Title: CLOSE-guided pulmonary vein isolation (PVI) as Cure for Paroxysmal Atrial Fibrillation ('CLOSE to CURE' study) Design: This is a prospective, observational, single-center, unblinded, clinical 3-year study. Background: In a population of paroxysmal atrial fibrillation (AF) 'CLOSE'-guided PVI, a new approach to obtain single-procedure durable PVI, has been shown to virtually eliminate recurrence of AF at 1 year follow-up with repetitive but discontinuous Holter monitoring. Objectives: (1) To objectively compare atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI using continuous monitoring. (2) To assess ATA burden using continuous monitoring up to 3 years after ablation. (3) To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome. Enrollment: Up to 100 subjects will be enrolled in this observational, prospective study. Clinical Sites: 1 site. Subject Population: Eligible patients are patients with paroxysmal high-burden AF who are planned for a 'CLOSE'-guided PV isolation. At the time of procedural planning we will ask the patient his/her consent for (1) implantation of a subcutaneous continuous loop recorder (sCLR), (2) a concise electrophysiological study at the time of PVI, (3) a transthoracic echocardiogram at the time of PVI and (4) collection of data during 3 years. Anti-arrhythmic drug treatment (ADT) and oral anticoagulation (OAC) will be given according the updated 2012 European society of Cardiology (ESC) guidelines on AF (Camm et al, European Heart Journal 2012) and the 2012 Heart rhythm society (HRS)/European Heart Rhythm association/European cardiac arrhythmic society Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation (Calkins et al, Heart Rhythm 2012).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
AZ Sint-Jan Hospital
Bruges, Belgium
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI
Time frame: Continuous monitoring (24 hours loop recording)
Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure
Time frame: Continuous monitoring (24 hours loop recording)
Evaluating PV re-connection at redo procedure assessed by Lasso catheter
Visual inspection of electrograms on the Lasso catheter will be performed to verify durable PV isolation or re-connection
Time frame: 3 months to 3 years
Evaluating progression of scarring at redo procedure assessed by voltage mapping
Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the left atrium (LA)
Time frame: 3 months to 3 years
Incidence of adverse events related to ablation
Time frame: Baseline to 3 years
Freedom from stroke/transient ischemic attack (TIA)
Time frame: Baseline to 3 years
Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)
ATA include fibrillation, tachycardia, or flutter
Time frame: 1 month to 3 years
Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures
Time frame: 1 month to 3 years
Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA
ATA include fibrillation, tachycardia, or flutter
Time frame: 1 month to 3 years
Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey
Time frame: Recruitment to 3 years
Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3
Time frame: Recruitment to 3 years
Health economics and outcomes research assessed by number of hospitalization
Includes total number of hospitalizations and unscheduled arrhythmia-related health care provider visits
Time frame: Recruitment to 3 years
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