HVP_Visitag Surpoint BWI

HVP Evaluation of VISITAG SURPOINTâ„¢ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and THERMOCOOL SMARTTOUCH® Catheters for pulmonary vein isolation (PVI)

Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINTâ„¢ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal.

Key Inclusion Criteria:

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 antiarrhythmic drugs) as evidenced by recurrent symptomatic AF, or intolerable to the AAD
Age 18 years or older and signed Patient Informed Consent Form (ICF)
Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Phase IV/V
NCT03624881
Heart and Vascular
Electrophysiology
Scott Brancato, M.D.
Biosense Webster
Sarah Grant
  • Providence St. Vincent Medical Center