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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.

NCT03459196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-06-29

Study results available
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Summary

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

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

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

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2018-10-08
Completion
2018-10-08
FDA Device
Yes

Countries

  • Austria
  • Belgium
  • Czechia
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459196 on ClinicalTrials.gov