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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Active
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
PVI using the Arctic Front Cryoballoon (Medtronic)
PVI using the PolarX Cryoballoon (Boston Scientific)
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Symptomatic Paroxysmal Atrial Fibrillation, pulmonary vein isolation, cryoballoon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Basel
  • Inselspital, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PVI using the Arctic Front Cryoballoon (Medtronic)

PVI using the PolarX Cryoballoon (Boston Scientific)

Arm Description

Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)

Pulmonary vein isolation using the PolarX Cryoballoon (Boston Scientific)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Number of participants with complications
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
procedural endpoint
Total LA indwelling time
procedural endpoint
Total cryoablation time
procedural endpoint
Total number of cryoapplications per patient/per vein
procedural endpoint
Time to effect
disappearance of PV-Signal; procedural endpoint
Nadir temperatures
procedural endpoint
Total fluoroscopy time
procedural endpoint
Radiation dose
procedural endpoint
Contrast agent usage
unit measure ml; procedural endpoint
Proportion of veins with PV signals visible before cryoablation
procedural endpoint
Rate of Phrenic nerve palsy
procedural endpoint
Changes in high sensitive Troponin (hsTroponin)
one day 1 post-ablation ; procedural endpoint
Time to first symptomatic recurrence of atrial tachyarrhythmia
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
Follow up Endpoint.
Arrhythmia burden (daily AF burden [hours/day]; overall AF burden = % time in AF)
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)
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
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
based on telephone follow-up
Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias
based on telephone follow-up
Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias
based on telephone follow-up
Number of reconnected veins assessed in study patients undergoing a Redo-Procedure at one of the study centres
Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres
Size (area calculate in mm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres
Evolution of Quality of Life (QoL)
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

Full Information

First Posted
December 10, 2020
Last Updated
November 1, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04704986
Brief Title
Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
Acronym
COMPARE-CRYO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Symptomatic Paroxysmal Atrial Fibrillation, pulmonary vein isolation, cryoballoon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVI using the Arctic Front Cryoballoon (Medtronic)
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)
Arm Title
PVI using the PolarX Cryoballoon (Boston Scientific)
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation using the PolarX Cryoballoon (Boston Scientific)
Intervention Type
Device
Intervention Name(s)
PVI using the Arctic Front Cryoballoon (Medtronic)
Other Intervention Name(s)
Arctic Front Cryoballoon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PVI using the PolarX Cryoballoon (Boston Scientific)
Other Intervention Name(s)
PolarX Cryoballoon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to first recurrence of any atrial tachyarrhythmia
Description
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).
Time Frame
days 91 to 365 post-ablation
Secondary Outcome Measure Information:
Title
Number of participants with complications
Description
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
Time Frame
days 0 to 30 post-ablation
Title
Total procedure time
Description
procedural endpoint
Time Frame
Day 1
Title
Total LA indwelling time
Description
procedural endpoint
Time Frame
Day 1
Title
Total cryoablation time
Description
procedural endpoint
Time Frame
Day 1
Title
Total number of cryoapplications per patient/per vein
Description
procedural endpoint
Time Frame
Day 1
Title
Time to effect
Description
disappearance of PV-Signal; procedural endpoint
Time Frame
Day 1
Title
Nadir temperatures
Description
procedural endpoint
Time Frame
Day 1
Title
Total fluoroscopy time
Description
procedural endpoint
Time Frame
Day 1
Title
Radiation dose
Description
procedural endpoint
Time Frame
Day 1
Title
Contrast agent usage
Description
unit measure ml; procedural endpoint
Time Frame
Day 1
Title
Proportion of veins with PV signals visible before cryoablation
Description
procedural endpoint
Time Frame
Day 1
Title
Rate of Phrenic nerve palsy
Description
procedural endpoint
Time Frame
Day 1
Title
Changes in high sensitive Troponin (hsTroponin)
Description
one day 1 post-ablation ; procedural endpoint
Time Frame
Day 1
Title
Time to first symptomatic recurrence of atrial tachyarrhythmia
Description
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 Frame
between 91-365 days after ablation
Title
Time to first recurrence of atrial tachyarrhythmia
Description
Follow up Endpoint.
Time Frame
between days 1 and 90 after ablation
Title
Arrhythmia burden (daily AF burden [hours/day]; overall AF burden = % time in AF)
Description
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
Time Frame
between: 0-90 days; 91-365 days , 365 days up to 3.5 years
Title
Arrhythmia burden calculated for 7-day intervals (daily AF burden [hours/day]; overall AF burden = % time in AF)
Description
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.
Time Frame
3, 6 and 12 months follow up
Title
Comparison of the prevalence of the type of arrhythmia
Description
Arrhythmia being AF or organized atrial arrhythmias (Atrial flutter or atrial tachycardias). Follow up Endpoint.
Time Frame
3, 12, 24 and 36 months follow up
Title
Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias
Description
based on telephone follow-up
Time Frame
postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Title
Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias
Description
based on telephone follow-up
Time Frame
postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Title
Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias
Description
based on telephone follow-up
Time Frame
postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months)
Title
Number of reconnected veins assessed in study patients undergoing a Redo-Procedure at one of the study centres
Time Frame
during redo-procedure
Title
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
Title
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
Title
Evolution of Quality of Life (QoL)
Description
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
Time Frame
Months 3, 12, 24 and 36 post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Reichlin, MD
Organizational Affiliation
Inselspital, Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
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Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF

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