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Comparison Between Contact Force Guided and Blinded Strategy on PV Isolation in AF Patients

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ClinicalTrials.gov Identifier: NCT02924181
Recruitment Status : Unknown
Verified October 2016 by Eue-Keun Choi, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
Keimyung University Dongsan Medical Center
Information provided by (Responsible Party):
Eue-Keun Choi, Seoul National University Hospital

Brief Summary:

Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing catheter is a new catheter which has valuable tools to monitor and increase the efficacy of PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on immediate PV isolation and outcome. However, there might be confounding factor as inter-individual variation. Therefore, we would like to compare the efficacy of contact force-sensing catheter within same patient but different veins.

In this study, we would like to confirm the efficacy of contact force-sensing catheter on immediate PV isolation outcome within same patient. This study randomized the right or left PVs whether to use the contact force-sensing function or not. The study design will minimize the inter-individual variation on evaluating the efficacy of contact force-sensing catheter on immediate PV isolation.

Also, in patients who had recurred AF or AT, we would like to evaluate the long-term efficacy of contact force-sensing catheter on PV isolation.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: SmartTouch Catheter Phase 4

Detailed Description:

Sixty patients will be randomized to select right or left pulmonary veins whether to apply contact force-guided ablation or contact force-blinded ablation strategy. Each PV will be ablated with same contact force-sensing catheter (Thermocool Smart Touch Catheter, Biosense Webster Inc. CA). The PV (right or left) which will be randomized to contact force-sensing PV or blind PV. Contact force-sensing PV will be ablated guided by contact force, whereas the blind PVs will be ablated without contact force-sensing information. The change of impedance, total ablation and time to ablate PV will be collected and analysed according to contact force-sensing strategy. After exit and entrance block by conventional method, dormant conduction will be evaluated by using adenosine. The proportion of dormant conduction will be compared between contact force-sensing guided or blinded strategy.

During 1-year follow up, patients who recurred AF or AT will be undergo second ablation procedure. In these patients, PV reconnection rate will be evaluated by a duodecapolar lasso circular mapping catheter. We would like to know whether PVs which have ablated with contact force-sensing information at index procedure have less reconnection than those which was ablated without contact force-sensing information.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Acute Pulmonary Vein (PV) Reconnection Between Contact Force Guided and Blinded PV Isolation in Patients With Symptomatic Atrial Fibrillation
Study Start Date : June 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lt PV CF guided/rt PV CF blinded
Fifteen patients will be allocated to this group. Left side pulmonary veins isolation will be performed with contact force information guidance. Then, right side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).
Device: SmartTouch Catheter
Pulmonary vein (PV) isolation guided by CF information
Other Name: Contact force guided pulmonary vein isolation

Active Comparator: Lt PV CF blinded/rt PV CF guided
Fifteen patients will be allocated to this group. Left side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).Then, right side pulmonary veins isolation will be performed with contact force information guidance.
Device: SmartTouch Catheter
Pulmonary vein (PV) isolation guided by CF information
Other Name: Contact force guided pulmonary vein isolation

Active Comparator: Rt PV CF guided/lt PV CF blinded
Fifteen patients will be allocated to this group. Right side pulmonary veins isolation will be performed with contact force information guidance. Then, left side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).
Device: SmartTouch Catheter
Pulmonary vein (PV) isolation guided by CF information
Other Name: Contact force guided pulmonary vein isolation

Active Comparator: Rt PV CF blinded/lt PV CF guided
Fifteen patients will be allocated to this group. Right side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter). Then, left side pulmonary veins isolation will be performed with contact force information guidance.
Device: SmartTouch Catheter
Pulmonary vein (PV) isolation guided by CF information
Other Name: Contact force guided pulmonary vein isolation




Primary Outcome Measures :
  1. Proportion of immediate PV isolation ratio after final ablation according to contact force-guided ablation, change of impedance, total ablation time, and procedure time according to contact force-guided strategy [ Time Frame: Immediate after PV isolation (acute result) ]

Secondary Outcome Measures :
  1. Proportion of PV reconnection according to contact force-guided ablation in patients with AF recurrence [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with symptomatic paroxysmal atrial fibrillation (AF) who had failed with anti-arrhythmic agents.

Exclusion Criteria:

  • Patients who had previous ablation for AF
  • Patients with symptomatic persistent AF

Information from the National Library of Medicine

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): NCT02924181


Contacts
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Contact: Eue-Keun Choi 82-2-2072-0688 choiek417@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Jiyeon Kim       jiyeon92515@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: Eue-Keun Choi, MD, PhD Seoul National University Hospital

Publications of Results:

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Responsible Party: Eue-Keun Choi, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02924181     History of Changes
Other Study ID Numbers: SNUH
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Eue-Keun Choi, Seoul National University Hospital:
pulmonary vein isolation
contact force sensing catheter
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes