Clinical trial NCT05381805: ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Official title: Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Ablation
Pulmonary Vein Isolation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2022-05-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from two hospitals in the Netherlands with documented AF, referred for AF ablation.

Brief summary: Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. The aim is to create a clinical characterization platform for patients scheduled for AF ablations with the purpose to optimize health care processes and related translational research.

Detailed description: Study design: Prospective cohort study and research platform of patients referred for AF ablation. Clinical characteristics and results of routine tests and procedures before, during and after AF ablation are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, and questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* Documented atrial fibrillation;
* Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Conditions preventing the patient from adhering from the study protocol;
* Emergency procedures.

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:

* Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
* Severe allergic reaction against body surface electrodes

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:

• Status after esophageal or gastric surgery

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:

• Contraindication to MRI

A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:

• Prior catheter or surgical AF ablation.

Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):

* Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
* Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
* Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.

Primary outcomes:
measure: Ablation success
timeFrame: 12 months
Secondary outcomes:
measure: Time to recurrence of AF or other atrial arrhythmia after the blanking period.
timeFrame: 3 to 24 months
measure: Early recurrences of AF or other atrial arrhythmia
timeFrame: 0 to 3 months
measure: Number of participants with disease progression to persistent or permanent AF.
timeFrame: 0 to 24 months
measure: Use of antiarrhythmic drugs (AADs) one year after ablation.
timeFrame: 0 to 24 months
measure: Interleukin 6 (IL-6) level
timeFrame: 0 to 24 months
measure: Pro-brain natriuretic peptide 2 (pro-BNP2) level
timeFrame: 0 to 24 months
measure: Fibroblast growth factor 23 (FGF-23) level
timeFrame: 0 to 24 months
measure: Dickkopf-related protein 3 (DKK-3) level
timeFrame: 0 to 24 months
measure: Angiopoietin 2 (ANG-2) level
timeFrame: 0 to 24 months
measure: Endothelial cell-specific molecule 1 (ESM-1) level
timeFrame: 0 to 24 months
measure: Insulin-like growth factor-binding protein 7 (IGFBP-7) level
timeFrame: 0 to 24 months
measure: Bone morphogenetic protein 10 (BMP-10) level
timeFrame: 0 to 24 months
measure: Redo procedures
timeFrame: 0 to 24 months
measure: Number of veins with pulmonary vein reconnection at redo procedure.
timeFrame: 0 to 24 months
measure: Major adverse cardiovascular events (MACE).
timeFrame: 0 to 24 months
measure: Procedure time
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht UMC+ & Radboudumc
name: Kevin Vernooy, MD. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht UMC+ & Radboudumc & University of Adelaide and Royal Adelaide Hospital & University of Copenhagen
name: Dominik Linz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University & Cardiovascular Research Institute Maastricht
name: Ulrich Schotten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: