Recruiting

Observational Study

Sponsor:

EBR Systems, Inc.

Code:

NCT07098858

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

The Wise System

Study Details

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

Conditions

Heart Failure

Study ID

NCT07098858

Start date

Nov 3, 2025

Status verified date

Feb, 2026

Completion date

Sep 30, 2032

Anticipated

Primary completion date

Sep 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

320 participants

Anticipated

Interventions and Outcome Measures

Arms

Single-arm, prospective, multicenter, observational study.

Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible.

Interventions

The 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.

Primary outcome measure

  • Primary Safety [ Time Frame: 1, 6, 12, 24, 48 and 60 months ]

Central Contacts and Locations

Central contacts

Jamie Burke

17194644185clinical@ebrwise.com

Locations

Arrhythmia Research Group (St. Bernards Hospital)

Recruiting

Jonesboro, Arkansas, United States, 72404

Contacts

Kayla Rubino

krubino@dnairresearch.com

Principal Investigator:

Devi Nair

Naples Community Hospital

Recruiting

Naples, Florida, United States, 34102

Contacts

Linda Pastorious

linda.pastorius@nchmd.org

Principal Investigator:

Dinesh Sharma

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48107

Contacts

Kirsta Bray

kibray@ebrwise.com

Principal Investigator:

Jackson Liang, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Ruwanthi J Perera

rjj4002@med.cornell.edu

Principal Investigator:

James IP, MD

Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

Soraya Sami, MD

More Information

Sponsor

EBR Systems, Inc.

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by EBR Systems, Inc. on 2026-02-13.