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Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation (FROZEN-AF)

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ClinicalTrials.gov Identifier: NCT04133168
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE October 3, 2019
First Posted Date  ICMJE October 21, 2019
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE June 24, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2019)
  • Rate of Primary Safety Events at 12 Months post-procedure (acute and chronic events) [ Time Frame: 12 Months ]
    composite of procedure-related and device-related adverse events. 7 days (Death, Myocardial infarction, Transient ischemic attack, Stroke/ Cerebrovascular accident, Vascular access complications, Mitral or tricuspid valvular damage, Thromboembolism/ Air embolism leading to a life-threatening event such as a ventricular arrhythmia, stroke, pulmonary embolism, or myocardial infarction and, thromboembolic events that result in permanent injury, require intervention for treatment or prolongs or require hospitalization for more than 48 hours, Gastroparesis/injury to vagus nerve, Pneumothorax, Pulmonary edema/heart failure AV block); 30 days (Cardiac tamponade/perforation); 12 months: (Atrial esophageal fistula, Severe Pulmonary vein stenosis, Persistent phrenic nerve palsy .
  • Freedom from Treatment Failure at 12 Months post-procedure. [ Time Frame: 12 Months ]
    freedom from the composite of: 1)Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period; 2 Use of amiodarone post index procedure; 3 Surgical treatment for AF/AFL/AT post index procedure; 4) Use of a non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period; 5) More than one repeat procedure with the POLARx catheter during the blanking period (90 days post index procedure); 6) Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event between days 91 and 365 days post index procedure; 7) Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between days 91 post index procedure and 365 days:Repeat procedure - Electrical and/or pharmacological cardioversion for AF/AFL/AT - Prescribed any antiarrhythmic drug (AAD)*
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Primary Safety Event Free Rate at 12 Months post-procedure (acute and chronic events) [ Time Frame: 12 Months ]
    composite of procedure-related and device-related adverse events. 7 days (Death, Myocardial infarction, Transient ischemic attack, Stroke/ Cerebrovascular accident, Vascular access complications, Mitral or tricuspid valvular damage, Thromboembolism/ Air embolism leading to a life-threatening event such as a ventricular arrhythmia, stroke, pulmonary embolism, or myocardial infarction and, thromboembolic events that result in permanent injury, require intervention for treatment or prolongs or require hospitalization for more than 48 hours, Gastroparesis/injury to vagus nerve, Pneumothorax, Pulmonary edema/heart failure AV block); 30 days (Cardiac tamponade/perforation); 12 months: (Atrial esophageal fistula, Severe Pulmonary vein stenosis, Persistent phrenic nerve palsy .
  • Failure-free rate at 12 Months post-procedure. [ Time Frame: 12 Months ]
    freedom from the composite of: 1)Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period; 2 Use of amiodarone post index procedure; 3 Surgical treatment for AF/AFL/AT post index procedure; 4) Use of a non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period; 5) More than one repeat procedure with the POLARx catheter during the blanking period (90 days post index procedure); 6) Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event between days 91 and 365 days post index procedure; 7) Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between days 91 post index procedure and 365 days:Repeat procedure - Electrical and/or pharmacological cardioversion for AF/AFL/AT - Prescribed any antiarrhythmic drug (AAD)*
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2019)
  • Rate of Acute Procedural Success defined as the achievement of electrical isolation of all PVs by using the Cardiac Cryoablation system [ Time Frame: 1 day ]
    the achievement of electrical isolation of all PVs by using the POLARx Cardiac Cryoablation system only. Electrical isolation of a PV is demonstrated by entrance and exit block.
  • Rate of reportable Adverse Events at 12 months [ Time Frame: 12 months ]
    • All Serious Adverse Events
    • All Study Procedure-Related Adverse Events
    • All Study Device-Related Adverse Events
    • All Study Device Deficiencies
    • Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in Investigator's Brochure or DFU
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Acute Procedural Success [ Time Frame: 1 day ]
    the achievement of electrical isolation of all PVs by using the POLARx Cardiac Cryoablation system only. Electrical isolation of a PV is demonstrated by entrance and exit block.
  • Reportable Adverse Events [ Time Frame: 12 months ]
    • All Serious Adverse Events
    • All Study Procedure-Related Adverse Events
    • All Study Device-Related Adverse Events
    • All Study Device Deficiencies
    • Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in Investigator's Brochure or DFU
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Official Title  ICMJE Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Brief Summary To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
Detailed Description Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific's Cryoablation System. The Cryoablation System is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for twelve (12) months after the index procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open label, prospective, single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE Device: POLARx™ Cardiac Cryoablation System

