Heart FailureNCT07098858
The WiSE®-UP Study (The WiSE System Utilization & Performance Study)
An observational study of Heart Failure, run by EBR Systems, Inc. at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- The Wise System
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 12 sitesUnited States
- Study dates
- 3 Nov 2025to 30 Sep 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 320 patients will be enrolled in the study and followed for five years.
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48107
Kirsta Bray, kibray@ebrwise.com
Jackson Liang, DO
- Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Deb Cardinal, dscardinal@austinheartbeat.com
J.David Burkhardt, MD
- Recruiting
MUSC
Charleston, South Carolina, 29245
Krista Szymanski, szymankr@musc.edu
Anne Kroman, DO
- Recruiting
UVA
Charlottesville, Virginia, 22903
Abbey Ferguson, SYE4VN@uvahealth.org
Kenneth Bilchick, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Danielle Liggett, LIGGETD2@ccf.org
Niraj Varma, MD
- Recruiting
Penn State Health
Hershey, Pennsylvania, 17033
LIsa Fox, lfox5@pennstatehealth.psu.edu
Soraya Sami, MD
- Recruiting
Arrhythmia Research Group (St. Bernards Hospital)
Jonesboro, Arkansas, 72404
Kayla Rubino, krubino@dnairresearch.com
Devi Nair, MD
- Recruiting
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Susan Ehlert, susan.ehlert@bjc.org
Daniel Steinhaus, MD
- Recruiting
CardioVascular Associates of Mesa (CVAM)
Mesa, Arizona, 85206
Adam Gitkin, agitkin@cvam.com
Ambrose Panico, DO
- Recruiting
Naples Community Hospital
Naples, Florida, 34102
Linda Pastorious, linda.pastorius@nchmd.org
Dinesh Sharma, MD
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Ruwanthi J Perera, rjj4002@med.cornell.edu
James IP, MD
- Recruiting
Honor Health
Scottsdale, Arizona, 85258
Kathrina Spencer, kestrada@honorhealth.com
Rahul N. Doshi, MD
About this study
Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
Read the 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.
- Conditions
- Heart Failure
- Being tested
- The Wise System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Wise SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, prospective, multicenter, observational study. | Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible. Receives: Device: The Wise System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety
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.
Measured: 1, 6, 12, 24, 48 and 60 months
Secondary outcomes (11)
Efficacy 1
Procedural Success of the Leadless LV endocardial pacing (LVEP)
Measured: 1 month
Efficacy 2
CRT response assessment of NYHA functional classification
Measured: 1 month
Efficacy 3
Left ventricular ejection fraction (LVEF)
Measured: 6 months
Efficacy 4
Left ventricular and systolic volume (LVESV)
Measured: 6 months
Efficacy 5
Heart failure clinical composite score (HF CCS) categorizing patients as improved, unchanged or worsened
Measured: 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
Measured: 1, 6, 12, 24, 48 and 60 months
Efficacy 7
QRS duration
Measured: 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
Measured: 6 and 12 months
Efficacy 9
Events assessment: confirmation of reportable events including updates to any previously reported events
Measured: 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%
Measured: 1, 6, 12, 24, 48 and 60 months
Efficacy 11
Patient global assessment
Measured: 1, 6, 12, 24, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start3 Nov 2025
- Primary completion30 Sep 2032 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- EBR Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098858
- Sponsor's protocol ID
- CSP-10005
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WiSE®-UP Study (The WiSE System Utilization & Performance Study)
- ClinicalTrials.gov ID
- NCT07098858
- Acronym / sponsor ID
- CSP-10005
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- EBR Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 30 Sep 2032 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm, prospective, multicenter, observational study. | – | Device: The Wise SystemMarket-released WiSE System approved for commercial release with a market-released co-implanted system are eligible. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 320 patients will be enrolled in the study and followed for five years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Wise SystemThe 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. | Device | Single-arm, prospective, multicenter, observational study. |
Primary outcome
Primary Safety
Time frame: 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.
11 secondary outcomes
Efficacy 1
Time frame: 1 month
Efficacy 2
Time frame: 1 month
Efficacy 3
Time frame: 6 months
Efficacy 4
Time frame: 6 months
Efficacy 5
Time frame: 1, 6, 12, 24, 48 and 60 months
Efficacy 6
Time frame: 1, 6, 12, 24, 48 and 60 months
Efficacy 7
Time frame: 1, 6, 12, 24, 48 and 60 months
Efficacy 8
Time frame: 6 and 12 months
Efficacy 9
Time frame: 1, 6, 12, 24, 48 and 60 months
Efficacy 10
Time frame: 1, 6, 12, 24, 48 and 60 months
Efficacy 11
Time frame: 1, 6, 12, 24, 48 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by EBR Systems, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Burke (408-720-1906, clinical@ebrwise.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety (time frame: 1, 6, 12, 24, 48 and 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.