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Evaluation of the VISITAG SURPOINT? Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH? SF and the THERMOCOOL SMARTTOUCH? Catheters for Pulmonary Vein Isolation (PVI)

Study category: Heart and Blood Conditions

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Description

The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit.

Details
Age

Adult

Eligibility

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 Failed at least one antiarrhythmic drug (AAD) (Class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD

Detailed Eligibility: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 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) (Class I or III) as evidenced by recurrent symptomatic AF, or intolerable 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 Subjects who meet any of the following exclusion criteria are not eligible for enrollment. 1. Previous surgical or catheter ablation for atrial fibrillation 2. Previous cardiac surgery (including CABG) within the past 6 months (180 days) 3. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) 4. Any carotid stenting or endarterectomy 5. Documented LA thrombus on imaging 6. LA size > 50 mm on imaging 7. LVEF < 40% 8. Contraindication to anticoagulation (heparin or warfarin) 9. History of blood clotting or bleeding abnormalities 10. PCI/MI within the past 2 months (60 days) 11. Documented thromboembolic event (including TIA) within the past 12 months (365 days) 12. Rheumatic Heart Disease 13. Uncontrolled heart failure or NYHA function class III or IV 14. Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2) 15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 16. Unstable angina 17. Acute illness or active systemic infection or sepsis 18. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 19. Presence of implanted ICD/CRT-D. 20. 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. 21. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including OTC medication) 22. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. 23. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 24. Concurrent enrollment in an investigational study evaluating another device, biologic, or drug. 25. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes vascular access, or manipulation of the catheter. 26. Life expectancy less than 12 months

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Wendy Tzou,  MD

Wendy Tzou, MD

Study ID

Protocol Number: 19-0003

ClinicalTrials.gov: NCT03624881

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