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To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Experimental | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Cardiac Cryoablation System | Device | The Boston Scientific 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 main devices and components of the system consists of the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models | This measure reports the observed safety event-free rate at 12 Months follow up for all Non Roll-In treatment and intent subjects. The safety events are a 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 . | 12 Months |
| Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models | Freedom from the composite of: Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period; Use of amiodarone post index procedure; Surgical treatment for AF/AFL/AT post index procedure; Use of non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period; More than one repeat procedure with the POLARx catheter during the blanking period (90 days post index procedure); Documented AF, or new onset of AF or AT event 91-365 days post index procedure; Any of the following for AF, or new onset of AF or AT 91-365 days post index procedure: Repeat procedure - Electrical and/or pharmacological cardioversion for AF/AFL/AT - Prescribed AAD consisting of any Class I/III, including Amiodarone, and any Class II/IV medications taken for control of AF, AT, AFL recurrence | 12 Months |
| Percentage of Participants With Freedom From Primary Safety Events at 3 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Acute Procedural Success Defined as the Achievement of Electrical Isolation of All PVs by Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter | The achievement of electrical isolation of all PVs by using the POLARx Cardiac Cryoablation System. Electrical isolation of a PV is demonstrated by entrance and exit block. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Recurrence | The following analysis looks at the recurrence free rate of individual atrial arrhythmia types as documented on a rhythm monitoring device post- blanking period. | 12 Months |
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Ellenbogen, MD | VCU Pauley Heart Center, Richmond, Virginia, USA | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Pima Heart and Vascular |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38448797 | Result | Ellenbogen KA, Mittal S, Varma N, Aryana A, Marrouche N, Anic A, Nair D, Champagne J, Iacopino S, de Asmundis C, Weiner S, Makati K, Raybuck JD, Richards E, Su W. One-year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial. J Cardiovasc Electrophysiol. 2024 Apr;35(4):832-842. doi: 10.1111/jce.16220. Epub 2024 Mar 6. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | FROzEN | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific 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 main devices and components of the system consists of the following:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| FROzEN AF Clinical Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2022 |
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open label, prospective, single arm study
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|
Composite of procedure-related and device-related adverse events. 7 days post index procedure or hospital discharge, whichever is later, unless denoted as events counting through 3 months post index procedure (Death, Myocardial infarction, Major Vagal Nerve Injury/Gastroparesis, Transient ischemic attack, Stroke/Cerebrovascular accident, Thromboembolism, Cardiac tamponade/perforation, Pneumothorax, Major vascular access complications, Pulmonary edema/heart failure, AV block, Atrial esophageal fistula, severe pulmonary vein stenosis (≥70% reduction in the diameter of the PV or PV branch from baseline), Persistent phrenic nerve palsy) |
| 3 months |
| Percentage of Participants With Acute Procedural Success Defined as the Achievement of Electrical Isolation of All PVs by Using the Boston Scientific Cardiac Cryoablation System With POLARx Fit Cryoablation Balloon Catheter Models | The primary effectiveness endpoint is the rate of acute procedural success where acute procedural success is defined as the achievement of electrical isolation of all PVs by using the Cardiac Cryoablation System with the POLARx FIT cryoablation balloon catheter models (with treatment applied at 28 mm or 31 mm balloon size per physician discretion). Electrical isolation of a PV is demonstrated by entrance and exit block. | 1 day |
| Number of Participants With Freedom From Reportable Adverse Events at 12 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models |
| 12 months |
| Percentage of Participants With Freedom From Safety Events at 12 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models | The following events will be counted through 7 days post index procedure or hospital discharge, whichever is later: Death, Myocardial infarction, Major Vagal Nerve Injury/Gastroparesis, Transient ischemic attack, Stroke/Cerebrovascular accident, Thromboembolism, Pneumothorax, Major vascular access complications, Pulmonary edema/heart failure, AV block. The following event will be counted through 30 days post index procedure: Cardiac tamponade/perforation. The following events will be counted through 12 months post index procedure: Atrial esophageal fistula, Severe pulmonary vein stenosis (≥70% reduction in the diameter of the PV or PV branch from baseline), Persistent phrenic nerve palsy. | 12 Months |
| Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models | Freedom from the composite of: Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period; Use of amiodarone post index procedure; Surgical treatment for AF/AFL/AT post index procedure; Use of non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period; More than one repeat procedure with the Cryoablation System during the blanking period (90 days post index procedure); Documented AF, or new onset of AF or AT event 91-365 days post index procedure; Any of the following for AF, or new onset of AF or AT 91-365 days post index procedure: Repeat procedure - Electrical and/or pharmacological cardioversion for AF/AFL/AT - Prescribed AAD consisting of any Class I/III, including Amiodarone, and any Class II/IV medications taken for control of AF, AT, AFL recurrence | 12 Months |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | United States |
| Cedars - Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Torrance Memorial Medical Center | Torrance | California | 90505 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| St. Joseph's Hospital | Tampa | Florida | 33614 | United States |
| Emory University Hospital | Atlanta | Georgia | 30308 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Southcoast Physicians Group | Fall River | Massachusetts | 02720 | United States |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Valley Hospital | Ridgewood | New Jersey | 07450-2736 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Northwell Health | Staten Island | New York | 10305 | United States |
| St. Joseph's Hospital Health Center | Syracuse | New York | 13203 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Stern Cardiovascular Foundation, Inc. | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | United States |
| Christus Trinity Mother Frances Health System | Tyler | Texas | 75702 | United States |
| Chippenham & Johnston-Willis Hospital | Richmond | Virginia | 23225 | United States |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | United States |
| PeaceHealth Southwest Medical | Vancouver | Washington | 98664 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| Aurora Health Care | Grafton | Wisconsin | 53024 | United States |
| UZ Brussels | Brussels | Belgium |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| Institut de Cardiologie de Montreal | Montreal | Canada |
| Institut universitaire de Cardiologie et de Pneumologie de Quebec | Québec | G1V 4G5 | Canada |
| Vancouver General Hospital | Vancouver | Canada |
| CHU Grenoble - Hopital Michallon | Grenoble | 38043 | France |
| Herz-und Diabeteszentrum Nordrhein-Westfalen | Bad Oeynhausen | Germany |
| Universitaetsklinikum Schleswig-Holstein | Lübeck | D-23538 | Germany |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Prince of Wales Hospital | Shatin | Hong Kong |
| Maria Cecilia Hospital SPA | Cotignola | Italy |
| Erasmus MC- University Medical Center Rotterdam | Rotterdam | 3015 CE | Netherlands |
| Taipei Veterans General Hospital | Taipei | Beitou District | 11217 | Taiwan |
| National Taiwan University Hospital | Taipei | Zhongzheng Dist | 10002 | Taiwan |
| Procedure |
|
| Pre-Discharge |
|
| 7 Day Follow Up |
|
| 3 Month Follow Up |
|
| 6 Month Follow Up |
|
| 12 Month Follow Up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| POLARx FIT Substudy |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FROzEN Non Roll-In Treatment Subjects | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific 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 main devices and components of the system consists of the following:
|
| BG001 | POLARx FIT Sub-study | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific 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 main devices and components of the system consists of the following:
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Pulse | Mean | Standard Deviation | bpm |
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| Systolic BP | Mean | Standard Deviation | mmHg |
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| Diastolic BP | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| CHA2DS2-VASc Score | The CHA2DS2-VASc Score is a medical scale that refers to the various factors influencing the risk of stroke and other vascular incidents in patients with atrial fibrillations. A higher score indicates a higher risk. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models | This measure reports the observed safety event-free rate at 12 Months follow up for all Non Roll-In treatment and intent subjects. The safety events are a 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 . | Non Roll-In Treatment and intent Subjects | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Months |
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| Primary | Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models | Freedom from the composite of: Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period; Use of amiodarone post index procedure; Surgical treatment for AF/AFL/AT post index procedure; Use of non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period; More than one repeat procedure with the POLARx catheter during the blanking period (90 days post index procedure); Documented AF, or new onset of AF or AT event 91-365 days post index procedure; Any of the following for AF, or new onset of AF or AT 91-365 days post index procedure: Repeat procedure - Electrical and/or pharmacological cardioversion for AF/AFL/AT - Prescribed AAD consisting of any Class I/III, including Amiodarone, and any Class II/IV medications taken for control of AF, AT, AFL recurrence | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Months |
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| Primary | Percentage of Participants With Freedom From Primary Safety Events at 3 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models | Composite of procedure-related and device-related adverse events. 7 days post index procedure or hospital discharge, whichever is later, unless denoted as events counting through 3 months post index procedure (Death, Myocardial infarction, Major Vagal Nerve Injury/Gastroparesis, Transient ischemic attack, Stroke/Cerebrovascular accident, Thromboembolism, Cardiac tamponade/perforation, Pneumothorax, Major vascular access complications, Pulmonary edema/heart failure, AV block, Atrial esophageal fistula, severe pulmonary vein stenosis (≥70% reduction in the diameter of the PV or PV branch from baseline), Persistent phrenic nerve palsy) | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 months |
