Contact Force Sensing Use in Atrial Fibrillation Ablation

NCT ID: NCT01630330

Last Updated: 2012-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-12-31

Brief Summary

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There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.

Detailed Description

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This study compares patients who have this procedure where this contact information is known (unblinded) versus those where the contact information is not known (blinded). The outcome is the rate of acute reconnection at 1 hour after achieving pulmonary vein isolation.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Contact Force Known

Ablation with contact force data known

Group Type ACTIVE_COMPARATOR

Ablation

Intervention Type PROCEDURE

Atrial Fibrillation Ablation with SmartTouch catheter

Contact Force Not Known

Contact Force data unavailable during ablation

Group Type EXPERIMENTAL

Ablation

Intervention Type PROCEDURE

Atrial Fibrillation Ablation with SmartTouch catheter

Interventions

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Ablation

Atrial Fibrillation Ablation with SmartTouch catheter

Intervention Type PROCEDURE

Ablation

Atrial Fibrillation Ablation with SmartTouch catheter

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic AF

Exclusion Criteria

* Recent CVA
* Contraindication to warfarin therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Brompton & Harefield Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Shouvik Haldar, MRCP

Role: CONTACT

0207 351 8121 ext. 8742

Other Identifiers

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2012CI002B

Identifier Type: -

Identifier Source: org_study_id

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