The POLARx Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The system consists of the following devices and components:

  • POLARx™ Cryoablation Catheter
  • POLARMAP™ Catheter
  • POLARSHEATH™
  • SMARTFREEZE™ Console
  • Diaphragm Movement Sensor (DMS)
  • Related Accessories
Study Arms  ICMJE Experimental: Cryoablation
Subjects undergoing cardiac ablation procedure with the POLARx™ Cardiac Cryoablation System
Intervention: Device: POLARx™ Cardiac Cryoablation System
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2019)
405
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of recurrent symptomatic paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following:

    • a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes within six months prior to enrollment, and one electrocardiographically documented AF episode within 12 months prior to enrollment.
  • No amiodarone use within 90 days prior to enrollment;
  • Subjects who are indicated for an ablation procedure for paroxysmal atrial fibrillation (PAF) according to 2017 HRS expert consensus statement on catheter and surgical ablation of atrial fibrillation;
  • Subjects refractory or intolerant to at least one class I or III antiarrhythmic medication;
  • Subjects who are willing and capable of providing informed consent;
  • Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
  • Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  • Any known contraindication to an AF ablation or anticoagulation;
  • Continuous AF lasting longer than seven (7) days from onset;
  • History of previous left atrial ablation or surgical treatment for AF/ AFL/ AT;
  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
  • Structural heart disease or implanted devices as described below:

    1. Left ventricular ejection fraction (LVEF) < 40% based on the most recent transthoracic echocardiogram (TTE) (≤180 days prior to enrollment);
    2. Left atrial diameter > 55 mm OR left atrial volume > 50 ml/m2 ml indexed based on the most recent TTE (≤ 180 days prior to enrollment);
    3. An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder;
    4. Previous cardiac surgery: i.e. ventriculotomy or atriotomy (excluding atriotomy for CABG);
    5. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips;
    6. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occlude;
    7. Presence of a left atrial appendage occlusion device;
    8. Presence of any pulmonary vein stents;
    9. Coronary artery bypass graft (CABG), PTCA/ PCI/ coronary stent procedures within 90 days prior to enrollment;
    10. Unstable angina or ongoing myocardial ischemia;
    11. myocardial infarction within 90 days prior to enrollment;
    12. Moderate or severe mitral insufficiency assessed on the most recent TTE (≤180 days prior to enrollment, e.g. pulmonary artery pressure >30 mmHg);
    13. Evidence of left atrial thrombus;
  • Any previous history of cryoglobulinemia;
  • Stage 3B or higher renal disease (estimated glomerular filtration rate, eGFR <45 mL/min);
  • History of blood clotting or bleeding disease;
  • Any prior history of documented cerebral infarct, TIA or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] ≤180 days prior to enrollment;
  • Active systemic infection;
  • Pregnant, lactating (current or anticipated during study follow up), or women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
  • Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility;
  • Subjects who in the judgment of the investigator have a life expectancy of less than two years.
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: Allison Anderson +1 919-345-6001 allison.anderson@bsci.com
Contact: Giovanni Raciti +39 348 2502687 giovanni.raciti@bsci.com
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Hong Kong,   Italy,   Netherlands,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04133168
Other Study ID Numbers  ICMJE PY004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kenneth Ellenbogen, MD VCU Pauley Heart Center, Richmond, Virginia, USA
Principal Investigator: Arash Aryana, MD, PhD Mercy General Hospital,Sacramento, CA , USA
Principal Investigator: Nassir Marrouche, MD University of Utah School of Medicine. Slat Lake City, UT, USA
Principal Investigator: Ante Anić, MD University Hospital, Split, Croatia
Principal Investigator: Suneet Mittal, MD, FACC, FHRS Snyder AF Center, New York, NY, USA
Principal Investigator: Niraj Varma, MD, PhD, FRCP Cleveland Clinic, Cleveland OH, USA
Principal Investigator: Wilber W Su, MD, FACC, FHRS Banner- University Medical Group- Heart Center, Phoenix, AZ, USA
PRS Account Boston Scientific Corporation
Verification Date June 2021

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