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Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF (COMPARE-CRYO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04704986
Recruitment Status : Active, not recruiting
First Posted : January 12, 2021
Last Update Posted : February 29, 2024
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Insel Gruppe AG, University Hospital Bern

Tracking Information
First Submitted Date  ICMJE December 10, 2020
First Posted Date  ICMJE January 12, 2021
Last Update Posted Date February 29, 2024
Actual Study Start Date  ICMJE March 29, 2021
Actual Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2021)		 Time to first recurrence of any atrial tachyarrhythmia [ Time Frame: days 91 to 365 post-ablation ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2021)
  • Number of participants with complications [ Time Frame: days 0 to 30 post-ablation ]
    Composite endpoint composed of:
    • cardiac tamponade requiring drainage
    • persistent phrenic nerve palsy lasting >24 hours
    • serious vascular complications requiring intervention
    • stroke/TIA
    • atrioesophageal fistula
    • death
  • Total procedure time [ Time Frame: Day 1 ]
    procedural endpoint
  • Total LA indwelling time [ Time Frame: Day 1 ]
    procedural endpoint
  • Total cryoablation time [ Time Frame: Day 1 ]
    procedural endpoint
  • Total number of cryoapplications per patient/per vein [ Time Frame: Day 1 ]
    procedural endpoint
  • Time to effect [ Time Frame: Day 1 ]
    disappearance of PV-Signal; procedural endpoint
  • Nadir temperatures [ Time Frame: Day 1 ]
    procedural endpoint
  • Total fluoroscopy time [ Time Frame: Day 1 ]
    procedural endpoint
  • Radiation dose [ Time Frame: Day 1 ]
    procedural endpoint
  • Contrast agent usage [ Time Frame: Day 1 ]
    unit measure ml; procedural endpoint
  • Proportion of veins with PV signals visible before cryoablation [ Time Frame: Day 1 ]
    procedural endpoint
  • Rate of Phrenic nerve palsy [ Time Frame: Day 1 ]
    procedural endpoint
  • Changes in high sensitive Troponin (hsTroponin) [ Time Frame: Day 1 ]
    one day 1 post-ablation ; procedural endpoint
  • Time to first symptomatic recurrence of atrial tachyarrhythmia [ Time Frame: between 91-365 days after ablation ]
    Assessed by the ICM Core Lab. "Symptomatic" is defined as acute onset awareness of palpitations, breathlessness, dizziness, fatigue or chest pain associated with patient activation of the loop recorder. Follow up Endpoint.
  • Time to first recurrence of atrial tachyarrhythmia [ Time Frame: between days 1 and 90 after ablation ]
    Follow up Endpoint.
  • Arrhythmia burden (daily AF burden [hours/day]; overall AF burden = % time in AF) [ Time Frame: between: 0-90 days; 91-365 days , 365 days up to 3.5 years ]
    Assessed by the ICM Core Lab post implantation: between 0-90 days; 91-365 days, 365 days to explantation/end of life of the ICM
  • Arrhythmia burden calculated for 7-day intervals (daily AF burden [hours/day]; overall AF burden = % time in AF) [ Time Frame: 3, 6 and 12 months follow up ]
    Comparison of full-duration ICM derived endpoints with standard clinical practice derived endpoints. Standard clinical practice being defined as 7d-Holter Periods after 3, 6 and 12 months (modelled with random 7day ICM periods after 3, 6 and 12 months). Follow up Endpoint.
  • Comparison of the prevalence of the type of arrhythmia [ Time Frame: 3, 12, 24 and 36 months follow up ]
    Arrhythmia being AF or organized atrial arrhythmias (Atrial flutter or atrial tachycardias). Follow up Endpoint.
  • Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias [ Time Frame: postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months) ]
    based on telephone follow-up
  • Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias [ Time Frame: postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months) ]
    based on telephone follow-up
  • Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias [ Time Frame: postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months) ]
    based on telephone follow-up
  • Number of reconnected veins assessed in study patients undergoing a Redo-Procedure at one of the study centres [ Time Frame: during redo-procedure ]
  • Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres [ Time Frame: during redo-procedure ]
  • Size (area calculate in mm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres [ Time Frame: during redo-procedure ]
  • Evolution of Quality of Life (QoL) [ Time Frame: Months 3, 12, 24 and 36 post procedure ]
    QoL questionnaires (EQ-5D) will be sent to the patients by mail after 3, 12, 24 and 36 months to compare the evolution of QoL after the ablation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
Official Title  ICMJE Comparison of the PolarX and the Arctic Front Cryoballoon for Pulmonary Vein Isolation in Patients With Symptomatic Paroxysmal Atrial Fibrillation - A Multi-Center Non-Inferiority Design Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE
  • Device: PVI using the Arctic Front Cryoballoon (Medtronic)

    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.

    Other Name: Arctic Front Cryoballoon
  • Drug: PVI using the PolarX Cryoballoon (Boston Scientific)

    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.

    Other Name: PolarX Cryoballoon
Study Arms  ICMJE
  • Active Comparator: PVI using the Arctic Front Cryoballoon (Medtronic)
    Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)
    Intervention: Device: PVI using the Arctic Front Cryoballoon (Medtronic)
  • Active Comparator: PVI using the PolarX Cryoballoon (Boston Scientific)
    Pulmonary vein isolation using the PolarX Cryoballoon (Boston Scientific)
    Intervention: Drug: PVI using the PolarX Cryoballoon (Boston Scientific)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 1, 2022)		 201
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2021)		 200
Estimated Study Completion Date  ICMJE July 31, 2025
Actual Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • Uncontrolled hyperthyroidism
  • Cerebral ischemic event (stroke or TIA) during the six-month interval preceding the consent date
  • Ongoing systemic infections
  • History of cryoglobulinemia
  • Pregnancy*
  • Life expectancy less than one (1) year per physician opinion
  • Currently participating in any other clinical trial of a drug, device or biological material during the duration of this study.

  • Unwilling or unable to comply fully with study procedures and follow-up.

    • To exclude pregnancy a blood test (human chorionic gonadotropin [HCG]) is used.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04704986
Other Study ID Numbers  ICMJE 2020-02076
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Insel Gruppe AG, University Hospital Bern
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Insel Gruppe AG, University Hospital Bern
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University Hospital, Basel, Switzerland
Investigators  ICMJE
Principal Investigator: Tobias Reichlin, MD Inselspital, Bern University Hospital
PRS Account Insel Gruppe AG, University Hospital Bern
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP