NCT03459196

Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

Detailed description

The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures. The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	THERMOCOOL SMARTTOUCH SF-5D Catheter	radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-10-08
• Completion: 2018-10-08
• First posted: 2018-03-08
• Last updated: 2025-06-29
• Results posted: 2019-11-06

Locations

7 sites across 4 countries: Austria, Belgium, Czechia, Italy

Regulatory

• FDA-regulated device study