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Procedure

TactiFlex SE for Atrial Fibrillation

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a special tool called the TactiFlex SE catheter that uses heat to treat patients with a type of irregular heartbeat that doesn't respond to medication. The tool works by creating small scars in the heart to stop abnormal signals and restore a normal heartbeat.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
Number of Participants With Device or Procedure-related Serious Adverse Events
Secondary study objectives
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs
KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Main StudyExperimental Treatment1 Intervention
Group II: High Standard Power Sub-StudyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TactiFlex SE - High Standard Power
2020
N/A
~360
TactiFlex SE
2020
N/A
~360

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
650 Previous Clinical Trials
410,991 Total Patients Enrolled
76 Trials studying Atrial Fibrillation
31,685 Patients Enrolled for Atrial Fibrillation
Kristin Ruffner, PhDStudy DirectorClinical Program Director
9 Previous Clinical Trials
10,635 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
750 Patients Enrolled for Atrial Fibrillation

Media Library

TactiFlex SE (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04356040 — N/A
Atrial Fibrillation Research Study Groups: Main Study, High Standard Power Sub-Study
Atrial Fibrillation Clinical Trial 2023: TactiFlex SE Highlights & Side Effects. Trial Name: NCT04356040 — N/A
TactiFlex SE (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04356040 — N/A
~67 spots leftby Nov 2025
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