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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
Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment OR physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

PULSED AF Trial Summary

This trial is looking at the safety and effectiveness of a new device to treat atrial fibrillation. The device is being studied in two phases, with the aim of providing data to show its safety and effectiveness.

PULSED AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment.

PULSED AF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness: Number of Participants With Treatment Success.
Safety: Number of Participants With at Least One Primary Safety Event
Secondary outcome measures
Quality of Life - Change in AFEQT Score
Quality of Life - Change in EQ-5D Score
Other outcome measures
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.

PULSED AF 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

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
198 Previous Clinical Trials
131,861 Total Patients Enrolled
42 Trials studying Atrial Fibrillation
24,846 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

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
What site did they apply to?
Providence Saint Vincent Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I would like to get a Pulse Field Ablation for Persistent Atrial Fibrillation.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Providence Saint Vincent Medical Center: < 48 hours
Average response time
  • < 2 Days
~80 spots leftby Mar 2025