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Not yet recruiting NCT05381805

ISOLATION 2.0: a Multicenter Clinical Care and Research Platform

— Observational Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform

Overview

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.

Primary outcome measures

  • Ablation success [Time frame: 12 months]
Secondary outcome measures (12)
  • Time to recurrence of AF or other atrial arrhythmia after the blanking period. [Time frame: 3 to 24 months]
  • Early recurrences of AF or other atrial arrhythmia [Time frame: 0 to 3 months]
  • Number of participants with disease progression to persistent or permanent AF. [Time frame: 0 to 24 months]
  • Use of antiarrhythmic drugs (AADs) one year after ablation. [Time frame: 0 to 24 months]
  • Interleukin 6 (IL-6) level [Time frame: 0 to 24 months]
  • Pro-brain natriuretic peptide 2 (pro-BNP2) level [Time frame: 0 to 24 months]
  • Fibroblast growth factor 23 (FGF-23) level [Time frame: 0 to 24 months]
  • Dickkopf-related protein 3 (DKK-3) level [Time frame: 0 to 24 months]
  • Angiopoietin 2 (ANG-2) level [Time frame: 0 to 24 months]
  • Endothelial cell-specific molecule 1 (ESM-1) level [Time frame: 0 to 24 months]
  • Insulin-like growth factor-binding protein 7 (IGFBP-7) level [Time frame: 0 to 24 months]
  • Bone morphogenetic protein 10 (BMP-10) level [Time frame: 0 to 24 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05381805 · NL80761.068.22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