Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation (ISOLATION)

May 1, 2020 updated by: Maastricht University

Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study

Rationale:

Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty.

Objectives:

To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.

Study design:

Prospective registry of patients undergoing AF ablation. Clinical characteristics and results of routine tests are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

Study population:

Patients aged 18 years and older with documented AF, scheduled for AF ablation.

Main study endpoints:

Ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

500

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

Study Locations

    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA Nijmegen
        • Recruiting
        • Radboudumc
        • Contact:
          • Dominique VM Verhaert, MD
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC+
        • Contact:
          • Dominique VM Verhaert, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All eligible patients scheduled for AF ablation of at the MUMC+ and Radboudumc will be asked to participate in this cohort study.

Description

Inclusion Criteria:

  • 18 years of age or older;
  • Documented atrial fibrillation;
  • Scheduled for AF ablation or redo AF ablation;
  • Able and willing to provide written informed consent.

Exclusion criteria

  • Serious patient condition before ablation;
  • Physically or mentally unable to provide written informed consent.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation success
Time Frame: 12 months

Ablation success is defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.

Atrial arrhythmias are AF, atrial tachycardia (AT) and non-isthmus dependent atrial flutter (AFl), lasting more than 30 seconds, documented on ECG or Holter monitoring.

12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence of AF or atrial arrhythmia after the blanking period
Time Frame: 24 months
24 months
Early recurrences of AF or atrial arrhythmia, defined as any episode of AF AT or non-isthmus dependent AFl during the blanking period.
Time Frame: 3 months
3 months
Disease progression to persistent or permanent AF.
Time Frame: 24 months
24 months
Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.
Time Frame: 12 months
12 months
Use of antiarrhythmic drugs (AADs) one year after ablation.
Time Frame: 12 months
12 months
Number of veins with pulmonary vein reconnection at redo procedure.
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Investigators

  • Study Chair: Ulrich Schotten, MD PhD, Maastricht University, departments of physiology and cardiology
  • Study Chair: Kevin Vernooy, MD PhD, Maastricht UMC+ and Radboudumc, department of cardiology

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 (Actual)

March 5, 2020

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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