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Contact Force Sensing Use in Atrial Fibrillation Ablation

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ClinicalTrials.gov Identifier: NCT01630330
Recruitment Status : Unknown
Verified June 2012 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Ablation Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation
Study Start Date : May 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Contact Force Known
Ablation with contact force data known
 Procedure: Ablation
Atrial Fibrillation Ablation with SmartTouch catheter
Experimental: Contact Force Not Known
Contact Force data unavailable during ablation
 Procedure: Ablation
Atrial Fibrillation Ablation with SmartTouch catheter


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Acute Pulmonary Vein Reconnection [ Time Frame: 1 hour post procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic AF

Exclusion Criteria:

  • Recent CVA
  • Contraindication to warfarin therapy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630330


Contacts
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Contact: Shouvik Haldar, MRCP 0207 351 8121 ext 8742 s.haldar@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton & Harefield Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: Tom Wong, MD, FRCP         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
More Information
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01630330    
Other Study ID Numbers: 2012CI002B
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes