'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- AZ Sint-Jan AV
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Investigators
Prof. Dr. Mattias Duytschaever
Professor Doctor
AZ Sint-Jan AV
Eligibility Criteria
Inclusion Criteria
- •Patients with symptomatic paroxysmal AF (history of self-terminating AF within 7 days or history of self-terminating AF with 1 or more cardioversions within 48 hours after onset), meeting following criteria at the out-patient clinic:
- •patient has at least 3 AF episodes in the last 3 months prior to the visit
- •AF episodes are symptomatic, and patient is drug-resistant (at least one class IC or III), or drug-intolerant (palpitations, fatigue, dyspnea, cardiomyopathy,...)
- •no advanced structural heart disease
- •patient has a CHA2DS2-VASc score of 0, 1, 2, 3 or 4
- •Signed Patient Informed Consent Form.
- •Age 18 years or older.
- •Able and willing to comply with all follow-up testing and requirements.
Exclusion Criteria
- •Persistent atrial fibrillation (history of AF\>7days or history of cardioversion \> 48h of AF)
- •Previous ablation for AF
- •LA antero-posterior diameter \> 50 mm (parasternal long axis view , PLAX)
- •LVEF \< 35% (ejection fraction)
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Coronary artery bypass grafting (CABG) procedure within the last three months
- •Awaiting cardiac transplantation or other cardiac surgery
- •Documented left atrial thrombus on imaging
- •Diagnosed atrial myxoma
- •Women who are pregnant or breastfeeding
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Evaluating PV re-connection at redo procedure assessed by Lasso catheter(3 months to 3 years)
- Incidence of adverse events related to ablation(Baseline to 3 years)
- Freedom from stroke/transient ischemic attack (TIA)(Baseline to 3 years)
- Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA(1 month to 3 years)
- Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey(Recruitment to 3 years)
- Health economics and outcomes research assessed by number of hospitalization(Recruitment to 3 years)
- Evaluating progression of scarring at redo procedure assessed by voltage mapping(3 months to 3 years)
- Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)(1 month to 3 years)
- Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures(1 month to 3 years)
- Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3(Recruitment to 3 years)