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出境医 / 临床实验 / Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation (Cryo-InitialAF)

Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation (Cryo-InitialAF)

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation, Persistent Arrhythmias, Cardiac Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone Device: cryoballoon ablation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2023
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Drug treatment group
receive class I or class III AAD to restore or maintain sinus rhythm.
 Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
Class I or III antiarrhythmic drug, including sotalol
Experimental: cryoballoon ablation group
receive cryoballoon ablation to restore sinus rhythm.
 Device: cryoballoon ablation
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
Outcome Measures
Primary Outcome Measures :
  1. Treatment success at 12 months [ Time Frame: Randomization to 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.

  2. Rate of serious adverse events [ Time Frame: Randomization to 12 months ]
    Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure


Secondary Outcome Measures :
  1. Quality of life changes at 12 months measured by AFEQT [ Time Frame: one year ]
    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)

  2. Quality of life changes at 12 months measured by SF-12 [ Time Frame: one year ]
    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)

  3. Arrhythmia recurrence during blanking period [ Time Frame: 3 months ]
    atrial tachycardia recurrence rate during the blanking period

  4. time to first time cardiovascular hospitalization (month) [ Time Frame: one year ]
    time to first time cardiovascular hospitalization after treatment (month)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Li-qun Wu, MD,PhD +8613801621534 wuliqun89@hotmail.com
Contact: Yangyang Bao, MD,PhD +8613301687572 575525677@qq.com

Locations
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China
Ruijin Hospital
Shanghai, China, 200025
Contact: Li-qun Wu, MD,PhD    +8613801621534    wuliqun89@hotmail.com   
Contact: Yangyang Bao, MD,PhD    +8613301687572    575525677@qq.com   
Principal Investigator: Li-qun Wu, MD,PhD         
Sub-Investigator: Yangyang Bao, MD,PhD         
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Li-qun Wu, MD,PhD Ruijin Hospital
Tracking Information
First Submitted Date  ICMJE June 17, 2021
First Posted Date  ICMJE June 29, 2021
Last Update Posted Date July 29, 2021
Estimated Study Start Date  ICMJE August 2021
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2021)
  • Treatment success at 12 months [ Time Frame: Randomization to 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 [ Time Frame: Randomization to 12 months ]
    Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2021)
  • Quality of life changes at 12 months measured by AFEQT [ Time Frame: one year ]
    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 [ Time Frame: one year ]
    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 [ Time Frame: 3 months ]
    atrial tachycardia recurrence rate during the blanking period
  • time to first time cardiovascular hospitalization (month) [ Time Frame: one year ]
    time to first time cardiovascular hospitalization after treatment (month)
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 Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
Official Title  ICMJE Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation, Persistent
  • Arrhythmias, Cardiac
Intervention  ICMJE
  • Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
    Class I or III antiarrhythmic drug, including sotalol
  • Device: cryoballoon ablation
    Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
Study Arms  ICMJE
  • Active Comparator: Drug treatment group
    receive class I or class III AAD to restore or maintain sinus rhythm.
    Intervention: Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
  • Experimental: cryoballoon ablation group
    receive cryoballoon ablation to restore sinus rhythm.
    Intervention: Device: cryoballoon ablation
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2021) 		286
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Li-qun Wu, MD,PhD +8613801621534 wuliqun89@hotmail.com
Contact: Yangyang Bao, MD,PhD +8613301687572 575525677@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04942834
Other Study ID Numbers  ICMJE Cryo-initial-AF
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: No
Responsible Party Ruijin Hospital
Study Sponsor  ICMJE Ruijin Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li-qun Wu, MD,PhD Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date June 2021

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