Atrial Fibrillation Clinical Trial
— ISOLATIONOfficial title:
Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study
NCT number | NCT04342312 |
Other study ID # | NL70787.068.19 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 5, 2020 |
Est. completion date | May 1, 2024 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | May 1, 2024 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht UMC+ | Maastricht | Limburg |
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Maastricht University | Maastricht University Medical Center, Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ablation success | 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 | Time to recurrence of AF or atrial arrhythmia after the blanking period | 24 months | ||
Secondary | Early recurrences of AF or atrial arrhythmia, defined as any episode of AF AT or non-isthmus dependent AFl during the blanking period. | 3 months | ||
Secondary | Disease progression to persistent or permanent AF. | 24 months | ||
Secondary | Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification. | 12 months | ||
Secondary | Use of antiarrhythmic drugs (AADs) one year after ablation. | 12 months | ||
Secondary | Number of veins with pulmonary vein reconnection at redo procedure. | 24 months |
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