Trial Outcomes & Findings for POLARx Cardiac Cryoablation System Study (NCT NCT04250714)
NCT ID: NCT04250714
Last Updated: 2025-04-04
Results Overview
Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis
Recruitment status
COMPLETED
Target enrollment
400 participants
Primary outcome timeframe
12 months
Results posted on
2025-04-04
Participant Flow
Participant milestones
| Measure |
Enrolled Patients
Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use
Boston Scientific Cardiac Cryoablation System: cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
The enrolled patients will further be divided into:
1. Treatment subjects (Followed for 12 months)
2. Attempt subjects (study device inserted but not ablation treatment received)
3. Intent subjects (study device not inserted)
4. Consent ineligible (no meeting eligibility criteria after enrollment)
|
|---|---|
|
Overall Study
STARTED
|
400
|
|
Overall Study
COMPLETED
|
359
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Enrolled Patients
Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use
Boston Scientific Cardiac Cryoablation System: cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
The enrolled patients will further be divided into:
1. Treatment subjects (Followed for 12 months)
2. Attempt subjects (study device inserted but not ablation treatment received)
3. Intent subjects (study device not inserted)
4. Consent ineligible (no meeting eligibility criteria after enrollment)
|
|---|---|
|
Overall Study
Treatment - withdrawal by subject
|
14
|
|
Overall Study
Treatment - Lost to Follow-up
|
11
|
|
Overall Study
Treatment - End of study due to logistical reasons
|
2
|
|
Overall Study
Treatment - End of study due to refusing testing COVID
|
1
|
|
Overall Study
Treatment - Death
|
1
|
|
Overall Study
Treatment - Withdrawn due to unknown reason
|
2
|
|
Overall Study
Consent Ineligible - Does not meet eligibility criteria
|
1
|
|
Overall Study
Attempt
|
2
|
|
Overall Study
Intent
|
7
|
Baseline Characteristics
POLARx Cardiac Cryoablation System Study
Baseline characteristics by cohort
| Measure |
Enrolled Patients
n=398 Participants
Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use
Boston Scientific Cardiac Cryoablation System: cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
256 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Disclosed
|
140 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
45 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
54 participants
n=5 Participants
|
|
Region of Enrollment
France
|
109 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
105 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsFreedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis
Outcome measures
| Measure |
Primary Safety Endpoint
n=391 Participants
The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects.
|
|---|---|
|
Safety Event Free Rate
|
373 Participants
|
PRIMARY outcome
Timeframe: 12 monthsincludes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure
Outcome measures
| Measure |
Primary Safety Endpoint
n=355 Participants
The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects.
|
|---|---|
|
Failure Free Rate
|
223 Participants
|
SECONDARY outcome
Timeframe: Index ProcedureElectrical isolation of a pulmonary vein (PV) is demonstrated at minimum by entrance block using the Cryo Mapping Catheter. The Secondary Effectiveness Endpoint is analyzed using data from all TREATMENT subjects.
Outcome measures
| Measure |
Primary Safety Endpoint
n=390 Participants
The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects.
|
|---|---|
|
Documentation and Rate of Acute Procedural Success
|
359 Participants
|
Adverse Events
Enrolled Patients
Serious events: 71 serious events
Other events: 47 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Enrolled Patients
n=399 participants at risk
Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use
Boston Scientific Cardiac Cryoablation System: cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
The enrolled patients will further be divided into:
1. Treatment subjects (Followed for 12 months)
2. Attempt subjects (study device inserted but not ablation treatment received)
3. Intent subjects (study device not inserted)
4. Consent ineligible (no meeting eligibility criteria after enrollment)
|
|---|---|
|
Cardiac disorders
3rd degree AV block
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Angina/Chest pain
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
4.3%
17/399 • Number of events 18 • 12 months
|
|
Cardiac disorders
Implantation LBB Pacemaker
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial Flutter (AFl)
|
1.0%
4/399 • Number of events 5 • 12 months
|
|
Cardiac disorders
Atrial tachycardia/Other supraventricular tachycardia
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.0%
4/399 • Number of events 5 • 12 months
|
|
Vascular disorders
CerebroVascular Accident (CVA)
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
General disorders
Chest Pain
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Vascular disorders
Coronary Artery Disease
|
1.0%
4/399 • Number of events 4 • 12 months
|
|
General disorders
Dizziness
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Embolism - Air
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Endocrine disorders
Endocrine
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Infections and infestations
COVID19 infection
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Fistula (Aterial/Venous)
|
0.75%
3/399 • Number of events 4 • 12 months
|
|
Injury, poisoning and procedural complications
Gastritis
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.0%
4/399 • Number of events 4 • 12 months
|
|
Renal and urinary disorders
Genitourinary
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
General disorders
Head, Eyes, Ears, Nose, Throat (HEENT)
|
0.50%
2/399 • Number of events 3 • 12 months
|
|
Cardiac disorders
Heart Failure symptoms - Unspecified
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Hematological
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.75%
3/399 • Number of events 3 • 12 months
|
|
Vascular disorders
Hypertension/Hypertensive Crisis
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Myocardial Infarction
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Myocardial perforation with tamponade
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Cardiac disorders
non-sustained ventricular tachycardia
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Oozing/Bleeding
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Non Cardiovascular Pain
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pericardial effusion
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Phrenic nerve injury temporary
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
General disorders
Physical trauma
|
1.0%
4/399 • Number of events 5 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Allergic reactions/Adverse drug reaction
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Pulmonary (including cough, hemoptysis)
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.50%
2/399 • Number of events 3 • 12 months
|
|
Renal and urinary disorders
Left renal colic
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Stroke
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
General disorders
Syncope
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Thrombus
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Transient Ischemic Attack (TIA)
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pectoralis twitching due to pacemaker
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vessel trauma
|
0.25%
1/399 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Enrolled Patients
n=399 participants at risk
Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use
Boston Scientific Cardiac Cryoablation System: cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
The enrolled patients will further be divided into:
1. Treatment subjects (Followed for 12 months)
2. Attempt subjects (study device inserted but not ablation treatment received)
3. Intent subjects (study device not inserted)
4. Consent ineligible (no meeting eligibility criteria after enrollment)
|
|---|---|
|
Injury, poisoning and procedural complications
Angina/Chest pain
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
1.0%
4/399 • Number of events 4 • 12 months
|
|
Cardiac disorders
Atrial flutter
|
0.75%
3/399 • Number of events 3 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis (DVT)
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Embolism - Air
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Gastritis
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Gastroparesis
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Hematoma
|
1.5%
6/399 • Number of events 6 • 12 months
|
|
Injury, poisoning and procedural complications
Hoarse Voice
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Oozing/Bleeding
|
0.75%
3/399 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Pain (Non-cardiovascular)
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pain cardiovascular (Non-ischemic)
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pericarditis
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Phrenic nerve injury permanent
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Phrenic nerve injury temporary
|
1.8%
7/399 • Number of events 7 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Allergic reactions/Adverse drug reaction
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Anesthesia/Sedation
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Gastrointestinal
|
0.50%
2/399 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Hypotension
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria)
|
0.75%
3/399 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Procedure related Pulmonary (including cough, hemoptysis)
|
0.75%
3/399 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Psychological issues related to Phrenic Nerve Injury (PNI)
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.25%
1/399 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Visual blurring/Disturbances
|
0.25%
1/399 • Number of events 1 • 12 months
|
Additional Information
Nele Cielen - Clinical Trial Manager
Boston Scientific
Phone: 0032470991143
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place