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This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment patients | Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Cardiac Cryoablation System | Device | cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Event Free Rate | 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 | 12 months |
| Failure Free Rate | includes 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Documentation and Rate of Acute Procedural Success | Electrical 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. | Index Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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patients indicated for the treatment of AF with isolation of pulmonary veins technique according to current and future Guidelines and system indications for use
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Belgium | ||||
| Klinicki Bolnicki Centar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40108686 | Background | Luik A, Anic A, Martin CA, Tilz RR, Yap SC, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Defaye P. One-Year Success Rates of a Stable, Low Pressure Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation: Results of the Prospective, International, Multicenter POLAR ICE Study. J Cardiovasc Electrophysiol. 2025 May;36(5):1046-1052. doi: 10.1111/jce.16645. Epub 2025 Mar 19. | |
| 36786515 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes all treatment, attempt and intent subjects.
Excludes Consent Ineligible patient and one attempt subject who, at the time of study withdrawal also withdrew their consent to have data included in future analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safety Event Free Rate | 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 | Posted | Count of Participants | Participants | 12 months |
|
|
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 | 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:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 3rd degree AV block | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina/Chest pain | Injury, poisoning and procedural complications | Systematic Assessment | atypic thorax pain; Dyspnoe d'effort |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nele Cielen - Clinical Trial Manager | Boston Scientific | 0032470991143 | nele.cielen@bsci.com |
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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 | May 7, 2020 | May 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Split |
| Croatia |
| CHU De Brest - Hopital de la Cavale Blanche | Brest | France |
| CHU De Caen | Caen | France |
| CHU Grenoble - Hopital Michallon | Grenoble | France |
| Clinique Pasteur | Toulouse | France |
| CHRU Hospital Trousseau | Tours | France |
| Herz-und Diabeteszentrum Nordrhein-Westfalen | Bad Oeynhausen | Germany |
| Vivantes Klinikum Am Urban | Berlin | Germany |
| Staedtisches Klinikum Karlsruhe | Karlsruhe | Germany |
| Universitaetsklinikum Schleswig-Holstein | Lübeck | Germany |
| Maria Cecilia Hospital SPA | Cotignola | Italy |
| Centro Cardiologico Monzino | Milan | Italy |
| Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina | Roma | Italy |
| Erasmus MC | Rotterdam | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| Papworth Hospital | Cambridge | United Kingdom |
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | United Kingdom |
| Result |
| Martin CA, Tilz RRR, Anic A, Defaye P, Luik A, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Yap SC; POLAR ICE Investigators. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):833-840. doi: 10.1111/jce.15861. Epub 2023 Feb 23. |
| Treatment - End of study due to refusing testing COVID |
|
| Treatment - Death |
|
| Treatment - Withdrawn due to unknown reason |
|
| Consent Ineligible - Does not meet eligibility criteria |
|
| Attempt |
|
| Intent |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Failure Free Rate | includes 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Documentation and Rate of Acute Procedural Success | Electrical 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. | Posted | Count of Participants | Participants | Index Procedure |
|
|
|
| 1 |
| 399 |
| 71 |
| 399 |
| 47 |
| 399 |
| Angina/Chest pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Atrial Fibrillation (AF) | Cardiac disorders | Systematic Assessment | Including Atrial Fibrillation (AF) paroxysmal, AF persistent, AF recurrence, Atrial Tachycardia, hospital admission for AF |
|
| Implantation LBB Pacemaker | Cardiac disorders | Systematic Assessment |
|
| Atrial Flutter (AFl) | Cardiac disorders | Systematic Assessment | Including palpitations and hospital admissions |
|
| Atrial tachycardia/Other supraventricular tachycardia | Cardiac disorders | Systematic Assessment | AV-nodal re-entry tachycardia (AVNRT), supraventricular tachycardia |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Intestine Cancer, Lobectomy, Suspicion of a carcinoid in the intestine, uterus cancer surgery and whipple/ (Endoscopic retrograde cholangiopancreatography) ERCP |
|
| CerebroVascular Accident (CVA) | Vascular disorders | Systematic Assessment | benign paroxysmal position dizziness, ischemia |
|
| Chest Pain | General disorders | Systematic Assessment | Chest pain, instable angina pectoris |
|
| Coronary Artery Disease | Vascular disorders | Systematic Assessment | Coronary angiographia; electiv Recanalisation, actually without symptoms; Exclusion progress Coronary Artery Disease (CAD); Left main coronary artery intrastent restenosis |
|
| Dizziness | General disorders | Systematic Assessment | domestic fall in benign positional vertigo |
|
| Dyspnea - Heart Failure | Cardiac disorders | Systematic Assessment | Hisbundel Ablation |
|
| Embolism - Air | Injury, poisoning and procedural complications | Systematic Assessment | ST elevation during ablation procedure. |
|
| Endocrine | Endocrine disorders | Systematic Assessment | Hyperthyroid struma multinodosa both sides; Parathyroidectomie |
|
| COVID19 infection | Infections and infestations | Systematic Assessment |
