Back to resultsCLOSE to CURE Study
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring ablation index, pulmonary vein isolation, implantable loop recorder
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
- Acute illness or active systemic infection or sepsis
- Unstable angina
- Uncontrolled heart failure
- Myocardial infarction within the previous two months
- History of blood clotting or bleeding abnormalities
- Contraindication to anticoagulation therapy (ie, heparin or warfarin)
- Life expectancy less than 12 months
- Enrollment in any other study evaluating another device or drug
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
Sites / Locations
- AZ Sint-Jan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CLOSE guided PVI and insertable cardiac monitor
Arm Description
Outcomes
Primary Outcome Measures
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI
Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure
Secondary Outcome Measures
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
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)
Incidence of adverse events related to ablation
Freedom from stroke/transient ischemic attack (TIA)
Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)
ATA include fibrillation, tachycardia, or flutter
Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures
Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA
ATA include fibrillation, tachycardia, or flutter
Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey
Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3
Health economics and outcomes research assessed by number of hospitalization
Includes total number of hospitalizations and unscheduled arrhythmia-related health care provider visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02925624
Brief Title
CLOSE to CURE Study
Official Title
'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
ablation index, pulmonary vein isolation, implantable loop recorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLOSE guided PVI and insertable cardiac monitor
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation
Primary Outcome Measure Information:
Title
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI
Time Frame
Continuous monitoring (24 hours loop recording)
Title
Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure
Time Frame
Continuous monitoring (24 hours loop recording)
Secondary Outcome Measure Information:
Title
Evaluating PV re-connection at redo procedure assessed by Lasso catheter
Description
Visual inspection of electrograms on the Lasso catheter will be performed to verify durable PV isolation or re-connection
Time Frame
3 months to 3 years
Title
Evaluating progression of scarring at redo procedure assessed by voltage mapping
Description
Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the left atrium (LA)
Time Frame
3 months to 3 years
Title
Incidence of adverse events related to ablation
Time Frame
Baseline to 3 years
Title
Freedom from stroke/transient ischemic attack (TIA)
Time Frame
Baseline to 3 years
Title
Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)
Description
ATA include fibrillation, tachycardia, or flutter
Time Frame
1 month to 3 years
Title
Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures
Time Frame
1 month to 3 years
Title
Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA
Description
ATA include fibrillation, tachycardia, or flutter
Time Frame
1 month to 3 years
Title
Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey
Time Frame
Recruitment to 3 years
Title
Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3
Time Frame
Recruitment to 3 years
Title
Health economics and outcomes research assessed by number of hospitalization
Description
Includes total number of hospitalizations and unscheduled arrhythmia-related health care provider visits
Time Frame
Recruitment to 3 years
Other Pre-specified Outcome Measures:
Title
Clinical characteristic assessed by height
Time Frame
At baseline
Title
Clinical characteristic assessed by weight
Time Frame
At baseline
Title
Clinical characteristic assessed by age
Time Frame
At baseline
Title
Clinical characteristic assessed by sex
Time Frame
At baseline
Title
Clinical characteristic assessed by congestive heart failure history
Time Frame
At baseline
Title
Clinical characteristic assessed by hypertension history
Time Frame
At baseline
Title
Clinical characteristic assessed by stroke/TIA/Thromboembolism history
Time Frame
At baseline
Title
Clinical characteristic assessed by vascular disease history
Time Frame
At baseline
Title
Clinical characteristic assessed by diabetes mellitus
Time Frame
At baseline
Title
Clinical characteristic assessed by left ventricle ejection fraction (LVEF)
Time Frame
At baseline
Title
Clinical characteristic assessed by structural heart disease
Time Frame
At baseline
Title
Clinical characteristic assessed by endurance measured by amount of training/cycling per week
Time Frame
At baseline
Title
Clinical characteristic assessed by history of implanted devices
Time Frame
At baseline
Title
Clinical characteristic assessed by LA diameter measured by echocardiography
Time Frame
At baseline
Title
Clinical characteristic assessed by LA volume measured by echocardiography
Time Frame
At baseline
Title
Clinical characteristic assessed by cardiovascular medication history
Time Frame
At baseline
Title
Procedure characteristic assessed by procedure time
Time Frame
At baseline
Title
Procedure characteristic assessed by radiofrequency time
Time Frame
At baseline
Title
Procedure characteristic assessed by fluoroscopy time
Time Frame
At baseline
Title
Electrophysiological characteristic assessed by voltage mapping of the LA
Description
Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the LA
Time Frame
At baseline
Title
Electrophysiological characteristic assessed by atrial refractoriness
Description
This will be done by premature stimulation protocol
Time Frame
At baseline
Title
Electrophysiological characteristic assessed by conduction velocity
Description
This will be done by premature stimulation protocol
Time Frame
At baseline
Title
Electrophysiological characteristic assessed by AF inducibility
Description
This will be done by premature stimulation protocol
Time Frame
At baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Acute illness or active systemic infection or sepsis
Unstable angina
Uncontrolled heart failure
Myocardial infarction within the previous two months
History of blood clotting or bleeding abnormalities
Contraindication to anticoagulation therapy (ie, heparin or warfarin)
Life expectancy less than 12 months
Enrollment in any other study evaluating another device or drug
Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Duytschaever, MD, PhD
Organizational Affiliation
Department of Cardiology, AZ Sint-Jan Hospital Bruges, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan Hospital
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
31707159
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.
Results Reference
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