Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions (PLAN-AF)

November 7, 2023 updated by: Matevz Jan, University Medical Centre Ljubljana

Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions for Treatment of Atrial Fibrillation

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.

Study Overview

Status

Recruiting

Conditions

Atrial Fibrillation

Detailed Description

Patients after concomitant ablation for treatment of atrial fibrillation will be enrolled. At ablation procedure pulmonary veins will be isolated and additional ablation lines will be performed in the left atrium (posterior wall box lesion, connecting lesion to the mitral annulus, connecting lesion to the left atrial appendage,...) and the right atrium (intercaval connecting lesion, cavotricuspid isthmus lesion,...) and left atrial appendage will be excluded (suture and excision, clipping device,...) at the discretion and expertise of the operator. Radiofrequency and/or cryoablation will be used at the discretion and expertise of the operator.

Invasive mapping with a high density mapping catheter connected to a three-dimensional electro-anatomical mapping system will be performed to assess pulmonary vein isolation and linear lesion durability 3 months after the initial concomitant ablation. Potential gaps will be identified and ablated with a radiofrequency ablation catheter.

Participants will be followed-up clinically and with holter ECG before and after the invasive re-mapping procedure up to the first year after the concomitant ablation procedure.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

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

Study Contact

Name: Matevž Jan, MD
Phone Number: 0038615228238
Email: matevz.jan@kclj.si

Study Contact Backup

Name: Tine Prolič Kalinšek, MD
Phone Number: 0038615228238
Email: tine.prolic.kalinsek@kclj.si

Study Locations

Slovenia
- - Ljubljana, Slovenia, 1000
    - Recruiting
    - University Medical Centre Ljubljana
    - Contact:
      
      Jernej Štublar
      
      Phone Number: 0038615228232
      
      Email: jernej.stublar@kclj.si
    - Sub-Investigator:
      
      Tine Prolič Kalinšek, MD
    - Principal Investigator:
      
      Matevž Jan, MD
    - Contact:
      
      Matevž Jan, MD
      
      Phone Number: 0038615228238
      
      Email: matevz.jan@kclj.si

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

N/A

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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,...

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of conduction gaps Time Frame: 3 months	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 Time Frame: 12 months	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

Collaborators and Investigators

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

Sponsor

University Medical Centre Ljubljana

Investigators

Study Chair: Matevž Jan, MD, University Medical Centre Ljubljana

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 (Estimated)

December 10, 2023

Primary Completion (Estimated)

June 3, 2024

Study Completion (Estimated)

June 3, 2025

Study Registration Dates

First Submitted

January 22, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PLAN-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.