Clinical trial NCT04342312: Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
Official title: Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Atrial Fibrillation Paroxysmal
Atrial Fibrillation, Persistent
Keywords: Pulmonary Vein Isolation
Cryoballoon ablation
Radiofrequency ablation
Atrial fibrillation
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Radboud University Medical Center
First posted: 2020-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ablation success
timeFrame: 12 months
Secondary outcomes:
measure: Time to recurrence of AF or atrial arrhythmia after the blanking period
timeFrame: 24 months
measure: Early recurrences of AF or atrial arrhythmia, defined as any episode of AF AT or non-isthmus dependent AFl during the blanking period.
timeFrame: 3 months
measure: Disease progression to persistent or permanent AF.
timeFrame: 24 months
measure: Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.
timeFrame: 12 months
measure: Use of antiarrhythmic drugs (AADs) one year after ablation.
timeFrame: 12 months
measure: Number of veins with pulmonary vein reconnection at redo procedure.
timeFrame: 24 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
Study officials:
affiliation: Maastricht University, departments of physiology and cardiology
name: Ulrich Schotten, MD PhD
role: STUDY_CHAIR
affiliation: Maastricht UMC+ and Radboudumc, department of cardiology
name: Kevin Vernooy, MD PhD
role: STUDY_CHAIR
References: