Recruiting

Globe PF System

Sponsor:

Kardium Inc.

Code:

NCT07651852

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Globe Pulsed Field System

Study Details

Brief summary:

This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).

Conditions

Atrial Fibrillation

Study ID

NCT07651852

Start date

Oct 9, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Patients with a planned ablation procedure using the commercially available Globe PF System

Key Exclusion Criteria:

  • Patients whose life expectancy is 1 year or less
  • Contraindication to left atrial catheter ablation or PF ablation
  • Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Globe Pulsed Field System

Interventions

Globe Pulsed Field System

Ablation and atrial mapping with the Globe Pulsed Field System

Primary outcome measure

  • Effectiveness endpoint [ Time Frame: 12 months ]
  • Safety endpoint [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Clinical Affairs

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

Locations

Arrhythmia Research Group

Recruiting

Jonesboro, Arkansas, United States, 72401

Principal Investigator:

Devi Nair, MD

Overlake Hospital

Recruiting

Bellevue, Washington, United States, 98004

Principal Investigator:

Maheer Gandhavadi, MD

More Information

Sponsor

Kardium Inc.

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Kardium Inc. on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.