NCT04466358

Brief Summary

The aim of this study is to compare two methods of catheter ablation for treatment of paroxysmal atrial fibrillation (AF). The first method being a modified CLOSE protocol used for the control group and the second high density mapping guided isolation of pulmonary veins used for the interventional group. Comparison will be made according to clinical parameters and also durability of pulmonary vein 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

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

3.5 years

First QC Date

July 7, 2020

Last Update Submit

October 14, 2024

Conditions

Pulmonary Vein Isolation

Keywords

pulmonary vein isolationparoxysmal atrial fibrillationhigh density mapping

Outcome Measures

Primary Outcomes (2)

  • Recurrence of atrial fibrillation

    Atrial fibrillation recorded with 12-lead ECG, event monitor or a 30 seconds episode recorded with Holter ECG.

    3-12 months

  • Durability of pulmonary vein isolation

    Presence of gaps in the circumferential ablation line (reconduction of pulmonary veins) as evidenced at predefined remapping procedure.

    12 months

Secondary Outcomes (1)

  • Characteristics of gaps in ablation lines

    0-12 months

Other Outcomes (1)

  • Adverse events

    0-1 month

Study Arms (2)

Modified CLOSE protocol

EXPERIMENTAL

Width antral circumferential pulmonary vein isolation guided according to CLOSE protocol, confirmed with multipolar circular mapping catheter.

Procedure: Modified CLOSE protocol

High density mapping guided pulmonary vein isolation

ACTIVE COMPARATOR

Width antral circumferential pulmonary vein isolation guided according to CLOSE protocol and confirmed with high density mapping of each pulmonary vein antrum, with additional ablation lesions at sites of gap or dormant conduction.

Procedure: High density mapping guided pulmonary vein isolation

Interventions

Modified CLOSE protocolPROCEDURE

Modified CLOSE protocol guided isolation of pulmonary veins.

Modified CLOSE protocol
High density mapping guided pulmonary vein isolationPROCEDURE

Modified CLOSE protocol guided isolation of pulmonary veins with additional ablations at sites of gaps or dormant conduction as evidenced by high density mapping of pulmonary vein antra.

High density mapping guided pulmonary vein isolation

Eligibility Criteria

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

You may qualify if:

  • electrocardiographic evidence of paroxysmal AF in the last six months,
  • unsuccessful treatment with antiarrhythmic drugs or highly symptomatic arrhythmia episodes (EHRA 3 and 4).

You may not qualify if:

  • age over 80 years,
  • greatly enlarged left atrium (ultrasound parasternal diameter more than 50 mm),
  • life expectancy less than one year,
  • acute life-threatening disease,
  • previous heart surgery,
  • severe left or right ventricular dysfunction (LVEF equal or less than 35 %),
  • severe valve failure,
  • presence of a clot in the left atrium,
  • previous atrial fibrillation ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (6)

  • Phlips T, Taghji P, El Haddad M, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Duytschaever M. Improving procedural and one-year outcome after contact force-guided pulmonary vein isolation: the role of interlesion distance, ablation index, and contact force variability in the 'CLOSE'-protocol. Europace. 2018 Nov 1;20(FI_3):f419-f427. doi: 10.1093/europace/eux376.

    PMID: 29315411BACKGROUND

  • Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol. 2018 Jan;4(1):99-108. doi: 10.1016/j.jacep.2017.06.023. Epub 2017 Sep 27.

    PMID: 29600792BACKGROUND

  • Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T, Debonnaire P, Wolf M, Vandekerckhove Y, Knecht S, Tavernier R. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart Rhythm. 2020 Apr;17(4):535-543. doi: 10.1016/j.hrthm.2019.11.004. Epub 2019 Nov 9.

    PMID: 31707159BACKGROUND

  • Meissner A, Maagh P, Christoph A, Oernek A, Plehn G. Pulmonary vein potential mapping in atrial fibrillation with high density and standard spiral (lasso) catheters: A comparative study. J Arrhythm. 2017 Jun;33(3):192-200. doi: 10.1016/j.joa.2016.10.562. Epub 2016 Nov 25.

    PMID: 28607614BACKGROUND

  • Segerson NM, Lynch B, Mozes J, Marks MM, Noonan DK, Gordon D, Jais P, Daccarett M. High-density mapping and ablation of concealed low-voltage activity within pulmonary vein antra results in improved freedom from atrial fibrillation compared to pulmonary vein isolation alone. Heart Rhythm. 2018 Aug;15(8):1158-1164. doi: 10.1016/j.hrthm.2018.04.035. Epub 2018 May 3.

    PMID: 29729399BACKGROUND

  • Kajdic N, Kalinsek TP, Antolic B, Zizek D, Stublar J, Demsar J, Kuhelj D, Jan M. Impact of High-Density Mapping on Pulmonary Vein Isolation Durability: A Randomized, Single-Center Study. Pacing Clin Electrophysiol. 2025 Jun;48(6):587-597. doi: 10.1111/pace.15196. Epub 2025 May 6.

    PMID: 40326295DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jernej Stublar, MSE

    University Medical Centre Ljubljana

    STUDY DIRECTOR

  • Bor Antolic, MD, PhD

    University Medical Centre Ljubljana

    STUDY CHAIR

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
Principal investigator

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 10, 2020

Study Start

February 26, 2021

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)