CLOSE to CURE Study

Atrial Fibrillation Clinical Trial

Official title:

'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925624
• Other study ID #: 1949
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2021
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein isolation

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Hospital	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical characteristic assessed by height		At baseline
Other	Clinical characteristic assessed by weight		At baseline
Other	Clinical characteristic assessed by age		At baseline
Other	Clinical characteristic assessed by sex		At baseline
Other	Clinical characteristic assessed by congestive heart failure history		At baseline
Other	Clinical characteristic assessed by hypertension history		At baseline
Other	Clinical characteristic assessed by stroke/TIA/Thromboembolism history		At baseline
Other	Clinical characteristic assessed by vascular disease history		At baseline
Other	Clinical characteristic assessed by diabetes mellitus		At baseline
Other	Clinical characteristic assessed by left ventricle ejection fraction (LVEF)		At baseline
Other	Clinical characteristic assessed by structural heart disease		At baseline
Other	Clinical characteristic assessed by endurance measured by amount of training/cycling per week		At baseline
Other	Clinical characteristic assessed by history of implanted devices		At baseline
Other	Clinical characteristic assessed by LA diameter measured by echocardiography		At baseline
Other	Clinical characteristic assessed by LA volume measured by echocardiography		At baseline
Other	Clinical characteristic assessed by cardiovascular medication history		At baseline
Other	Procedure characteristic assessed by procedure time		At baseline
Other	Procedure characteristic assessed by radiofrequency time		At baseline
Other	Procedure characteristic assessed by fluoroscopy time		At baseline
Other	Electrophysiological characteristic assessed by voltage mapping of the LA	Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the LA	At baseline
Other	Electrophysiological characteristic assessed by atrial refractoriness	This will be done by premature stimulation protocol	At baseline
Other	Electrophysiological characteristic assessed by conduction velocity	This will be done by premature stimulation protocol	At baseline
Other	Electrophysiological characteristic assessed by AF inducibility	This will be done by premature stimulation protocol	At baseline
Primary	Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI		Continuous monitoring (24 hours loop recording)
Primary	Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure		Continuous monitoring (24 hours loop recording)
Secondary	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	3 months to 3 years
Secondary	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)	3 months to 3 years
Secondary	Incidence of adverse events related to ablation		Baseline to 3 years
Secondary	Freedom from stroke/transient ischemic attack (TIA)		Baseline to 3 years
Secondary	Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)	ATA include fibrillation, tachycardia, or flutter	1 month to 3 years
Secondary	Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures		1 month to 3 years
Secondary	Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA	ATA include fibrillation, tachycardia, or flutter	1 month to 3 years
Secondary	Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey		Recruitment to 3 years
Secondary	Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3		Recruitment to 3 years
Secondary	Health economics and outcomes research assessed by number of hospitalization	Includes total number of hospitalizations and unscheduled arrhythmia-related health care provider visits	Recruitment to 3 years