Clinical trial NCT02925624: CLOSE to CURE Study
Official title: 'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: ablation index
pulmonary vein isolation
implantable loop recorder
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI
timeFrame: Continuous monitoring (24 hours loop recording)
measure: Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure
timeFrame: Continuous monitoring (24 hours loop recording)
Secondary outcomes:
measure: Evaluating PV re-connection at redo procedure assessed by Lasso catheter
timeFrame: 3 months to 3 years
measure: Evaluating progression of scarring at redo procedure assessed by voltage mapping
timeFrame: 3 months to 3 years
measure: Incidence of adverse events related to ablation
timeFrame: Baseline to 3 years
measure: Freedom from stroke/transient ischemic attack (TIA)
timeFrame: Baseline to 3 years
measure: Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)
timeFrame: 1 month to 3 years
measure: Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures
timeFrame: 1 month to 3 years
measure: Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA
timeFrame: 1 month to 3 years
measure: Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey
timeFrame: Recruitment to 3 years
measure: Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3
timeFrame: Recruitment to 3 years
measure: Health economics and outcomes research assessed by number of hospitalization
timeFrame: Recruitment to 3 years
Other outcomes:
measure: Clinical characteristic assessed by height
timeFrame: At baseline
measure: Clinical characteristic assessed by weight
timeFrame: At baseline
measure: Clinical characteristic assessed by age
timeFrame: At baseline
measure: Clinical characteristic assessed by sex
timeFrame: At baseline
measure: Clinical characteristic assessed by congestive heart failure history
timeFrame: At baseline
measure: Clinical characteristic assessed by hypertension history
timeFrame: At baseline
measure: Clinical characteristic assessed by stroke/TIA/Thromboembolism history
timeFrame: At baseline
measure: Clinical characteristic assessed by vascular disease history
timeFrame: At baseline
measure: Clinical characteristic assessed by diabetes mellitus
timeFrame: At baseline
measure: Clinical characteristic assessed by left ventricle ejection fraction (LVEF)
timeFrame: At baseline
measure: Clinical characteristic assessed by structural heart disease
timeFrame: At baseline
measure: Clinical characteristic assessed by endurance measured by amount of training/cycling per week
timeFrame: At baseline
measure: Clinical characteristic assessed by history of implanted devices
timeFrame: At baseline
measure: Clinical characteristic assessed by LA diameter measured by echocardiography
timeFrame: At baseline
measure: Clinical characteristic assessed by LA volume measured by echocardiography
timeFrame: At baseline
measure: Clinical characteristic assessed by cardiovascular medication history
timeFrame: At baseline
measure: Procedure characteristic assessed by procedure time
timeFrame: At baseline
measure: Procedure characteristic assessed by radiofrequency time
timeFrame: At baseline
measure: Procedure characteristic assessed by fluoroscopy time
timeFrame: At baseline
measure: Electrophysiological characteristic assessed by voltage mapping of the LA
timeFrame: At baseline
measure: Electrophysiological characteristic assessed by atrial refractoriness
timeFrame: At baseline
measure: Electrophysiological characteristic assessed by conduction velocity
timeFrame: At baseline
measure: Electrophysiological characteristic assessed by AF inducibility
timeFrame: At baseline
Locations:
city: Bruges
country: Belgium
facility: AZ Sint-Jan Hospital
Study officials:
affiliation: Department of Cardiology, AZ Sint-Jan Hospital Bruges, Belgium
name: Mattias Duytschaever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T, Debonnaire P, Wolf M, Vandekerckhove Y, Knecht S, Tavernier R. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart Rhythm. 2020 Apr;17(4):535-543. doi: 10.1016/j.hrthm.2019.11.004. Epub 2019 Nov 9.