Paroxysmal Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation
Brief summary
The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter. Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation lines is assessed. The study is a prospective, non-randomized, post-market clinical evaluation. Up to 330 patients will be included in this study. All patients who qualify based on the study specific requirements will be invited to participate. The total duration of the study is estimated to be about 24 months (12 months enrollment period and 12 months of follow up). The clinical investigation population include subjects undergoing RF ablation for treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical investigation, all subjects must meet the inclusion/exclusion criteria and are suitable candidates for enrollment in a clinical investigation in the opinion of the investigator. Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent or are intolerant of the AAD.
Interventions
DEVICERF ablation
RF ablation
Sponsors
Biosense Webster, Inc.
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. Symptomatic paroxysmal AF who had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), holter monitor or telemetry strip 2. Failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent symptomatic AF, or intolerance to the AAD 3. Age 18 years or older 4. Signed Patient Informed Consent Form (ICF) 5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 2. Previous LA ablation or surgery 3. Anticipated to receive ablation outside the PV ostia and CTI region 4. Previously diagnosed with persistent AF (\> 7 days in duration) 5. LA size \>50 mm 6. LA thrombus 7. LVEF \< 40% 8. Uncontrolled heart failure or NYHA Class III or IV 9. History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) 10. History of a documented thromboembolic event (including TIA) within the past 6 months 11. Previous PCI/MI within the past 3 months 12. Previous cardiac surgery (e.g. CABG) within the past 6 months 13. Previous valvular cardiac surgical/percutaneous procedure (e.g. ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve) 14. Unstable angina pectoris 15. Awaiting cardiac transplantation, cardiac surgery or other major surgery within the next 12 months. 16. Significant pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms 17. Acute illness, active systemic infection or sepsis 18. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation. 19. Presence of a condition that precludes vascular access 20. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial 21. Current enrollment in an investigational study evaluating another device or drug. 22. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 23. Life expectancy less than 12 months 24. Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of primary adverse events | 7 days | A Primary adverse event (PAE) is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of ablation index. |
| confirmation of entrance block | intraoperative | Presence/absence of acute reconnection will be evaluated through a 30 minute waiting period and adenosine challenge. PVs where acute reconnection is identified during the waiting period or following adenosine challenge will be considered ablation index false positives |
| long-term effectiveness | 12 months | Freedom from documented atrial arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL)) episodes (episodes ≥ 30 sec on arrhythmia monitoring device) during the effectiveness evaluation period (day 91-365) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of individual PAE versus total number of PAE | 12 months | Incidence of individual PAE versus total number of PAE occured during study |
| Incidence of entrance block after first encirclement (prior to 30-min waiting period) | intraoperative | % of subjects with ipsilateral PV isolation (entrance block) after first encirclement (evaluated prior to the 30 minute waiting period and adenosine challenge) |
| Long-term effectiveness: freedom from documented symptomatic atrial arrhythmia | from 3 up to 12 months | Freedom from documented symptomatic atrial arrhythmia (AF, AT and AFL) episodes (episodes ≥ 30 sec on arrhythmia monitoring device) during the effectiveness evaluation period (day 91-365) |
Countries
Austria, Belgium, Denmark, France, Ireland, Italy, Netherlands, Switzerland, United Kingdom
Outcome results
None listed