228
• Secondary ID: 11/SC/0398
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2012
• Last updated: October 11, 2017
• Start date: January 2012
• Est. completion date: February 3, 2014

Study information

• Verified date: October 2017
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 3, 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• ablation
RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)
• RF ablation
RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Headington	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	touch-up ablation requirements	proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure	acute (intra-procedure)
Secondary	procedure time	duration of procedure	acute
Secondary	RF time	total amount of radiofrequency ablation required	acute (intra-procedure)
Secondary	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)
Secondary	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)
Secondary	complications	procedure-related complications	acute and subacute (intra-procedure, and during entire follow-up period)