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Volt PFA Catheter Sensor Enabled (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 clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

Eligible Conditions
  • Atrial Fibrillation
  • Atrial Arrhythmias

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
Longterm Effectiveness
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System.
Secondary study objectives
AAD-Free Effectiveness
Symptomatic Effectiveness

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Volt PFA Catheter Sensor Enabled (SE)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
649 Previous Clinical Trials
410,711 Total Patients Enrolled
76 Trials studying Atrial Fibrillation
31,605 Patients Enrolled for Atrial Fibrillation
Sarah KammerStudy DirectorAbbott
Kristin RuffnerStudy DirectorAbbott
3 Previous Clinical Trials
582 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
582 Patients Enrolled for Atrial Fibrillation
~290 spots leftby Jan 2026
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