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TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

NCT04356040 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2023-10-31

Study results available
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Summary

Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

TactiFlex SE

Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.

DEVICE

TactiFlex SE - High Standard Power

Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kristin Ruffner, PhD · Clinical Program Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2022-07-01
Completion
2022-07-01
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Taiwan

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 NCT04356040 on ClinicalTrials.gov