Heart Failure
Conditions
Brief summary
Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
Detailed description
The WiSE-UP Study 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.
Interventions
DEVICEThe Wise System
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.
Sponsors
EBR Systems, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient or legally authorized representative can provide written authorization and/or consent per institution requirements. * Patient is intended to receive a WiSE System and passed the acoustic window screening * Patient who is, or will be, accessible for follow-up. * Participation is not excluded by local law. * Patient is not enrolled in a concurrent drug and/or device study that may confound the Registry results. * Patient life expectancy \>1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety | 1, 6, 12, 24, 48 and 60 months | The primary outcome measure of the Study is the rate of serious adverse events (SAEs) at \< 30 days post implant related to the WiSE System and/or implant procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy 1 | 1 month | Procedural Success of the Leadless LV endocardial pacing (LVEP) |
| Efficacy 2 | 1 month | CRT response assessment of NYHA functional classification |
| Efficacy 3 | 6 months | Left ventricular ejection fraction (LVEF) |
| Efficacy 4 | 6 months | Left ventricular and systolic volume (LVESV) |
| Efficacy 5 | 1, 6, 12, 24, 48 and 60 months | Heart failure clinical composite score (HF CCS) categorizing patients as improved, unchanged or worsened |
| Efficacy 6 | 1, 6, 12, 24, 48 and 60 months | New York Heart Association (NYHA) classification values of Markedly improved, Moderately improved, Mild improvement, No change or Slightly worse |
| Efficacy 7 | 1, 6, 12, 24, 48 and 60 months | QRS duration |
| Efficacy 8 | 6 and 12 months | 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 |
| Efficacy 9 | 1, 6, 12, 24, 48 and 60 months | Events assessment: confirmation of reportable events including updates to any previously reported events |
| Efficacy 10 | 1, 6, 12, 24, 48 and 60 months | Mortality is based on an estimated 1-year rate of 10%- and 1-year attrition of up to 15% |
| Efficacy 11 | 1, 6, 12, 24, 48 and 60 months | Patient global assessment |
Countries
United States
Contacts
CONTACTJamie Burke
Outcome results
None listed