Comparison of Available Standard Pulse Field Ablation Methods for Pulmonary Vein Isolation for Treatment of Atrial Fibrillation (PVI-MODE)

Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation

The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark.

A cluster randomization study tests standardized treatments by rotating the treatments over time periods. All patients will be treated with the specific standard treatment of the period and will be informed about the study. The patient will have the option to decline their participatiion in the study in writing and their data will not be collected.

The main purpose of the study is to investigate whether one of more of the systems are more efficient in preventing AF or atrial flutter during the following 12 months. Additionally, the safety of the systems are compared to see if one or more are more efficient in preventing complications 30 days after the ablation procedure.

The patients will receive standard treatment according to the cluster at the time of their ablation and data for up to 12 months post procedure will be collected by medicial chart review.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Pulse field ablation Systems

• Study Type: Interventional
• Enrollment (Estimated): 1125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter K Jacobsen, MD, DMSc; Phone Number: 35456752; Email: Peter.Karl.Jacobsen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
    • Contact: Peter K Jacobsen, MD; Phone Number: 35456752; Email: dketik@dketik.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• Planned Catheter Ablation of Atrial Fibrillation with Pulmonary Vein Isolation

Exclusion Criteria:

- Opt out of data collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FARAPULSE and FARAVIEW; PFA system	Device: Pulse field ablation Systems; Pulse field ablation Systems
Active Comparator: VARIPULSE; PFA system	Device: Pulse field ablation Systems; Pulse field ablation Systems
Active Comparator: PULSE-SELECT and AFFERA; PFA system	Device: Pulse field ablation Systems; Pulse field ablation Systems
Active Comparator: Arctic Front Advance Cardiac Cryoablation Catheter; Ablation system	Device: Pulse field ablation Systems; Pulse field ablation Systems
Active Comparator: VOLT; PFA system	Device: Pulse field ablation Systems; Pulse field ablation Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation or atrial flutter	Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)	12 months post procedure
Atrial fibrillation or atrial flutter	Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)	6 months post procedure
Atrial fibrillation or atrial flutter	Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)	3 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization due to atrial fibrillation or flutter	Hospitalization due to atrial fibrillation or flutter including DC cardioversion	12 months post procedure
Hospitalization due to atrial fibrillation or flutter	Hospitalization due to atrial fibrillation or flutter including DC cardioversion	6 months post procedure
Patient reported outcome measures	Patient reported symptoms and quality of life (Questionnaires)	12 month
Patient reported outcomes measures	Patient reported symptoms and quality of life (Questionnaires)	6 month
Patient reported outcomes measures	Patient reported symptoms and quality of life (Questionnaires)	3 month
Antiarrhythmic medications	Use of antiarrhythmic medications	12 months post procedure
Antiarrhythmic medications	Use of antiarrhythmic medications	6 months post procedure
Duration of the procedure	The duration of the ablation procedure	Post procedure
Safety of the system	The frequency of procedure-related complications	30 days post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resources and costs	Total costs of treatment (Hospitalization, DC-conversiton, medication and procedure-related costs) in Euros	12 month

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Peter K Jacobsen, MD, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Ablation; AF; pulmonary vein isolation; PVI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PVI-MODE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No