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The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months.
The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Cohort | Experimental | Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Ablation | Procedure | In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite acute major adverse event rate | Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death. | 30-days post-procedure or hospital discharge (whichever is longer) |
| Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT) | Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy. | 6-months post-procedure to 12-months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Composite acute major adverse event rate (Safety) | Composite acute major adverse event rate at 6 months post-procedure (as defined above) | 6-months post-procedure |
| Composite acute major adverse event rate (Safety) |
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Inclusion Criteria:
History of non-paroxysmal AF (persistent or longstanding persistent)
Concomitant indication for non-emergent open-heart surgery, eg,
Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Yong | Contact | 763-526-2032 | stephanie.yong@medtronic.com | |
| Jessica Halverson | Contact | 763-514-9765 | Jessica.halverson@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Ralph J Damiano, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospitals and Clinic | Completed | Palo Alto | California | 94304 | United States | |
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| Cardioblate and Cryoflex hand held devices | Device | The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices. |
|
Composite acute major adverse event rate at 12 months post-procedure (as defined above)
| 12-months post-procedure |
| Percentage of new permanent pacemaker implantation (Safety) | Percentage of new permanent pacemaker implantation presented by indication | 12-months post-procedure |
| Acute procedural success (Efficacy) | Acute procedural success (pulmonary vein isolation) | During index procedure |
| Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy) | Freedom from AF/AFL/AT of 30 seconds or greater duration after removal from AAD therapy as assessed from the end of the 3-month blanking period through 6 months post-procedure | 6-months post-procedure |
| Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy) | Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 6 months post-procedure | 6-months post-procedure |
| Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy) | Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 12 months post-procedure | 12-months post-procedure |
| Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Quality of Life Score over time (Efficacy) | Characterization of quality of life scores over time as assessed by AFEQT questionnaire. AFEQT overall score ranges from 0-100. Zero corresponds to complete disability and 100 corresponds to no disability. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval. | 12-months post-procedure |
| SF-12 Health Survey (SF-12) Quality of Life Score over time (Efficacy) | Characterization of quality of life scores over time as assessed by SF-12 questionnaire. SF-12 overall score ranges from 0-100. Zero indicates the lowest level of health measured by the scale and 100 indicates the highest level of health. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval. | 12-months post-procedure |
| Adventist Health St. Helena |
| Withdrawn |
| St. Helena |
| California |
| 94574 |
| United States |
| Hartford Healthcare | Completed | Hartford | Connecticut | 06102 | United States |
| St Vincent Heart Center of Indiana | Recruiting | Indianapolis | Indiana | 46290 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
|
| ProMedica Toledo | Completed | Toledo | Ohio | 43606 | United States |
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| Lankenau Medical Center | Completed | Wynnewood | Pennsylvania | 19096 | United States |
| Intermountain Medical Center | Completed | Murray | Utah | 84107 | United States |
| Sentara Norfolk General Hospital | Completed | Norfolk | Virginia | 23507 | United States |
| Virginia Mason Heart Institute | Recruiting | Seattle | Washington | 98101 | United States |
|
| Swedish Medical Center | Recruiting | Seattle | Washington | 98122 | United States |
|
| St. Joseph Medical Center | Withdrawn | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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