Back to resultsComparison of Cryoballoon vs. Pulsed Field Ablation in Patients With Symptomatic Paroxysmal Atrial Fibrillation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
PVI using the Arctic Front Cryoballoon (Medtronic)
PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Pulmonary vein isolation, Cryoballoon, Pulsed field ablation
Eligibility Criteria
Inclusion Criteria:
- Paroxysmal atrial fibrillation documented on a 12 lead ECG or Holter monitor (lasting ≥30 seconds) within the last 24 months. According to current guidelines, paroxysmal is defined as any 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 Vitamin-K-Antagonists or a novel oral anticoagulant for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or computer tomography 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
Exclusion Criteria:
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- Intracardiac thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Prior mitral valve surgery
- Severe mitral regurgitation or moderate/severe mitral stenosis
- Myocardial infarction during the 3-month period preceding the consent date
- Ongoing triple therapy
- Cardiac surgery during the three-month interval preceding the consent date or scheduled cardiac surgery/TAVI procedure
- Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- 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; eGFR <30 ml/min)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (stroke or TIA) during the six-month interval preceding the consent date
- Ongoing systemic infections
- History of cryoglobulinemia
- Cardiac amyloidosis
- Pregnancy
- Life expectancy less than one (1) year per physician opinion
- Currently participating in any other clinical trial, which may confound the results of this trial.
- Unwilling or unable to comply fully with study procedures and follow-up.
Sites / Locations
- University Hospital BaselRecruiting
- Inselspital, Bern University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arctic Front Cryoballoon (Medtronic)
Pulsed Field Ablation (FARAPULSE)
Arm Description
Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)
Pulmonary vein isolation using the FARAPULSE PFA system (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 safety 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 left atrium indwelling time
Procedural endpoint
Total fluoroscopy time
Procedural endpoint
Total radiation dose
Procedural endpoint
Contrast agent usage
Procedural endpoint
Increase in hsTroponin on day 1 post-ablation
Procedural endpoint
Proportion of isolated veins
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Proportion of isolated carinas
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Lesion size
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Time to first recurrence of atrial tachyarrhythmia between days 1 and 90 after ablation
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 1 and 90 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).
Arrhythmia burden evaluated based on continuous ICM (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 being AF or organized atrial arrhythmias (atrial flutter or atrial tachycardias)
Comparison of the prevalence of the type of arrhythmia recurrences during follow-up being AF or organized atrial arrhythmias (AFL or AT)
Average heart rates
Average heart rates in ICM documentation in months 1, 2 and 3 after ablation
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
Reinitiation of antiarrhythmic drugs during follow-up
Reinitiation of antiarrhythmic drugs during follow-up based on telephone follow-up
Number of reconnected veins evaluated during redo-procedures
Evolution of Quality of Life through months 3 and 12
QoL questionnaires (EQ-5D) will be sent to the patients by mail after 3 and 12 months to compare the evolution of QoL after the ablation
Stroke including TIA after 3, 12, 24 and 36 months
Death cardiovascular or non-cardiovascular after 3, 12, 24 and 36 months
Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres
Size (area calculate in cm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres
Full Information
NCT ID
NCT05534581
First Posted
August 22, 2022
Last Updated
October 3, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
1. Study Identification
Unique Protocol Identification Number
NCT05534581
Brief Title
Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients With Symptomatic Paroxysmal Atrial Fibrillation
Official Title
Single Shot Pulmonary Vein Isolation: Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients With Symptomatic Paroxysmal Atrial Fibrillation - A Multi-Center Non-Inferiority Design Clinical Trial (The SINGLE SHOT CHAMPION Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Currently, Medtronic Arctic Front Cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel method, pulse-field ablation (PFA) using the FARAPULSE catheter, has recently been introduced (FARAPULSE PFA, Boston Scientific). However, whether FARAPULSE PFA provides effectiveness similar to the standard-of-practice Medtronic Arctic Front Cryoballoon is yet to be investigated. Given that FARAPULSE PFA has shown in studies not to cause any of the severe complications reported in association with traditional PVI while being highly effective, it might be even safer and more effective for use in AF ablation procedures.
The aim of this trial is to compare the efficacy and safety of PVI using FARAPULSE PFA (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 PVI and the FARAPULSE PFA is the novel technology, this trial has a non-inferiority design.
The null hypothesis with regards to the primary efficacy endpoint is that the FARAPULSE PFA (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 FARAPULSE PFA 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
Pulmonary vein isolation, Cryoballoon, Pulsed field ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arctic Front Cryoballoon (Medtronic)
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)
Arm Title
Pulsed Field Ablation (FARAPULSE)
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation using the FARAPULSE PFA system (Boston Scientific)
Intervention Type
Device
Intervention Name(s)
PVI using the Arctic Front Cryoballoon (Medtronic)
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 will be implanted for the purpose of continuous arrhythmia monitoring.
Intervention Type
Device
Intervention Name(s)
PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)
Intervention Description
Patients randomized to the Pulsed Field Ablation group will undergo PVI using the FARAPULSE PFA system (Boston Scientific). At the end of the procedure, an implantable cardiac monitor 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 safety 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 0
Title
Total left atrium indwelling time
Description
Procedural endpoint
Time Frame
Day 0
Title
Total fluoroscopy time
Description
Procedural endpoint
Time Frame
day 0
Title
Total radiation dose
Description
Procedural endpoint
Time Frame
Day 0
Title
Contrast agent usage
Description
Procedural endpoint
Time Frame
Day 0
Title
Increase in hsTroponin on day 1 post-ablation
Description
Procedural endpoint
Time Frame
Day 1
Title
Proportion of isolated veins
Description
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Time Frame
Day 0
Title
Proportion of isolated carinas
Description
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Time Frame
Day 0
Title
Lesion size
Description
Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group
Time Frame
Day 0
Title
Time to first recurrence of atrial tachyarrhythmia between days 1 and 90 after ablation
Description
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 1 and 90 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 1 to 90 post-ablation
Title
Arrhythmia burden evaluated based on continuous ICM (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 being AF or organized atrial arrhythmias (atrial flutter or atrial tachycardias)
Description
Comparison of the prevalence of the type of arrhythmia recurrences during follow-up being AF or organized atrial arrhythmias (AFL or AT)
Time Frame
3, 12, 24 and 36 months follow up
Title
Average heart rates
Description
Average heart rates in ICM documentation in months 1, 2 and 3 after ablation
Time Frame
Months 1, 2 and 3 post-ablation
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
Reinitiation of antiarrhythmic drugs during follow-up
Description
Reinitiation of antiarrhythmic drugs during follow-up based on telephone follow-up
Time Frame
Months 3, 12, 24 and 36 post-ablation
Title
Number of reconnected veins evaluated during redo-procedures
Time Frame
During redo-procedure, expected to be on average 20-60 minutes
Title
Evolution of Quality of Life through months 3 and 12
Description
QoL questionnaires (EQ-5D) will be sent to the patients by mail after 3 and 12 months to compare the evolution of QoL after the ablation
Time Frame
Months 3 and 12 post-ablation
Title
Stroke including TIA after 3, 12, 24 and 36 months
Time Frame
Months 3, 12, 24 and 36 post-ablation
Title
Death cardiovascular or non-cardiovascular after 3, 12, 24 and 36 months
Time Frame
Months 3, 12, 24 and 36 post-ablation
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, expected to be on average 20-60 minutes
Title
Size (area calculate in cm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres
Time Frame
During redo-procedure, expected to be on average 20-60 minutes
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 ECG or Holter monitor (lasting ≥30 seconds) within the last 24 months. According to current guidelines, paroxysmal is defined as any 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 Vitamin-K-Antagonists or a novel oral anticoagulant for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or computer tomography 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
Exclusion Criteria:
Previous left atrial (LA) ablation or LA surgery
AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
Intracardiac thrombus
Pre-existing pulmonary vein stenosis or PV stent
Pre-existing hemidiaphragmatic paralysis
Contraindication to anticoagulation or radiocontrast materials
Prior mitral valve surgery
Severe mitral regurgitation or moderate/severe mitral stenosis
Myocardial infarction during the 3-month period preceding the consent date
Ongoing triple therapy
Cardiac surgery during the three-month interval preceding the consent date or scheduled cardiac surgery/TAVI procedure
Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
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; eGFR <30 ml/min)
Uncontrolled hyperthyroidism
Cerebral ischemic event (stroke or TIA) during the six-month interval preceding the consent date
Ongoing systemic infections
History of cryoglobulinemia
Cardiac amyloidosis
Pregnancy
Life expectancy less than one (1) year per physician opinion
Currently participating in any other clinical trial, which may confound the results of this trial.
Unwilling or unable to comply fully with study procedures and follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Reichlin, MD
Phone
+41 31 664 00 50
Email
Tobias.Reichlin@insel.ch
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrisitan Sticherling, MD
Phone
+41 61 265 52 14
Email
Christian.Sticherling@usb.ch
Facility Name
Inselspital, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Reichlin, MD
Phone
+41 31 664 00 50
Email
Tobias.Reichlin@insel.ch
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients With Symptomatic Paroxysmal Atrial Fibrillation
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