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Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation (PULSAR)

Primary Purpose

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Globe Pulsed Field System
Sponsored by
Kardium Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Pulsed Field Ablation, Irreversible Electroporation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key inclusion criteria:

  • A diagnosis of recurrent symptomatic paroxysmal or persistent AF
  • Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

  • Long-standing persistent AF (sustained >12 months)
  • Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
  • History of thromboembolic events within the past six months
  • Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
  • Any cardiac surgery or coronary artery stenting within the last two months
  • Prior left atrial ablation or surgical procedure
  • Open heart surgery within the previous six months
  • Presence of an implanted cardiac device
  • Body mass index (BMI) >40 kg/m^2
  • Left ventricular ejection fraction (LVEF) <35%
  • Anterior-posterior left atrial (LA) diameter >55mm

Sites / Locations

  • University of Alabama Heersink School of Medicine
  • St. Bernards Medical CenterRecruiting
  • Sutter Health - California Pacific Medical Center
  • St. Vincent's Medical CenterRecruiting
  • Mercy Hospital
  • Johns Hopkins
  • Massachusetts General Hospital
  • Beaumont Hospital
  • Mt. Sinai Hospital, Guggenheim PavilionRecruiting
  • Cleveland Clinic
  • Hospital of the University of Pennsylvania
  • St.Paul's Hospital
  • McGill University Health Centre
  • Nemocnice Na HomolceRecruiting
  • Heart and Diabetes Center NRW
  • Westpfalz-Klinikum GmbH KaiserslauternRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Globe Pulsed Field System

Arm Description

Outcomes

Primary Outcome Measures

Effectiveness endpoint
Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Safety endpoint
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2022
Last Updated
October 20, 2023
Sponsor
Kardium Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05462145
Brief Title
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Acronym
PULSAR
Official Title
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kardium Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords
Pulsed Field Ablation, Irreversible Electroporation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
449 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Globe Pulsed Field System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Globe Pulsed Field System
Intervention Description
Ablation and atrial mapping with the Globe Pulsed Field System
Primary Outcome Measure Information:
Title
Effectiveness endpoint
Description
Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Time Frame
12 months
Title
Safety endpoint
Description
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria: A diagnosis of recurrent symptomatic paroxysmal or persistent AF Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III Key exclusion criteria: Long-standing persistent AF (sustained >12 months) Atrial fibrillation secondary to a reversible cause or of non-cardiac origin History of thromboembolic events within the past six months Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months Any cardiac surgery within the previous six months Prior left atrial ablation or surgical procedure Presence of an implanted cardiac device Body mass index (BMI) >40 kg/m^2 Left ventricular ejection fraction (LVEF) <35% Anterior-posterior left atrial (LA) diameter >55mm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Affairs
Phone
+1 (604) 248 8891
Email
Clinical.Affairs@kardium.com
Facility Information:
Facility Name
University of Alabama Heersink School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
University of Alabama Heersink School of Medicine 625 19th Street South, AL, 35233, USA
Facility Name
St. Bernards Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
St. Bernards Medical Center 201 East Oak Avenue, AR 72401, USA
Facility Name
Sutter Health - California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sutter Health CPMC 1101 Van Ness Ave, CA, 94109, USA
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
St. Vincent's Medical Center 1 Shircliff Way, FL 32204, USA
Facility Name
Mercy Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercy Hospital 3663 S. Miami Ave, FL, 33133, USA
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johns Hopkins 1800 Orleans Street, MD 21287, USA
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massachusetts General Hospital 55 Fruit Street, MA 02114, USA
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beaumont Hospital 3601 West 13 Mile Road, MI 48073, USA
Facility Name
Mt. Sinai Hospital, Guggenheim Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mt. Sinai Hospital 1190 Fifth Avenue - 1 South, NY 10029, USA
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cleveland Clinic 9500 Eucid Ave, OH, 44195, USA
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hospital of the University of Pennsylvania 1 Convention Ave, PA, 19104, USA
Facility Name
St.Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
St.Paul's Hospital 1033 Davie Street, BC, V6E 1M7, Canada
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
McGill University Health Centre 1001 Decarie Boulevard, QC, H4A 3J1 Canada
Facility Name
Nemocnice Na Homolce
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nemocnice Na Homolce Roentgenova 37/2, 150 30 Praha 5 - Motol, Czech Republic
Facility Name
Heart and Diabetes Center NRW
City
Bad Oeynhausen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heart and Diabetes Center NRW Georgstraße 11, 32545 Bad Oeynhausen, Germany
Facility Name
Westpfalz-Klinikum GmbH Kaiserslautern
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Westpfalz-Klinikum GmbH Kaiserslautern Hellmut-Hartert-Straße 1, Kaiserslautern, 67655, Germany

12. IPD Sharing Statement

Learn more about this trial

Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

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