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Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04342312
Acronym
ISOLATION
Enrollment
500
Registered
2020-04-13
Start date
2020-03-05
Completion date
2024-05-01
Last updated
2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent

Keywords

Pulmonary Vein Isolation, Cryoballoon ablation, Radiofrequency ablation, Atrial fibrillation

Brief summary

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.

Interventions

PROCEDUREPulmonary vein isolation

Participation in this study does not influence the choice of ablation technique. Usually, cryoballoon ablation is chosen for patients with paroxysmal AF and no previous ablations. Radiofrequency ablation is often used for redo procedures or for patients with persistent AF. Hybrid ablations are most applied in persistent AF patients. However, physicians may deviate from these standard approaches for a variety of reasons, including personal experience or preference.

Sponsors

Maastricht University Medical Center
CollaboratorOTHER
Radboud University Medical Center
CollaboratorOTHER
Maastricht University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Ablation success12 monthsAblation 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.

Secondary

MeasureTime frame
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
Disease progression to persistent or permanent AF.24 months
Time to recurrence of AF or atrial arrhythmia after the blanking period24 months
Use of antiarrhythmic drugs (AADs) one year after ablation.12 months
Number of veins with pulmonary vein reconnection at redo procedure.24 months
Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.12 months

Countries

Netherlands

Contacts

Primary ContactDominique VM Verhaert, MD
dominique.verhaert@radboudumc.nl+31 24 30 92470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026