Atrial Fibrillation
Conditions
Keywords
ablation index, pulmonary vein isolation, implantable loop recorder
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).
Interventions
PROCEDUREPulmonary vein isolation
Sponsors
AZ Sint-Jan AV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI | Continuous monitoring (24 hours loop recording) |
| Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure | Continuous monitoring (24 hours loop recording) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating progression of scarring at redo procedure assessed by voltage mapping | 3 months to 3 years | 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 | Baseline to 3 years | — |
| Freedom from stroke/transient ischemic attack (TIA) | Baseline to 3 years | — |
| Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA) | 1 month to 3 years | ATA include fibrillation, tachycardia, or flutter |
| Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey | Recruitment to 3 years | — |
| Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA | 1 month to 3 years | ATA include fibrillation, tachycardia, or flutter |
| Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3 | Recruitment to 3 years | — |
| Health economics and outcomes research assessed by number of hospitalization | Recruitment to 3 years | Includes total number of hospitalizations and unscheduled arrhythmia-related health care provider visits |
| Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures | 1 month to 3 years | — |
| Evaluating PV re-connection at redo procedure assessed by Lasso catheter | 3 months to 3 years | Visual inspection of electrograms on the Lasso catheter will be performed to verify durable PV isolation or re-connection |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristic assessed by history of implanted devices | At baseline | — |
| Clinical characteristic assessed by LA diameter measured by echocardiography | At baseline | — |
| Clinical characteristic assessed by LA volume measured by echocardiography | At baseline | — |
| Clinical characteristic assessed by cardiovascular medication history | At baseline | — |
| Procedure characteristic assessed by procedure time | At baseline | — |
| Clinical characteristic assessed by height | At baseline | — |
| Procedure characteristic assessed by fluoroscopy time | At baseline | — |
| Electrophysiological characteristic assessed by voltage mapping of the LA | At baseline | Point-by-point bipolar voltage mapping will be performed to quantify the amount of low voltage areas in the LA |
| Electrophysiological characteristic assessed by atrial refractoriness | At baseline | This will be done by premature stimulation protocol |
| Electrophysiological characteristic assessed by conduction velocity | At baseline | This will be done by premature stimulation protocol |
| Electrophysiological characteristic assessed by AF inducibility | At baseline | This will be done by premature stimulation protocol |
| Procedure characteristic assessed by radiofrequency time | At baseline | — |
| Clinical characteristic assessed by weight | At baseline | — |
| Clinical characteristic assessed by age | At baseline | — |
| Clinical characteristic assessed by sex | At baseline | — |
| Clinical characteristic assessed by congestive heart failure history | At baseline | — |
| Clinical characteristic assessed by hypertension history | At baseline | — |
| Clinical characteristic assessed by stroke/TIA/Thromboembolism history | At baseline | — |
| Clinical characteristic assessed by vascular disease history | At baseline | — |
| Clinical characteristic assessed by diabetes mellitus | At baseline | — |
| Clinical characteristic assessed by left ventricle ejection fraction (LVEF) | At baseline | — |
| Clinical characteristic assessed by structural heart disease | At baseline | — |
| Clinical characteristic assessed by endurance measured by amount of training/cycling per week | At baseline | — |
Countries
Belgium
Outcome results
None listed