- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04342312
Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation (ISOLATION)
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
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dominique VM Verhaert, MD
- Phone Number: +31 24 30 92470
- Email: dominique.verhaert@radboudumc.nl
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL70787.068.19
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.
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