NCT02924181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2018

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

May 19, 2016

Last Update Submit

March 16, 2020

Conditions

Atrial Fibrillation

Keywords

pulmonary vein isolationcontact force sensing catheter

Outcome Measures

Primary Outcomes (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

    Immediate after PV isolation (acute result)

Secondary Outcomes (1)

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

    1 year

Study Arms (4)

Lt PV CF guided/rt PV CF blinded

ACTIVE COMPARATOR

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

Lt PV CF blinded/rt PV CF guided

ACTIVE COMPARATOR

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

Rt PV CF guided/lt PV CF blinded

ACTIVE COMPARATOR

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

Rt PV CF blinded/lt PV CF guided

ACTIVE COMPARATOR

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

Interventions

SmartTouch CatheterDEVICE

Pulmonary vein (PV) isolation guided by CF information

Also known as: Contact force guided pulmonary vein isolation
Lt PV CF blinded/rt PV CF guidedLt PV CF guided/rt PV CF blindedRt PV CF blinded/lt PV CF guidedRt PV CF guided/lt PV CF blinded

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 25068575RESULT

  • 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.

    PMID: 25125294RESULT

  • 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.

    PMID: 24433324RESULT

  • 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.

    PMID: 24177370RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eue-Keun Choi, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2016

First Posted

October 5, 2016

Study Start

June 1, 2015

Primary Completion

October 23, 2017

Study Completion

October 11, 2018

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Locations

KR(1)