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)

Recruiting
99 years or below
All
49 participants needed
1 Location

Brief description of study

This is a single-arm trial design for Biosense Webster's post-marketing study evaluating the effectiveness and safety of VISITAG SURPOINT Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF catheter (STSF)catheter for pulmonary vein isolation (PVI). The trial will enroll total of 330 subjects, to achieve a minimum of 250 subjects undergoing study catheter insertion with STSF catheter and 50 subjects with ST catheter for the analysis and to cover up to 30 subjects who could be lost to follow-up.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pulmonary Vein Isolation, PVI
  • Age: 99 years or below
  • Gender: All
Updated on 19 Feb 2024. Study ID: 831667

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