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A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:

NCT06676072 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2026-01-15

No results posted yet for this study

Summary

The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Conditions

  • Atrial Fibrillation (AF)
  • Atrial Arrhythmia
  • Paroxysmal AF
  • Drug Refractory Paroxysmal Atrial Fibrillation

Interventions

DEVICE

PFA Ablation catheter

Deliver RF and/or PF energy using the TactFlex PFA system

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Sarah Kammer · Abbott Medical Devices

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • Lithuania
  • Netherlands

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 NCT06676072 on ClinicalTrials.gov