Status:
NOT_YET_RECRUITING
ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Maastricht University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-99 years
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 ...
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 abla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05381805
Start Date
August 1 2022
End Date
August 1 2028
Last Update
May 19 2022
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