ISOLATION 2.0: a Multicenter Clinical Care and Research Platform

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05381805
• Other study ID #: NL80761.068.22
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2028

Study information

• Verified date: May 2022
• Source: Maastricht University Medical Center
• Contact: Zarina Habibi, MD
• Phone: +31-43-3881200
• Email: ablatie.onderzoek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Maastricht University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ablation success	Freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.	12 months
Secondary	Time to recurrence of AF or other atrial arrhythmia after the blanking period.	Time to recurrence of AF or other atrial arrhythmia after the blanking period of 3 months.	3 to 24 months
Secondary	Early recurrences of AF or other atrial arrhythmia	Defined as any episode of documented arrhythmia during the blanking period, defined as within 3 months	0 to 3 months
Secondary	Number of participants with disease progression to persistent or permanent AF.	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.	0 to 24 months
Secondary	Use of antiarrhythmic drugs (AADs) one year after ablation.	Use of antiarrhythmic drugs (AADs) one year after ablation	0 to 24 months
Secondary	Interleukin 6 (IL-6) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Pro-brain natriuretic peptide 2 (pro-BNP2) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Fibroblast growth factor 23 (FGF-23) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Dickkopf-related protein 3 (DKK-3) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Angiopoietin 2 (ANG-2) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Endothelial cell-specific molecule 1 (ESM-1) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Insulin-like growth factor-binding protein 7 (IGFBP-7) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Bone morphogenetic protein 10 (BMP-10) level	Change in circulating biomarker for substrate quantification.	0 to 24 months
Secondary	Redo procedures	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.	0 to 24 months
Secondary	Number of veins with pulmonary vein reconnection at redo procedure.	Number of veins with pulmonary vein reconnection at redo procedure.	0 to 24 months
Secondary	Major adverse cardiovascular events (MACE).	Major adverse cardiovascular events (MACE).	0 to 24 months
Secondary	Procedure time	Defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths).	Intraoperative