RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-03-09
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05462145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A diagnosis of recurrent symptomatic paroxysmal or persistent AF
  2. * Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
  1. * Long-standing persistent AF (sustained \>12 months)
  2. * Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
  3. * History of thromboembolic events within the past six months
  4. * Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
  5. * Any cardiac surgery within the previous six months
  6. * Prior left atrial ablation or surgical procedure
  7. * Presence of an implanted cardiac device
  8. * Body mass index (BMI) \>40 kg/m\^2
  9. * Left ventricular ejection fraction (LVEF) \<35%
  10. * Anterior-posterior left atrial (LA) diameter \>55mm

Contacts and Locations

Study Contact

Clinical Affairs
CONTACT
+1 (604) 248 8891
Clinical.Affairs@kardium.com

Study Locations (Sites)

University of Alabama Heersink School of Medicine
Birmingham, Alabama, 35233
United States
Grandview Medical Center
Birmingham, Alabama, 35243
United States
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
United States
Sutter Health - California Pacific Medical Center
San Francisco, California, 94109
United States
St. Vincent's Medical Center
Jacksonville, Florida, 32204
United States
Mercy Hospital
Miami, Florida, 33133
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Mt. Sinai Hospital, Guggenheim Pavilion
New York, New York, 10029
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Kardium Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-09
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-03-09
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Pulsed Field Ablation
  • Irreversible Electroporation

Additional Relevant MeSH Terms

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation