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

March 16, 2020 updated by: Eue-Keun Choi, Seoul National University Hospital

Comparison of Acute Pulmonary Vein (PV) Reconnection Between Contact Force Guided and Blinded PV Isolation in Patients With Symptomatic Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Contact force guided pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Immediate after PV isolation (acute result)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of PV reconnection according to contact force-guided ablation in patients with AF recurrence
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Keimyung University Dongsan Medical Center

Investigators

  • Principal Investigator: Eue-Keun Choi, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

October 23, 2017

Study Completion (Actual)

October 11, 2018

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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