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This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this study will be used for submission to regulatory authorities in Europe, China and other geographies as needed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Ablation | Device | The AtriCure cryoICE® cryoFORMTM cryoablation probe is used in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events. | Death, stroke (regardless of level of disability), myocardial infarction, and major bleeding events within 30-days of the index ablation procedure. Measured by number of patients with Treatment-Related Adverse Events. | 30 days post procedure |
| Freedom From Any Documented AF, AFL or AT Lasting >30 Seconds in the Duration of the Last Follow-up Visit Off Antiarrhythmic Therapy (Except of AADs at Doses Not Exceeding Those Previously Failed | Freedom from any documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) lasting >30 seconds in duration at the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed). Measured by 24-hour Holter Monitoring. | 12-24 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless of Class I or III AADs | Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit regardless of Class I or III AADs. | 12-24 months post procedure |
| Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit in the Absence of Class I or III AADs. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Pacemaker Implant or Overall Device or Surgical Ablation Procedures Related to Adverse Events | Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events | 12-24 months post procedure |
Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06106 | United States | ||
| Yale University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Randomized, Single Arm Study | Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Randomized, Single Arm Study | Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria. |
| 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 | Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events. | Death, stroke (regardless of level of disability), myocardial infarction, and major bleeding events within 30-days of the index ablation procedure. Measured by number of patients with Treatment-Related Adverse Events. | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
At time of procedure
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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 | Non-Randomized, Single Arm Study | Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complete Heart Block | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nfii Ndikintum, VP of Clinical Affairs and Biometerics | AtriCure | 5136448192 | NNdikintum@atricure.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 | Aug 2, 2021 | Nov 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit in the absence of Class I or III AADs. |
| 12-24 months post procedure |
| Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure. | Acute procedural success defined as documentation of sinus rhythm at the end of the procedure. | At end of procedure |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Saint Thomas West Hospital | Nashville | Tennessee | 37205 | United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria. | Mean | Full Range | years |
|
| Sex: Female, Male | Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Freedom From Any Documented AF, AFL or AT Lasting >30 Seconds in the Duration of the Last Follow-up Visit Off Antiarrhythmic Therapy (Except of AADs at Doses Not Exceeding Those Previously Failed | Freedom from any documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) lasting >30 seconds in duration at the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed). Measured by 24-hour Holter Monitoring. | Posted | Count of Participants | Participants | 12-24 months post procedure |
|
|
|
| Secondary | Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless of Class I or III AADs | Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit regardless of Class I or III AADs. | Not Posted | 12-24 months post procedure | Participants |
| Secondary | Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit in the Absence of Class I or III AADs. | Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit in the absence of Class I or III AADs. | Not Posted | 12-24 months post procedure | Participants |
| Secondary | Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure. | Acute procedural success defined as documentation of sinus rhythm at the end of the procedure. | Not Posted | At end of procedure | Participants |
| Other Pre-specified | Freedom From Pacemaker Implant or Overall Device or Surgical Ablation Procedures Related to Adverse Events | Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events | Not Posted | 12-24 months post procedure | Participants |
| 0 |
| 33 |
| 12 |
| 33 |
| 0 |
| 33 |
| Aneurysm | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular Block | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment |
|
| Other | Cardiac disorders | Systematic Assessment |
|
| Other | Metabolism and nutrition disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |