Back to resultsUsing Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation (Cryo-InitialAF)
Primary Purpose
Atrial Fibrillation, Persistent, Arrhythmias, Cardiac
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
cryoballoon ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation, Persistent focused on measuring cryoablation, pulmonary vein isolation, atrial fibrillation, Anti-Arrhythmic Agents
Eligibility Criteria
Inclusion Criteria:
- Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
- Age 18 or older (or older than 18 if required by local law)
- Structurally normal heart with LVEF ≥50%, interventricular septum thickness ≤ 12 mm, and left atrial diameter <46 mm (short axis) as obtained by transthoracic echocardiography. •
- Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms in a 12-channel surface ECG, QTc interval <440 ms, and PQ interval ≤210 ms).
Exclusion Criteria:
- History of AF treatment with class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
- left atrial ablation or surgical procedure (including left atrial appendage closures)
- Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Presence of any cardiac valve prosthesis
- +3 and +4 mitral valve regurgitation or stenosis
- Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding e consent date
- Unstable angina
- New York Heart Association (NYHA) Class II, III or IV congestive heart failure
- Primary pulmonary hypertension
- Rheumatic heart disease
- Thrombocytosis, thrombocytopenia
- Any condition contraindicating chronic anticoagulation
- Active systemic infection
- Hypertrophic cardiomyopathy
- Cryoglobulinemia
- Uncontrolled hyperthyroidism
- Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
- Any woman known to be pregnant or breastfeeding.
- Life expectancy less than one year
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- Active intracardiac thrombus
- Known drug or alcohol dependency
- Unwilling or unable to comply fully with study procedures and follow-up
- Significant Chronic Kidney Disease-estimated Glomerular Filtration Rate(CKD-eGFR) <30umol/L
Sites / Locations
- Ruijin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Drug treatment group
cryoballoon ablation group
Arm Description
receive class I or class III AAD to restore or maintain sinus rhythm.
receive cryoballoon ablation to restore sinus rhythm.
Outcomes
Primary Outcome Measures
Treatment success at 12 months
Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.
Rate of serious adverse events
Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure
Secondary Outcome Measures
Quality of life changes at 12 months measured by AFEQT
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT)
Quality of life changes at 12 months measured by SF-12
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12)
Arrhythmia recurrence during blanking period
atrial tachycardia recurrence rate during the blanking period
time to first time cardiovascular hospitalization (month)
time to first time cardiovascular hospitalization after treatment (month)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04942834
Brief Title
Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
Acronym
Cryo-InitialAF
Official Title
Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
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
This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.
Detailed Description
Subjects with persistent atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent, Arrhythmias, Cardiac
Keywords
cryoablation, pulmonary vein isolation, atrial fibrillation, Anti-Arrhythmic Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug treatment group
Arm Type
Active Comparator
Arm Description
receive class I or class III AAD to restore or maintain sinus rhythm.
Arm Title
cryoballoon ablation group
Arm Type
Experimental
Arm Description
receive cryoballoon ablation to restore sinus rhythm.
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
Intervention Description
Class I or III antiarrhythmic drug, including sotalol
Intervention Type
Device
Intervention Name(s)
cryoballoon ablation
Intervention Description
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
Primary Outcome Measure Information:
Title
Treatment success at 12 months
Description
Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.
Time Frame
Randomization to 12 months
Title
Rate of serious adverse events
Description
Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure
Time Frame
Randomization to 12 months
Secondary Outcome Measure Information:
Title
Quality of life changes at 12 months measured by AFEQT
Description
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT)
Time Frame
one year
Title
Quality of life changes at 12 months measured by SF-12
Description
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12)
Time Frame
one year
Title
Arrhythmia recurrence during blanking period
Description
atrial tachycardia recurrence rate during the blanking period
Time Frame
3 months
Title
time to first time cardiovascular hospitalization (month)
Description
time to first time cardiovascular hospitalization after treatment (month)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
Age 18 or older (or older than 18 if required by local law)
Structurally normal heart with LVEF ≥50%, interventricular septum thickness ≤ 12 mm, and left atrial diameter <46 mm (short axis) as obtained by transthoracic echocardiography. •
Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms in a 12-channel surface ECG, QTc interval <440 ms, and PQ interval ≤210 ms).
Exclusion Criteria:
History of AF treatment with class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
left atrial ablation or surgical procedure (including left atrial appendage closures)
Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
Presence of any pulmonary vein stents
Presence of any pre-existing pulmonary vein stenosis
Pre-existing hemidiaphragmatic paralysis
Presence of any cardiac valve prosthesis
+3 and +4 mitral valve regurgitation or stenosis
Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding e consent date
Unstable angina
New York Heart Association (NYHA) Class II, III or IV congestive heart failure
Primary pulmonary hypertension
Rheumatic heart disease
Thrombocytosis, thrombocytopenia
Any condition contraindicating chronic anticoagulation
Active systemic infection
Hypertrophic cardiomyopathy
Cryoglobulinemia
Uncontrolled hyperthyroidism
Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
Any woman known to be pregnant or breastfeeding.
Life expectancy less than one year
Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
Active intracardiac thrombus
Known drug or alcohol dependency
Unwilling or unable to comply fully with study procedures and follow-up
Significant Chronic Kidney Disease-estimated Glomerular Filtration Rate(CKD-eGFR) <30umol/L
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-qun Wu, MD,PhD
Phone
+8613801621534
Email
wuliqun89@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yangyang Bao, MD,PhD
Phone
+8613301687572
Email
575525677@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-qun Wu, MD,PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-qun Wu, MD,PhD
Phone
+8613801621534
Email
wuliqun89@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yangyang Bao, MD,PhD
Phone
+8613301687572
Email
575525677@qq.com
First Name & Middle Initial & Last Name & Degree
Li-qun Wu, MD,PhD
First Name & Middle Initial & Last Name & Degree
Yangyang Bao, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
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