Trial Outcomes & Findings for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation (NCT NCT04133168)

Last Updated: 2025-04-03

Results Overview

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 .

Recruitment status

COMPLETED

Study phase

Target enrollment

458 participants

Primary outcome timeframe

12 Months

Results posted on

2025-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
FROzEN AF Clinical Study STARTED	404
FROzEN AF Clinical Study Procedure	326
FROzEN AF Clinical Study Pre-Discharge	325
FROzEN AF Clinical Study 7 Day Follow Up	321
FROzEN AF Clinical Study 3 Month Follow Up	315
FROzEN AF Clinical Study 6 Month Follow Up	310
FROzEN AF Clinical Study 12 Month Follow Up	308
FROzEN AF Clinical Study COMPLETED	308
FROzEN AF Clinical Study NOT COMPLETED	96
POLARx FIT Substudy STARTED	54
POLARx FIT Substudy Pre-Discharge	50
POLARx FIT Substudy 3 Month Follow Up	50
POLARx FIT Substudy 6 Month Follow Up	50
POLARx FIT Substudy 12 Month Follow Up	49
POLARx FIT Substudy COMPLETED	49
POLARx FIT Substudy NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FROzEN Non Roll-In Treatment Subjects n=325 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories	POLARx FIT Sub-study n=50 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories	Total n=375 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 11 • n=5 Participants	64 years STANDARD_DEVIATION 13 • n=7 Participants	62 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	23 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	201 Participants n=5 Participants	27 Participants n=7 Participants	228 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	35 Participants n=5 Participants	0 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	274 Participants n=5 Participants	49 Participants n=7 Participants	323 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race Undisclosed	12 Participants n=5 Participants	0 Participants n=7 Participants	12 Participants n=5 Participants
Height	174 cm STANDARD_DEVIATION 10 • n=5 Participants	173 cm STANDARD_DEVIATION 10 • n=7 Participants	174 cm STANDARD_DEVIATION 10 • n=5 Participants
Weight	86 kg STANDARD_DEVIATION 19 • n=5 Participants	93 kg STANDARD_DEVIATION 22 • n=7 Participants	87 kg STANDARD_DEVIATION 20 • n=5 Participants
BMI	29 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	31 kg/m^2 STANDARD_DEVIATION 7 • n=7 Participants	29 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants
Pulse	67 bpm STANDARD_DEVIATION 14 • n=5 Participants	66 bpm STANDARD_DEVIATION 13 • n=7 Participants	67 bpm STANDARD_DEVIATION 14 • n=5 Participants
Systolic BP	133 mmHg STANDARD_DEVIATION 18 • n=5 Participants	134 mmHg STANDARD_DEVIATION 16 • n=7 Participants	133 mmHg STANDARD_DEVIATION 18 • n=5 Participants
Diastolic BP	79 mmHg STANDARD_DEVIATION 11 • n=5 Participants	76 mmHg STANDARD_DEVIATION 9 • n=7 Participants	79 mmHg STANDARD_DEVIATION 11 • n=5 Participants
CHA2DS2-VASc Score 0	63 Participants n=5 Participants	3 Participants n=7 Participants	66 Participants n=5 Participants
CHA2DS2-VASc Score 1	82 Participants n=5 Participants	15 Participants n=7 Participants	97 Participants n=5 Participants
CHA2DS2-VASc Score 2	92 Participants n=5 Participants	16 Participants n=7 Participants	108 Participants n=5 Participants
CHA2DS2-VASc Score 3	59 Participants n=5 Participants	5 Participants n=7 Participants	64 Participants n=5 Participants
CHA2DS2-VASc Score 4	21 Participants n=5 Participants	6 Participants n=7 Participants	27 Participants n=5 Participants
CHA2DS2-VASc Score 5	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
CHA2DS2-VASc Score 6	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Non Roll-In Treatment and intent Subjects

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=326 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	96 Percentage of participants Interval 93.8 to One sided confidence interval

PRIMARY outcome

Timeframe: 12 Months

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

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=325 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	59.9 Percentage of participants Interval 55.2 to One sided confidence interval

PRIMARY outcome

Timeframe: 3 months

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)

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=50 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	100 Percentage of participants Interval 92.9 to 100.0

PRIMARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=50 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	100 Percentage of participants Interval 92.9 to 100.0

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=325 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	95.69 Percentage of participants Interval 92.88 to 97.63

SECONDARY outcome

Timeframe: 12 months

Population: The total population represents all Non-Roll In (336) and Roll in (63) enrolled subjects.

