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SMART-SF Radiofrequency Ablation Safety Study

NCT02359890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-02-04

Study results available
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Summary

This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).

Conditions

Interventions

DEVICE

THERMOCOOL® SMARTTOUCH® (RF ablation treatment)

Radiofrequency Ablation Treatment

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
2015-03-01
Primary Completion
2015-09-01
Completion
2016-11-08
FDA Device
Yes

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Entities

Diseases

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 NCT02359890 on ClinicalTrials.gov