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Procedure

Medtronic PulseSelect Pulsed Field Ablation (PFA) System for Atrial Fibrillation (PULSED AF Trial)

N/A
Waitlist Available
Led By Atul Verma, MD
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
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 up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of the PulseSelect™ PFA System, a device that uses electrical pulses to treat patients with atrial fibrillation by isolating certain veins in the heart. The device works by creating small scars that block abnormal signals, helping to restore a normal heart rhythm. Pulsed field ablation (PFA) is a new feasible and safe method for the treatment of irregular heartbeats, such as atrial fibrillation (AF).

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Effectiveness: Number of Participants With Treatment Success.
Safety: Number of Participants With at Least One Primary Safety Event
Secondary study objectives
Quality of Life - Change in AFEQT Score
Quality of Life - Change in EQ-5D Score
Other study objectives
Pilot Phase Effectiveness: Number of Participants With Acute Procedural Success of PVI Ablation With the PFA System.
Pilot Phase Safety: Number of Participants With a PFA System-related and PFA Procedure-related Serious Adverse Event (SAE) Within 30 Days Post-ablation.

Awards & Highlights

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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Pivotal - Roll-InExperimental Treatment1 Intervention
First patient treated by each physician in the pivotal phase.
Group II: Pivotal - Persistent AFExperimental Treatment1 Intervention
Non roll-in patients with persistent AF (AF that lasts longer than 7 days).
Group III: Pivotal - Paroxysmal AFExperimental Treatment1 Intervention
Non roll-in patients with paroxysmal AF (intermittent AF).
Group IV: PilotExperimental Treatment1 Intervention
First group of patients enrolled in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medtronic PulseSelect Pulsed Field Ablation (PFA) System
2019
N/A
~430

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Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
202 Previous Clinical Trials
135,591 Total Patients Enrolled
44 Trials studying Atrial Fibrillation
21,899 Patients Enrolled for Atrial Fibrillation
Atul Verma, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
12 Previous Clinical Trials
2,671 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
2,646 Patients Enrolled for Atrial Fibrillation
~72 spots leftby Nov 2025
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