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| Name | Class |
|---|---|
| Cryterion Medical, Inc. | INDUSTRY |
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Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
This is a single-arm, open-label clinical study using a cryoablation balloon device to isolate pulmonary veins during an atrial fibrillation ablation procedure. Cryo is a scientifically proven energy source used to create a thermal injury during endocardial ablation. The investigational device uses current technology with minor design modifications and will be studied to validate similarities in the safety and performance parameters compared to literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PV Cryoablation | Experimental | Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Cryterion Cardiac Cryoablation System | Device | Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects | Percentage of participants with procedure related adverse events OR device related adverse events OR Serious Adverse device effects including: Death, Myocardial Infarction, Cardiac perforation/pericardial tamponade, Cerebral Infarct or systemic embolism, Major bleeding requiring transfusion of blood products, Mitral or tricuspid valvular damage, phrenic nerve damage causing persistent diaphragmatic paralysis, Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, Air embolism leading to life-threatening event, other serious adverse device effects (SADEs) | 12 months |
| Acute Procedural Success | Percentage of patients achieving pulmonary vein isolation defined as entrance and exit block for each of the targeted pulmonary veins following the last ablation application. | Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes. |
| 12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months | A treatment failure is defined as a subject being an acute procedural failure, having more than one repeat procedure during the 90-day blanking period or having a documented, symptomatic episode(s) of atrial fibrillation or atrial tachycardia, between 91 and 365 days post index procedure. Occurrence or recurrence of a right atrial arrhythmia is not considered a treatment failure post the 90-day blanking period | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events. | All procedure-related or device related adverse events with causal relationship | 12 months |
| Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarfaraz Taher | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital Centre Split | Split | Croatia | ||||
| Catharina Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33729470 | Background | Anic A, Lever N, Martin A, Breskovic T, Sulkin MS, Duffy E, Saliba WI, Niebauer MJ, Wazni OM, Varma N. Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience. Europace. 2021 Aug 6;23(8):1237-1243. doi: 10.1093/europace/euab018. | |
| 35412168 |
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| ID | Title | Description |
|---|---|---|
| FG000 | PV Cryoablation | Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PV Cryoablation | Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the 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 | Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects | Percentage of participants with procedure related adverse events OR device related adverse events OR Serious Adverse device effects including: Death, Myocardial Infarction, Cardiac perforation/pericardial tamponade, Cerebral Infarct or systemic embolism, Major bleeding requiring transfusion of blood products, Mitral or tricuspid valvular damage, phrenic nerve damage causing persistent diaphragmatic paralysis, Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, Air embolism leading to life-threatening event, other serious adverse device effects (SADEs) | 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 | PV Cryoablation | Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Episodic aphasia | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post surgical wound discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Boston Scientific | +32 470 991143 | 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 | Yes | No | No | Study Protocol | Sep 4, 2019 | May 20, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2021 | Jun 24, 2021 | SAP_001.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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Non-randomized study designed to validate the safety and performance of the Cryterion Cardiac Cryoablation System when used as intended
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|
Percentage of subjects that present PV isolation immediately after ablation but show reconnection after 30 minutes during entrance/exit block testing. This outcome is only measured in subjects that were enrolled under the protocol that required a 30 minute waiting period between isolation and verification of isolation. |
| 30 minutes |
| Eindhoven |
| Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| Auckland City Hospital | Auckland | New Zealand |
| Martin A, Fowler M, Breskovic T, Ouss A, Dekker L, Yap SC, Bhagwandien R, Albrecht EM, Cielen N, Richards E, Tran BC, Lever N, Anic A. Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study. J Interv Card Electrophysiol. 2022 Dec;65(3):609-616. doi: 10.1007/s10840-022-01200-5. Epub 2022 Apr 12. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Acute Procedural Success | Percentage of patients achieving pulmonary vein isolation defined as entrance and exit block for each of the targeted pulmonary veins following the last ablation application. | Posted | Count of Participants | Participants | Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes. |
|
|
|
| Primary | 12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months | A treatment failure is defined as a subject being an acute procedural failure, having more than one repeat procedure during the 90-day blanking period or having a documented, symptomatic episode(s) of atrial fibrillation or atrial tachycardia, between 91 and 365 days post index procedure. Occurrence or recurrence of a right atrial arrhythmia is not considered a treatment failure post the 90-day blanking period | In total, 88 subjects were enrolled. Six subjects ended the study at the one month follow-up visit and were therefore not eligible for the analysis. Of the 3 subjects that were withdrawn prior to study completion, one subject experienced a recurrence before being withdrawn and was therefore included in the analysis. The two other subjects were event free at time of study withdrawal. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events. | All procedure-related or device related adverse events with causal relationship | Causally related to procedure | Posted | Number | Adverse Events | 12 months |
