Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF

NCT04704986 | Active Not Recruiting Phase 4

• 1 other identifier: 2020-02076
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

Brief Summary

Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI. Currently, Medtronic Arctic Front cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel cryoballoon technology has recently been introduced (PolarX, Boston Scientific). However, whether PolarX provides effectiveness similar to the standard-of-practice Medtronic Arctic Front cryoballoon is yet to be investigated. Given that PolarX was developed considering the reported limitations and potential failures associated with the Medtronic Arctic Front cryoballoon, it might be even more effective and safe for use in AF ablation procedures. The aim of this trial is to compare the efficacy and safety of the PolarX Cryoballoon (Boston Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic paroxysmal AF undergoing their first PVI. This is an investigator-initiated, multicenter, randomized controlled, open-label trial with blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the standard-of-practice for single shot PVI and the PolarX is the novel technology, this trial has a non-inferiority design. The hypothesis with regards to the primary efficacy endpoint is that the PolarX Cryoballoon (Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic) and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91 and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first PVI. Hence the alternative hypothesis postulates that the PolarX Cryoballoon is non-inferior to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude non-inferiority.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Symptomatic Paroxysmal Atrial Fibrillation; pulmonary vein isolation; cryoballoon

Outcome Measures

Primary Outcomes (1)

• Time to first recurrence of any atrial tachyarrhythmia

  Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval).

  days 91 to 365 post-ablation

Secondary Outcomes (25)

• Number of participants with complications

  days 0 to 30 post-ablation

• Total procedure time

  Day 1

• Total LA indwelling time

  Day 1

• Total cryoablation time

  Day 1

• Total number of cryoapplications per patient/per vein

  Day 1

Study Arms (2)

PVI using the Arctic Front Cryoballoon (Medtronic)

ACTIVE COMPARATOR

Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)

Device: PVI using the Arctic Front Cryoballoon (Medtronic)

PVI using the PolarX Cryoballoon (Boston Scientific)

ACTIVE COMPARATOR

Pulmonary vein isolation using the PolarX Cryoballoon (Boston Scientific)

Drug: PVI using the PolarX Cryoballoon (Boston Scientific)

Interventions

PVI using the Arctic Front Cryoballoon (Medtronic) DEVICE

Patients randomized to the Arctic Front cryoballoon group will undergo PVI using the Arctic Front Cryoballoon (Medtronic). At the end of the procedure, an implantable cardiac monitor (Medtronic Reveal LINQ) will be implanted for the purpose of continuous arrhythmia monitoring.

Also known as: Arctic Front Cryoballoon

PVI using the Arctic Front Cryoballoon (Medtronic)

PVI using the PolarX Cryoballoon (Boston Scientific) DRUG

Patients randomized to PolarX cryoballoon group will undergo PVI using the PolarX Cryoballoon (Boston Scientific). At the end of the procedure, an implantable cardiac monitor (Medtronic Reveal LINQ) will be implanted for the purpose of continuous arrhythmia monitoring.

Also known as: PolarX Cryoballoon

PVI using the PolarX Cryoballoon (Boston Scientific)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal atrial fibrillation documented on a 12 lead electrocardiogram (ECG) or Holter monitor (lasting ≥30 seconds) within the last 24 months. According to current guidelines, paroxysmal is defined as any atrial fibrillation (AF) that converts to sinus rhythm within 7 days either spontaneously or by pharmacological or electrical cardioversion.
• Candidate for ablation based on current AF guidelines
• Continuous anticoagulation with warfarin (International Normalized Ratio \[INR\] 2-3) or a novel oral anticoagulant (NOAC) for ≥4 weeks prior to the ablation; or a transesophageal echocardiogram (TEE) that excludes left atrial (LA) thrombus ≤48 hours before ablation
• Age of 18 years or older on the date of consent
• Informed Consent as documented by signature (Appendix Informed Consent Form)

You may not qualify if:

• Previous LA ablation or LA surgery
• AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
• Intracardiac thrombus
• Pre-existing pulmonary vein stenosis or pulmonary vein stent
• Pre-existing hemidiaphragmatic paralysis
• Contraindication to anticoagulation or radiocontrast materials
• Cardiac valve prosthesis
• Clinically significant (moderately-severe or severe) mitral regurgitation or stenosis
• Myocardial infarction, percutaneous coronary intervention (PCI)/ percutaneous transluminal coronary angioplasty (PTCA), or coronary artery stenting during the 3-month period preceding the consent date
• Cardiac surgery during the three-month interval preceding the consent date or scheduled cardiac surgery/transcatheter aortic valve implantation (TAVI) procedure
• Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including patent foramen ovale)
• New York Heart Association (NYHA) class III or IV congestive heart failure
• Left ventricular ejection fraction (LVEF) \<35%
• Hypertrophic cardiomyopathy (wall thickness \>1.5 cm)
• Significant chronic kidney disease (CKD; estimated glomerular filtration rate \[eGFR\] \<30 μMol/L)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (2)

University Hospital Basel

Basel, 4031, Switzerland

Location

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias Reichlin, MD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: January 12, 2021
• Study Start: March 29, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)