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| Primary | Percentage of Participants With Acute Procedural Success Defined as the Achievement of Electrical Isolation of All PVs by Using the Boston Scientific Cardiac Cryoablation System With POLARx Fit Cryoablation Balloon Catheter Models | The primary effectiveness endpoint is the rate of acute procedural success where acute procedural success is defined as the achievement of electrical isolation of all PVs by using the Cardiac Cryoablation System with the POLARx FIT cryoablation balloon catheter models (with treatment applied at 28 mm or 31 mm balloon size per physician discretion). Electrical isolation of a PV is demonstrated by entrance and exit block. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 day |
|
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| Secondary | Percentage of Participants With Acute Procedural Success Defined as the Achievement of Electrical Isolation of All PVs by Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter | The achievement of electrical isolation of all PVs by using the POLARx Cardiac Cryoablation System. Electrical isolation of a PV is demonstrated by entrance and exit block. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 day |
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| Secondary | Number of Participants With Freedom From Reportable Adverse Events at 12 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models |
| The total population represents all Non-Roll In (336) and Roll in (63) enrolled subjects. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Percentage of Participants With Freedom From Safety Events at 12 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models | The following events will be counted through 7 days post index procedure or hospital discharge, whichever is later: Death, Myocardial infarction, Major Vagal Nerve Injury/Gastroparesis, Transient ischemic attack, Stroke/Cerebrovascular accident, Thromboembolism, Pneumothorax, Major vascular access complications, Pulmonary edema/heart failure, AV block. The following event will be counted through 30 days post index procedure: Cardiac tamponade/perforation. The following events will be counted through 12 months post index procedure: Atrial esophageal fistula, Severe pulmonary vein stenosis (≥70% reduction in the diameter of the PV or PV branch from baseline), Persistent phrenic nerve palsy. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Months |
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| Secondary | Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models | Freedom from the composite of: Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period; Use of amiodarone post index procedure; Surgical treatment for AF/AFL/AT post index procedure; Use of non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period; More than one repeat procedure with the Cryoablation System during the blanking period (90 days post index procedure); Documented AF, or new onset of AF or AT event 91-365 days post index procedure; Any of the following for AF, or new onset of AF or AT 91-365 days post index procedure: Repeat procedure - Electrical and/or pharmacological cardioversion for AF/AFL/AT - Prescribed AAD consisting of any Class I/III, including Amiodarone, and any Class II/IV medications taken for control of AF, AT, AFL recurrence | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Months |
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| Other Pre-specified | Percentage of Participants With Freedom From Recurrence | The following analysis looks at the recurrence free rate of individual atrial arrhythmia types as documented on a rhythm monitoring device post- blanking period. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Months |
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| Post-Hoc | Percentage of Participants With Freedom From Treatment Failure With Updated AAD Definition at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models | In this sensitivity analysis, subjects were counted as primary effectiveness failures only if they were taking a new AAD not prescribed prior to index procedure or a higher dose of an AAD than they were previously prescribed. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Months |
|
|
Through 12 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FROzEN Non Roll In Treatment and Attempt Subjects | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific 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 main devices and components of the system consists of the following:
| 1 | 336 | 33 | 326 | 86 | 326 |
| EG001 | FROzEN Roll In Treatment Subjects | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific 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 main devices and components of the system consists of the following:
| 1 | 60 | 10 | 60 | 16 | 60 |
| EG002 | POLARx FIT Treatment Subjects | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific 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 main devices and components of the system consists of the following:
| 0 | 50 | 4 | 50 | 5 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina/ chest pain | Surgical and medical procedures | Systematic Assessment |
| ||
| Edema | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain-other | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| ||
| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Fever and/or virus | General disorders | Systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Integumentary | General disorders | Systematic Assessment |
| ||
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Atrial Tachycardia/ Other SVT (e.g. AVRT, AVNRT, EAT) | Cardiac disorders | Systematic Assessment |
| ||
| Multiple Symptoms | General disorders | Systematic Assessment |
| ||
| Peripheral vascular disease | Cardiac disorders | Systematic Assessment |
| ||
| Abnormal lab values | General disorders | Systematic Assessment |
| ||
| Cancer | General disorders | Systematic Assessment |
| ||
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Physical Trauma | General disorders | Systematic Assessment |
| ||
| Pulmonary | General disorders | Systematic Assessment |
| ||
| 1st Degree AV block | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atypical (Type II) Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Hypertensive/ Hypertensive crisis | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Tachycardiac (VT)/ Monomorphic VT | Cardiac disorders | Systematic Assessment |
| ||
| COPD Exacerbation | General disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Genitourinary | Renal and urinary disorders | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Vasovagal Reaction | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedure related Pulmonary (including cough, hemoptysis) | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial (Type I) Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain- other | Cardiac disorders | Systematic Assessment |
| ||
| Conduction pathway injury | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| ||
| Dizziness | Cardiac disorders | Systematic Assessment |
| ||
| Hypertension/ Hypertensive crisis | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension/ Orthostatic hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Multiple symptoms | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia (VT)/ Monomorphic VT | Cardiac disorders | Systematic Assessment |
| ||
| Fever and/or virus | General disorders | Systematic Assessment |
| ||
| Head, Eyes, Ears, Nose, Throat (HEENT) | General disorders | Systematic Assessment |
| ||
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Physical Trauma | General disorders | Systematic Assessment |
| ||
| Pulmonary | General disorders | Systematic Assessment |
| ||
| Renal | Renal and urinary disorders | Systematic Assessment |
| ||
| Procedure related Anesthesia/ sedation | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial tachycardia/ Other SVT (e.g AVRT, AVNRT, EAT) | Cardiac disorders | Systematic Assessment |
| ||
| Localized infection | Infections and infestations | Systematic Assessment |
| ||
| Psychological | General disorders | Systematic Assessment |
| ||
| Premature atrial contractions (PAC) | Cardiac disorders | Systematic Assessment |
| ||
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ablation induced Arrhythmia | Surgical and medical procedures | Systematic Assessment |
| ||
| Angina/ chest pain | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial Flutter (not specified) | Surgical and medical procedures | Systematic Assessment |
| ||
| Bleeding related to anticogulation | Surgical and medical procedures | Systematic Assessment |
| ||
| Edema | Surgical and medical procedures | Systematic Assessment |
| ||
| Embolism - air | Surgical and medical procedures | Systematic Assessment |
| ||
| Esophagitis | Surgical and medical procedures | Systematic Assessment |
| ||
| Gasteroparesis | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| Myocardial Infarction | Surgical and medical procedures | Systematic Assessment |
| ||
| Myocardial Perforation with tamponade | Surgical and medical procedures | Systematic Assessment |
| ||
| Oozing/ bleeding | Surgical and medical procedures | Systematic Assessment |
| ||
| Pain (non-cardiovascular) | Surgical and medical procedures | Systematic Assessment |
| ||
| Pericarditis | Surgical and medical procedures | Systematic Assessment |
| ||
| Phrenic Nerve Injury temporary | Surgical and medical procedures | Systematic Assessment |
| ||
| Pleuritis | Surgical and medical procedures | Systematic Assessment |
| ||
| Post procedure infection/ Sepsis | Surgical and medical procedures | Systematic Assessment |
| ||
| Post procedure wound discomfort | Surgical and medical procedures | Systematic Assessment |
| ||
| Procedure related allergic reactions/ adverse drug reaction | Surgical and medical procedures | Systematic Assessment |
| ||
| Procedure related anesthesia/ sedation | Surgical and medical procedures | Systematic Assessment |
| ||
| Procedure related gastrointestinal | Surgical and medical procedures | Systematic Assessment |
| ||
| Procedure related hypertension | Surgical and medical procedures | Systematic Assessment |
| ||
| Procedure related Neurological (non-TIA, non-stroke, dysphagia, speech disturbance/ dysarthria) | Surgical and medical procedures | Systematic Assessment |
| ||
| Pulmonary Edema | Surgical and medical procedures | Systematic Assessment |
| ||
| Right atrial (type 1) atrial flutter | Surgical and medical procedures | Systematic Assessment |
| ||
| Dyspnea | Cardiac disorders | Systematic Assessment |
|
Institution and Investigator shall have the right to publish the Results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. In addition, Sponsor may extend such review period for another ninety (90) days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Roelke, Clinical Trial Manager | Boston Scientific | 651-582-4000 | Stephanie.Roelke@bsci.com |
| Oct 4, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
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| Native American |
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| Asian |
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| Black |
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| Pacific Islander |
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| White |
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| Other |
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| Race Undisclosed |
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| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| Participants |
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