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Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
The WiSE-UP Registry is a prospective, real-world, observational study aimed at understanding acute and long-term product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm, prospective, multicenter, observational study. | Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Wise System | Device | The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety | The primary outcome measure of the Registry is the rate of serious adverse events (SAEs) at < 30 days post implant related to the WiSE System and/or implant procedure. | 1, 6, 12, 24, 48 and 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy 1 | Procedural Success of the Leadless LV endocardial pacing (LVEP) | 1 month |
| Efficacy 2 | CRT response assessment of NYHA functional classification |
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Up to 320 patients will be enrolled in the registry and followed for five years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Burke | Contact | 17194644185 | clinical@ebrwise.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Research Group (St. Bernards Hospital) | Recruiting | Jonesboro | Arkansas | 72404 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 month |
| Efficacy 3 | Left ventricular ejection fraction (LVEF) | 6 months |
| Efficacy 4 | Left ventricular and systolic volume (LVESV) | 6 months |
| Efficacy 5 | Heart failure clinical composite score (HF CCS) categorizing patients as improved, unchanged or worsened | 1, 6, 12, 24, 48 and 60 months |
| Efficacy 6 | New York Heart Association (NYHA) classification values of Markedly improved, Moderately improved, Mild improvement, No change or Slightly worse | 1, 6, 12, 24, 48 and 60 months |
| Efficacy 7 | QRS duration | 1, 6, 12, 24, 48 and 60 months |
| Efficacy 8 | Minnesota Living with Heart Failure Questionnaire (MLHFQ) a validated tool designed to assess the impact of heart failure on a patient's quality of life | 6 and 12 months |
| Efficacy 9 | Events assessment: confirmation of reportable events including updates to any previously reported events | 1, 6, 12, 24, 48 and 60 months |
| Efficacy 10 | Mortality is based on an estimated 1-year rate of 10%- and 1-year attrition of up to 15% | 1, 6, 12, 24, 48 and 60 months |
| Efficacy 11 | Patient global assessment | 1, 6, 12, 24, 48 and 60 months |
| Naples Community Hospital | Recruiting | Naples | Florida | 34102 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48107 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
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| Penn State Health | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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