NCT05714800

Brief Summary

Concomitant ablation is an effective treatment for patients with various types of atrial fibrillation undergoing heart surgery. However, recurrences of tachycardias after concomitant ablation can happen and seem to be mostly related to reentry mechanism resulting in atrial tachycardias. The aim of the study is to perform invasive re-mapping of ablated regions in the atria to assess durability of ablation lesions and prevalence of conduction gaps that can be targets for additional ablation to lower longterm arrhythmia recurrence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

January 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2025

Completed
Last Updated

November 8, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

January 22, 2023

Last Update Submit

November 7, 2023

Conditions

Atrial Fibrillation

Keywords

concomitant ablationheart surgeryremapping

Outcome Measures

Primary Outcomes (2)

  • Prevalence of conduction gaps

    Prevalence of conduction gaps in pulmonary vein isolation lines and linear ablation lines found at the invasive re-mapping procedure

    3 months

  • Prevalence of atrial fibrillation/tachycardia before and after delayed invasive re-mapping

    ECG and holter ECG will be performed before and after the re-mapping procedure to assess possible change in prevalence related to closure of potential conduction gaps at the re-mapping procedure

    12 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective surgery for treatment of heart valve disease, surgical coronary artery revascularization, benign cardiac tumors,... having also any type of atrial fibrillation with an indication to undergo concomitant ablation.

You may qualify if:

  • all patients scheduled for any kind of elective heart surgery having also indication (EHRA and/or HRS guidelines) to undergo concomitant ablation for any type of atrial fibrillation

You may not qualify if:

  • life expectancy of less than one year,
  • severe heart failure with left ventricular ejection fraction below 35%,
  • emergency surgery due to a life threatening condition such as acute aortic dissection, papillary muscle rupture, acute endocarditis, major trauma,...

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (5)

  • Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.

    PMID: 31955707BACKGROUND

  • Kornej J, Borschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340. Epub 2020 Jun 18.

    PMID: 32716709BACKGROUND

  • Badhwar V, Rankin JS, Damiano RJ Jr, Gillinov AM, Bakaeen FG, Edgerton JR, Philpott JM, McCarthy PM, Bolling SF, Roberts HG, Thourani VH, Suri RM, Shemin RJ, Firestone S, Ad N. The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation. Ann Thorac Surg. 2017 Jan;103(1):329-341. doi: 10.1016/j.athoracsur.2016.10.076.

    PMID: 28007240BACKGROUND

  • McClure GR, Belley-Cote EP, Jaffer IH, Dvirnik N, An KR, Fortin G, Spence J, Healey J, Singal RK, Whitlock RP. Surgical ablation of atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials. Europace. 2018 Sep 1;20(9):1442-1450. doi: 10.1093/europace/eux336.

    PMID: 29186407RESULT

  • McCarthy PM, Kruse J, Shalli S, Ilkhanoff L, Goldberger JJ, Kadish AH, Arora R, Lee R. Where does atrial fibrillation surgery fail? Implications for increasing effectiveness of ablation. J Thorac Cardiovasc Surg. 2010 Apr;139(4):860-7. doi: 10.1016/j.jtcvs.2009.12.038.

    PMID: 20304134RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matevž Jan, MD

    University Medical Centre Ljubljana

    STUDY CHAIR

Central Study Contacts

Matevž Jan, MD

CONTACT

0038615228238matevz.jan@kclj.si

Tine Prolič Kalinšek, MD

CONTACT

0038615228238tine.prolic.kalinsek@kclj.si

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Electrophysiology specialist

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 6, 2023

Study Start

December 10, 2023

Primary Completion

June 3, 2024

Study Completion

June 3, 2025

Last Updated

November 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)