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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SmartTouch Catheter
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring pulmonary vein isolation, contact force sensing catheter

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lt PV CF guided/rt PV CF blinded

Lt PV CF blinded/rt PV CF guided

Rt PV CF guided/lt PV CF blinded

Rt PV CF blinded/lt PV CF guided

Arm Description

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).

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.

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of PV reconnection according to contact force-guided ablation in patients with AF recurrence

Full Information

First Posted
May 19, 2016
Last Updated
March 16, 2020
Sponsor
Seoul National University Hospital
Collaborators
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02924181
Brief Title
Comparison Between Contact Force Guided and Blinded Strategy on PV Isolation in AF Patients
Official Title
Comparison of Acute Pulmonary Vein (PV) Reconnection Between Contact Force Guided and Blinded PV Isolation in Patients With Symptomatic Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Keimyung University Dongsan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
pulmonary vein isolation, contact force sensing catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lt PV CF guided/rt PV CF blinded
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Lt PV CF blinded/rt PV CF guided
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rt PV CF guided/lt PV CF blinded
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Rt PV CF blinded/lt PV CF guided
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SmartTouch Catheter
Other Intervention Name(s)
Contact force guided pulmonary vein isolation
Intervention Description
Pulmonary vein (PV) isolation guided by CF information
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of PV reconnection according to contact force-guided ablation in patients with AF recurrence
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eue-Keun Choi, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25068575
Citation
Andrade JG, Monir G, Pollak SJ, Khairy P, Dubuc M, Roy D, Talajic M, Deyell M, Rivard L, Thibault B, Guerra PG, Nattel S, Macle L. Pulmonary vein isolation using "contact force" ablation: the effect on dormant conduction and long-term freedom from recurrent atrial fibrillation--a prospective study. Heart Rhythm. 2014 Nov;11(11):1919-24. doi: 10.1016/j.hrthm.2014.07.033. Epub 2014 Jul 25.
Results Reference
result
PubMed Identifier
25125294
Citation
Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
Results Reference
result
PubMed Identifier
24433324
Citation
Marijon E, Fazaa S, Narayanan K, Guy-Moyat B, Bouzeman A, Providencia R, Treguer F, Combes N, Bortone A, Boveda S, Combes S, Albenque JP. Real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results. J Cardiovasc Electrophysiol. 2014 Feb;25(2):130-7. doi: 10.1111/jce.12303. Epub 2013 Nov 6.
Results Reference
result
PubMed Identifier
24177370
Citation
Reichlin T, Knecht S, Lane C, Kuhne M, Nof E, Chopra N, Tadros TM, Reddy VY, Schaer B, John RM, Osswald S, Stevenson WG, Sticherling C, Michaud GF. Initial impedance decrease as an indicator of good catheter contact: insights from radiofrequency ablation with force sensing catheters. Heart Rhythm. 2014 Feb;11(2):194-201. doi: 10.1016/j.hrthm.2013.10.048. Epub 2013 Oct 28.
Results Reference
result

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

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