CLOSE to CURE Study

AZ Sint-Jan AV

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT02925624

1949

Details and patient eligibility

About

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).

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. Signed Patient Informed Consent Form.

3. Age 18 years or older.

4. Able and willing to comply with all follow-up testing and requirements.

Exclusion criteria

1. Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
2. Previous ablation for AF
3. LA antero-posterior diameter > 50 mm (parasternal long axis view , PLAX)
4. LVEF < 35% (ejection fraction)
5. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
6. Coronary artery bypass grafting (CABG) procedure within the last three months
7. Awaiting cardiac transplantation or other cardiac surgery
8. Documented left atrial thrombus on imaging
9. Diagnosed atrial myxoma
10. Women who are pregnant or breastfeeding
11. Acute illness or active systemic infection or sepsis
12. Unstable angina
13. Uncontrolled heart failure
14. Myocardial infarction within the previous two months
15. History of blood clotting or bleeding abnormalities
16. Contraindication to anticoagulation therapy (ie, heparin or warfarin)
17. Life expectancy less than 12 months
18. Enrollment in any other study evaluating another device or drug
19. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

CLOSE guided PVI and insertable cardiac monitor

Experimental group

Treatment:

Procedure: Pulmonary vein isolation