The Contact PVI Study: Use of Tissue Contact Data to Guid... | NCT01629056

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

NCT01629056

Sponsor

Oxford University Hospitals NHS Trust

Status

Completed

Last Update Posted

Oct 13, 2017Actual

Enrollment

148Actual

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

ablation
RF ablation

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
11/SC/0398	Other Identifier	Oxford C NRES Committee South Central

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Feb 3, 2014Actual

First Submitted Date

Jun 25, 2012

First Submission Date that Met QC Criteria

Jun 26, 2012

First Posted Date

Jun 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Contact ECI active	Active Comparator	Contact ECI active	Procedure: ablation
Contact information deactivated	Placebo Comparator	RF ablation without contact data	Procedure: RF ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ablation	Procedure	RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)	Contact ECI active

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is undergoing de novo pulmonary vein isolation procedure.
Participant is willing and able to give informed consent for participation in the study.
Male or Female, ≥18 years of age.

Exclusion Criteria:

Previous percutaneous or open surgical procedure involving the left atrium
Pregnancy (current or currently planning)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael A Jones, MBBS	Oxford University Hospitals NHS Trust	Principal Investigator
Tim R Betts, MbCHb PhD	Oxford University Hospitals NHS Trust	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John Radcliffe Hospital		Headington	Oxfordshire	Ox39DU	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

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Browse Branches

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