Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07456540

Comparison of Available Standard Pulse Field Ablation Methods for Pulmonary Vein Isolation for 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Opt out of data collection

Treatment and study plan

Pulse field ablation Systems

Device

Pulse field ablation Systems

Primary outcomes

  1. Atrial fibrillation or atrial flutter

    Time frame: 12 months post procedure

    Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)

  2. Atrial fibrillation or atrial flutter

    Time frame: 6 months post procedure

    Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)

  3. Atrial fibrillation or atrial flutter

    Time frame: 3 months post procedure

    Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)

Secondary outcomes

  1. Hospitalization due to atrial fibrillation or flutter

    Time frame: 12 months post procedure

    Hospitalization due to atrial fibrillation or flutter including DC cardioversion

  2. Hospitalization due to atrial fibrillation or flutter

    Time frame: 6 months post procedure

    Hospitalization due to atrial fibrillation or flutter including DC cardioversion

  3. Patient reported outcome measures

    Time frame: 12 month

    Patient reported symptoms and quality of life (Questionnaires)

  4. Patient reported outcomes measures

    Time frame: 6 month

    Patient reported symptoms and quality of life (Questionnaires)

  5. Patient reported outcomes measures

    Time frame: 3 month

    Patient reported symptoms and quality of life (Questionnaires)

  6. Antiarrhythmic medications

    Time frame: 12 months post procedure

    Use of antiarrhythmic medications

  7. Antiarrhythmic medications

    Time frame: 6 months post procedure

    Use of antiarrhythmic medications

  8. Duration of the procedure

    Time frame: Post procedure

    The duration of the ablation procedure

  9. Safety of the system

    Time frame: 30 days post procedure

    The frequency of procedure-related complications

Other outcomes

  1. Resources and costs

    Time frame: 12 month

    Total costs of treatment (Hospitalization, DC-conversiton, medication and procedure-related costs) in Euros

Study contacts

Contact information is provided by the study sponsor or research team.

Peter K Jacobsen, MD, DMSc

CONTACT

[email protected]

35456752

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: PVI-MODE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.