|
|
|
| Secondary | Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing | Percentage of subjects that present PV isolation immediately after ablation but show reconnection after 30 minutes during entrance/exit block testing. This outcome is only measured in subjects that were enrolled under the protocol that required a 30 minute waiting period between isolation and verification of isolation. | Out of 88 subjects enrolled in the study, 54 subjects have been enrolled under the protocol requiring a 30 minute waiting period between pulmonary vein isolation and entrance/exit block testing. All subjects for whom at least one additional application was performed minimally 30 minutes after the previous ablation, were considered having a potential reconnection during entrance/exit block testing. | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| 0 |
| 88 |
| 6 |
| 88 |
| 56 |
| 88 |
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
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| Cholelithiasis | Gastrointestinal disorders | Systematic Assessment |
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| Embolism in right femoral artery | Vascular disorders | Systematic Assessment |
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| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Minor oozing/bleeding | Vascular disorders | Systematic Assessment |
|
| Angina/Chest pain | Cardiac disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Nerve (weakness, palsy) | Nervous system disorders | Systematic Assessment |
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| Adverse reactions | General disorders | Systematic Assessment | Intermittent fever and coughing |
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| Adverse reaction - hypotension | Cardiac disorders | Systematic Assessment |
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| Adverse reaction - neurological | Nervous system disorders | Systematic Assessment | Migraine |
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| Adverse reaction Anesthesia/sedation | Gastrointestinal disorders | Systematic Assessment | Nausea |
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| Adverse reaction - gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Gastric reflux, vomitting, nausea |
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| Adverse reaction - pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dyspnea |
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| Sore Throat post procedure | Injury, poisoning and procedural complications | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Syncope | Cardiac disorders | Systematic Assessment |
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| Diziness | Cardiac disorders | Systematic Assessment |
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| Chest Pain | Cardiac disorders | Systematic Assessment |
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| Dyspnea | Cardiac disorders | Systematic Assessment |
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| Fatigue/Weakness | Cardiac disorders | Systematic Assessment |
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| Inability to palpate peripheral arterial pulse | Cardiac disorders | Systematic Assessment |
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| CVA | Cardiac disorders | Systematic Assessment |
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| Adverse Reaction - Urticaria | General disorders | Systematic Assessment |
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| Adverse Reaction - Medication | General disorders | Systematic Assessment |
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| Hipoechogenic lesion in left breast | General disorders | Systematic Assessment |
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| Fever - Virus | Infections and infestations | Systematic Assessment |
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| Ankle Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypersaturation with warfarin | Blood and lymphatic system disorders | Systematic Assessment |
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| Elevated level Thyroid function (T4) | Endocrine disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Shinlges | Nervous system disorders | Systematic Assessment | Rash due to shingles (viral infection that causes a painful rash) on the back |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | Systematic Assessment |
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| Polipectomy | Gastrointestinal disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Polyp in acsending colon | Gastrointestinal disorders | Systematic Assessment |
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| Urinary Infection | Renal and urinary disorders | Systematic Assessment |
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| Positive urine culture | Renal and urinary disorders | Systematic Assessment |
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| Benign renal cyst L) kidney | Renal and urinary disorders | Systematic Assessment |
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| Muskuloskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Chest and neck pain, knee pain, |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Epistaxis | Vascular disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Conjunctavitis | Eye disorders | Systematic Assessment |
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| Type 2 Diabetes Mellitus | Endocrine disorders | Systematic Assessment |
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| Follicular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Haematoma of the right upper arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| sinusitis | Infections and infestations | Systematic Assessment |
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| Tooth Pain | Gastrointestinal disorders | Systematic Assessment |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |