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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

Study Summary

This trial is testing a new way to treat atrial fibrillation (AFib) by using high-powered ablation. The study will compare two groups of people, one receiving the new treatment and one receiving the standard treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
638 Previous Clinical Trials
403,833 Total Patients Enrolled
75 Trials studying Atrial Fibrillation
31,631 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial involve participants who are at least 18 years old?

"This clinical trial specifies that the minimum age for eligibility is 18, while participants can be up to 130 years old."

Answered by AI

Is enrollment currently available for this medical trial?

"According to the information listed on clinicaltrials.gov, this medical research has since concluded its recruitment process, having first been posted on June 29th 2020 and last updated July 8th 2022. However, there are still 476 other studies actively enrolling participants at present."

Answered by AI

Do I qualify to partake in this medical experiment?

"This medical experiment is recruiting 355 individuals between 18 and 130 years of age that are currently suffering from atrial fibrillation. To be eligible, they must have a physician's note confirming recurrent self-terminating AF episodes in the past 12 months, agree to all trial requirements and provide informed consent, not have active systemic infections or hypertrophic cardiomyopathy and possess documented evidence of an AF episode through either continuous ECG monitoring or 30 seconds on another device."

Answered by AI

What is the geographical extent of this clinical trial's management?

"Patients for this experiment can be found at Memorial Hermann Hospital in Houston, Texas, Kansas City Cardiac Arrhythmia Research Foundation in Overland Park, Kansas and Franciscan Heart & Vascular Associates in Tacoma Washington. There are also 20 other sites with available enrolment opportunities."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What site did they apply to?
Arkansas Heart Hospital
Memorial Hermann Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
2020. "TactiFlex Paroxysmal Atrial Fibrillation IDE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04356040.
~75 spots leftby Apr 2025
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