|
| Fistula (Aterial/Venous) | Injury, poisoning and procedural complications | Systematic Assessment | Arteriovenous fistula; Fistula; Pain on the right femoral fistula; Right femoral arterio-venous fistula with hematoma |
|
| Gastritis | Injury, poisoning and procedural complications | Systematic Assessment | Dyspnoe |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | abdominal abces; Abdominal pain right lower abdomen; ileus, hernia umbilicalis; suspected appendicitis |
|
| Genitourinary | Renal and urinary disorders | Systematic Assessment | urinary bladder tumor resection |
|
| Head, Eyes, Ears, Nose, Throat (HEENT) | General disorders | Systematic Assessment | Cholesteatom right; nervus opticus inflammation; |
|
| Heart Failure symptoms - Unspecified | Cardiac disorders | Systematic Assessment | CRT-D (cardiac resynchronization therapy - defibrillator) implant; worsening heart failure |
|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment | Anemia |
|
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment | IHematoma, hematoma inguinal area, subcutaneous hematoma |
|
| Hypertension/Hypertensive Crisis | Vascular disorders | Systematic Assessment | Hypertensive derailement |
|
| Integumentary | Skin and subcutaneous tissue disorders | Systematic Assessment | Fever, melanoma of the skin |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | carpal tunnel syndrom |
|
| Myocardial Infarction | Injury, poisoning and procedural complications | Systematic Assessment | Post interventional STEMI (ST segment elevation myocardial infarction) |
|
| Myocardial perforation with tamponade | Injury, poisoning and procedural complications | Systematic Assessment | drained tamponade, pericardial effusion |
|
| non-sustained ventricular tachycardia | Cardiac disorders | Systematic Assessment | ICD (implantable cardioverter defibrillator) Shock |
|
| Oozing/Bleeding | Injury, poisoning and procedural complications | Systematic Assessment | Bleeding; Groin access site hematoma |
|
| Non Cardiovascular Pain | Injury, poisoning and procedural complications | Systematic Assessment | chest pain due to gastric problems |
|
| Pericardial effusion | Injury, poisoning and procedural complications | Systematic Assessment | right ventricular effusion |
|
| Phrenic nerve injury temporary | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Physical trauma | General disorders | Systematic Assessment | Hand Fracture; Fracture of the neck and femur; right upper and lower limb motor deficit; spinal fracture following trauma; wound dehiscence |
|
| Procedure related Allergic reactions/Adverse drug reaction | Injury, poisoning and procedural complications | Systematic Assessment | Bradycardy, Dizziness; Bronchospasm |
|
| Procedure related Pulmonary (including cough, hemoptysis) | Injury, poisoning and procedural complications | Systematic Assessment | Hospital admission with AF,heamoptysis and fever |
|
| Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | acute dyspnea; Pneumonia with exacerbated COPD (Chronic Obstructive Pulmonary Disease); pneumopathy |
|
| Left renal colic | Renal and urinary disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Stroke | Injury, poisoning and procedural complications | Systematic Assessment | cerebellar infarctation left |
|
| Syncope | General disorders | Systematic Assessment |
|
| Thrombus | Injury, poisoning and procedural complications | Systematic Assessment | Femoral vein thrombosis |
|
| Transient Ischemic Attack (TIA) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pectoralis twitching due to pacemaker | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ventricular Tachycardia (VT)/Monomorphic VT | Cardiac disorders | Systematic Assessment |
|
| Vessel trauma | Injury, poisoning and procedural complications | Systematic Assessment | hematic leakage from collateral femoral artery |
|
|
| Atrial Fibrillation (AF) | Cardiac disorders | Systematic Assessment | Atrial fibrillation (AF); Hospital admission with AF; repeat ablation procedure |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment | tachycardia-like palpitations; Atrial flutter; Atypical Atrial flutter |
|
| Deep Vein Thrombosis (DVT) | Vascular disorders | Systematic Assessment |
|
| Dyspnea - Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Embolism - Air | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gastritis | Injury, poisoning and procedural complications | Systematic Assessment | stomach ache; GERD (Gastroesophageal reflux disease) exacerbation |
|
| Gastroparesis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hoarse Voice | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Oozing/Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain (Non-cardiovascular) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain cardiovascular (Non-ischemic) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pericarditis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Phrenic nerve injury permanent | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Phrenic nerve injury temporary | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedure related Allergic reactions/Adverse drug reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedure related Anesthesia/Sedation | Injury, poisoning and procedural complications | Systematic Assessment | Keratitis |
|
| Procedure related Gastrointestinal | Injury, poisoning and procedural complications | Systematic Assessment | Abdominal pain |
|
| Procedure related Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria) | Injury, poisoning and procedural complications | Systematic Assessment | visual disturbance; migraine |
|
| Procedure related Pulmonary (including cough, hemoptysis) | Injury, poisoning and procedural complications | Systematic Assessment | Dyspnoe, hemoptysis |
|
| Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Psychological issues related to Phrenic Nerve Injury (PNI) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Visual blurring/Disturbances | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |