First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation

Summary

The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question\[s\] it aims to answer are:

* Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting \> 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF?
* Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF/AT burden, AF/AT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular;

* Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor,
* Regular echocardiographic exams for reverse atrial remodelling assessment,
* HRQoL questionnaires
* Assessment of cognitive function
* Atrial fibrillation evaluation regarding structured characterisation and AF progression/regression
* Assessment of Health care use and costs
* Safety

Conditions

• Atrial Fibrillation, Persistent

Interventions

DEVICE

Pulmonary vein isolation

Arctic Front™ Cryoballoon Advance, Medtronic, for pulmonary vein isolation

DRUG

dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™

Antiarrhythmic drugs

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• Erling-Persson Stiftelse

  collaborator UNKNOWN

• Swedish Heart Lung Foundation

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• Region Örebro County

  lead OTHER

Principal Investigators

• Carina M Blomstrom Lundqvist, MD, PhD · Faculty of Medicine and Health, Örebro University, and Uppsala University, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-21

Primary Completion

2027-12-31

Completion

2028-12-31

FDA Drug

Yes

FDA Device

Yes

Countries

• Hungary
• Slovakia
• Sweden
• United Kingdom

Study Locations