* 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

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=399 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	254 Participants

SECONDARY outcome

Timeframe: 12 Months

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.

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=50 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	100 Percentage of participants Interval 92.9 to One sided Confidence interval

SECONDARY outcome

Timeframe: 12 Months

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

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=50 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	78 Percentage of participants Interval 66.5 to One-sided Confidence Interval

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

The following analysis looks at the recurrence free rate of individual atrial arrhythmia types as documented on a rhythm monitoring device post- blanking period.

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=325 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
Percentage of Participants With Freedom From Recurrence	79.9 Percentage of participants Interval 75.9 to One sided confidence interval

POST_HOC outcome

Timeframe: 12 Months

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.

Outcome measures

Outcome measures
Measure	FROzEN Non Roll-In Subjects n=325 Participants 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
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	71.6 Percentage of participants Interval 67.2 to One sided confidence interval

Adverse Events

FROzEN Non Roll In Treatment and Attempt Subjects

Serious events: 33 serious events

Other events: 86 other events

Deaths: 1 deaths

FROzEN Roll In Treatment Subjects

Serious events: 10 serious events

Other events: 16 other events

Deaths: 1 deaths

POLARx FIT Treatment Subjects

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FROzEN Non Roll In Treatment and Attempt Subjects n=326 participants at risk 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories	FROzEN Roll In Treatment Subjects n=60 participants at risk 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories	POLARx FIT Treatment Subjects n=50 participants at risk 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
Surgical and medical procedures Angina/ chest pain	0.00% 0/326 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Edema	0.00% 0/326 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atrial Fibrillation	1.8% 6/326 • Number of events 6 • Through 12 Months	0.00% 0/60 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
Cardiac disorders Chest pain-other	0.31% 1/326 • Number of events 2 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Coronary Artery Disease	0.00% 0/326 • Through 12 Months	0.00% 0/60 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
Cardiac disorders Sinus Bradycardia	0.92% 3/326 • Number of events 3 • Through 12 Months	0.00% 0/60 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
General disorders Fever and/or virus	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Gastrointestinal disorders Gastrointestinal	0.92% 3/326 • Number of events 5 • Through 12 Months	3.3% 2/60 • Number of events 2 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
General disorders Integumentary	0.00% 0/326 • Through 12 Months	0.00% 0/60 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
Musculoskeletal and connective tissue disorders Musculoskeletal	0.61% 2/326 • Number of events 2 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atrial Tachycardia/ Other SVT (e.g. AVRT, AVNRT, EAT)	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Multiple Symptoms	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Peripheral vascular disease	0.31% 1/326 • Number of events 1 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Abnormal lab values	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Cancer	0.31% 1/326 • Number of events 1 • Through 12 Months	3.3% 2/60 • Number of events 2 • Through 12 Months	0.00% 0/50 • Through 12 Months
Blood and lymphatic system disorders Hematological	1.2% 4/326 • Number of events 4 • Through 12 Months	3.3% 2/60 • Number of events 2 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Physical Trauma	0.31% 1/326 • Number of events 1 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Pulmonary	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 2 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders 1st Degree AV block	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atrial Flutter	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atypical (Type II) Atrial Flutter	0.31% 1/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Hypertensive/ Hypertensive crisis	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Palpitations	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Syncope	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Ventricular Tachycardiac (VT)/ Monomorphic VT	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders COPD Exacerbation	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Death	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Renal and urinary disorders Genitourinary	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Nervous system disorders Neurological	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Vasovagal Reaction	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months

Other adverse events

Other adverse events
Measure	FROzEN Non Roll In Treatment and Attempt Subjects n=326 participants at risk 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories	FROzEN Roll In Treatment Subjects n=60 participants at risk 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories	POLARx FIT Treatment Subjects n=50 participants at risk 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: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories
Surgical and medical procedures Procedure related Pulmonary (including cough, hemoptysis)	1.5% 5/326 • Number of events 5 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atrial (Type I) Flutter	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atrial Fibrillation	1.5% 5/326 • Number of events 5 • Through 12 Months	10.0% 6/60 • Number of events 6 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atrial Flutter	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Chest pain- other	0.92% 3/326 • Number of events 3 • Through 12 Months	0.00% 0/60 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
Cardiac disorders Conduction pathway injury	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Coronary Artery Disease	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Dizziness	0.31% 1/326 • Number of events 1 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
Cardiac disorders Hypertension/ Hypertensive crisis	0.31% 1/326 • Number of events 1 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Hypotension/ Orthostatic hypotension	0.92% 3/326 • Number of events 3 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Multiple symptoms	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Palpitations	0.31% 1/326 • Number of events 1 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Sinus Bradycardia	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Sinus Tachycardia	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Ventricular Tachycardia (VT)/ Monomorphic VT	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Fever and/or virus	0.31% 1/326 • Number of events 1 • Through 12 Months	3.3% 2/60 • Number of events 2 • Through 12 Months	4.0% 2/50 • Number of events 2 • Through 12 Months
General disorders Head, Eyes, Ears, Nose, Throat (HEENT)	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
Blood and lymphatic system disorders Hematological	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Nervous system disorders Neurological	0.92% 3/326 • Number of events 3 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Physical Trauma	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Pulmonary	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Renal and urinary disorders Renal	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Procedure related Anesthesia/ sedation	0.61% 2/326 • Number of events 2 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Atrial tachycardia/ Other SVT (e.g AVRT, AVNRT, EAT)	0.00% 0/326 • Through 12 Months	5.0% 3/60 • Number of events 3 • Through 12 Months	0.00% 0/50 • Through 12 Months
Infections and infestations Localized infection	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
General disorders Psychological	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Premature atrial contractions (PAC)	0.00% 0/326 • Through 12 Months	0.00% 0/60 • Through 12 Months	4.0% 2/50 • Number of events 2 • Through 12 Months
Musculoskeletal and connective tissue disorders Musculoskeletal	0.00% 0/326 • Through 12 Months	0.00% 0/60 • Through 12 Months	2.0% 1/50 • Number of events 1 • Through 12 Months
Surgical and medical procedures Ablation induced Arrhythmia	0.61% 2/326 • Number of events 2 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Angina/ chest pain	1.5% 5/326 • Number of events 5 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Atrial Flutter (not specified)	1.8% 6/326 • Number of events 6 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Bleeding related to anticogulation	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Edema	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Embolism - air	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Esophagitis	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Gasteroparesis	1.5% 5/326 • Number of events 5 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Hematoma	4.0% 13/326 • Number of events 13 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Myocardial Infarction	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Myocardial Perforation with tamponade	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Oozing/ bleeding	2.1% 7/326 • Number of events 7 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Pain (non-cardiovascular)	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Pericarditis	4.0% 13/326 • Number of events 13 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Phrenic Nerve Injury temporary	3.1% 10/326 • Number of events 10 • Through 12 Months	5.0% 3/60 • Number of events 3 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Pleuritis	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Post procedure infection/ Sepsis	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Post procedure wound discomfort	1.5% 5/326 • Number of events 5 • Through 12 Months	3.3% 2/60 • Number of events 2 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Procedure related allergic reactions/ adverse drug reaction	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Procedure related anesthesia/ sedation	0.61% 2/326 • Number of events 2 • Through 12 Months	1.7% 1/60 • Number of events 3 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Procedure related gastrointestinal	0.61% 2/326 • Number of events 2 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Procedure related hypertension	0.92% 3/326 • Number of events 3 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Procedure related Neurological (non-TIA, non-stroke, dysphagia, speech disturbance/ dysarthria)	1.2% 4/326 • Number of events 4 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Pulmonary Edema	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Surgical and medical procedures Right atrial (type 1) atrial flutter	0.31% 1/326 • Number of events 1 • Through 12 Months	0.00% 0/60 • Through 12 Months	0.00% 0/50 • Through 12 Months
Cardiac disorders Dyspnea	0.00% 0/326 • Through 12 Months	1.7% 1/60 • Number of events 1 • Through 12 Months	0.00% 0/50 • Through 12 Months

Additional Information

Stephanie Roelke, Clinical Trial Manager

Boston Scientific

Phone: 651-582-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER