Trials / Completed

CompletedNCT02817776

Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 381 (actual)

Sponsor: Biosense Webster, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Detailed description

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and radio frequency (RF) ablation procedures.

Conditions

Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	THERMOCOOL SMARTTOUCH® SF catheter	Radiofrequency Ablation

Timeline

Start date: 2016-06-01
Primary completion: 2019-06-05
Completion: 2019-06-05
First posted: 2016-06-29
Last updated: 2025-02-04
Results posted: 2021-01-12

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT02817776. Inclusion in this directory is not an endorsement.