Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?
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).


Options:
A: Arm Label: Cohort 1; Type: N/A; Interventions: N/A | Arm Label: Cohort 2; Type: N/A; Interventions: N/A | Arm Label: Cohort 3; Type: N/A; Interventions: N/A | Arm Label: Cohort 4; Type: N/A; Interventions: N/A | Arm Label: Cohort 5; Type: N/A; Interventions: N/A
B: Arm Label: CLOSE guided PVI and insertable cardiac monitor; Type: EXPERIMENTAL; Interventions: Procedure: Pulmonary vein isolation | Intervention Type: PROCEDURE; Name: Pulmonary vein isolation; Assigned to Arm(s): CLOSE guided PVI and insertable cardiac monitor
C: Arm Label: Left Atrial Ablation; Type: ACTIVE_COMPARATOR; Interventions: Device: Left atrial ablation | Arm Label: Rate or Rhythm Control Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rate or Rhythm Control Therapy | Intervention Type: DEVICE; Name: Left atrial ablation; Assigned to Arm(s): Left Atrial Ablation | Intervention Type: DRUG; Name: Rate or Rhythm Control Therapy; Assigned to Arm(s): Rate or Rhythm Control Therapy
D: Arm Label: Lifestyle Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention | Arm Label: Diabetes Support and Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Diabetes Support and Education | Intervention Type: BEHAVIORAL; Name: Lifestyle Intervention; Assigned to Arm(s): Lifestyle Intervention | Intervention Type: BEHAVIORAL; Name: Diabetes Support and Education; Assigned to Arm(s): Diabetes Support and Education

Answer: B