ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Ablation success [12 months]
Freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.
Secondary Outcome Measures
- Time to recurrence of AF or other atrial arrhythmia after the blanking period. [3 to 24 months]
Time to recurrence of AF or other atrial arrhythmia after the blanking period of 3 months.
- Early recurrences of AF or other atrial arrhythmia [0 to 3 months]
Defined as any episode of documented arrhythmia during the blanking period, defined as within 3 months
- Number of participants with disease progression to persistent or permanent AF. [0 to 24 months]
Disease progression to persistent or permanent AF. Persistent AF is defined as AF that lasts longer than 7 days. Permanent AF can't be corrected with treatments.
- Use of antiarrhythmic drugs (AADs) one year after ablation. [0 to 24 months]
Use of antiarrhythmic drugs (AADs) one year after ablation
- Interleukin 6 (IL-6) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Pro-brain natriuretic peptide 2 (pro-BNP2) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Fibroblast growth factor 23 (FGF-23) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Dickkopf-related protein 3 (DKK-3) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Angiopoietin 2 (ANG-2) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Endothelial cell-specific molecule 1 (ESM-1) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Insulin-like growth factor-binding protein 7 (IGFBP-7) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Bone morphogenetic protein 10 (BMP-10) level [0 to 24 months]
Change in circulating biomarker for substrate quantification.
- Redo procedures [0 to 24 months]
Defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal.
- Number of veins with pulmonary vein reconnection at redo procedure. [0 to 24 months]
Number of veins with pulmonary vein reconnection at redo procedure.
- Major adverse cardiovascular events (MACE). [0 to 24 months]
Major adverse cardiovascular events (MACE).
- Procedure time [Intraoperative]
Defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths).
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older;
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Documented atrial fibrillation;
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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;
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Able and willing to provide written informed consent.
Exclusion Criteria:
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Conditions preventing the patient from adhering from the study protocol;
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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:
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Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
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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):
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Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
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Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Maastricht University Medical Center
- Maastricht University
Investigators
- Principal Investigator: Kevin Vernooy, MD. PhD, Maastricht UMC+ & Radboudumc
- Principal Investigator: Dominik Linz, MD, PhD, Maastricht UMC+ & Radboudumc & University of Adelaide and Royal Adelaide Hospital & University of Copenhagen
- Principal Investigator: Ulrich Schotten, MD, PhD, Maastricht University & Cardiovascular Research Institute Maastricht
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL80761.068.22