WiCS-LV Post Market Surveillance Registry

NCT02610673 | Active Not Recruiting

• 1 other identifier: EBR-02821
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

This is an observational, prospective, non-randomized collection of defined clinical data under normal conditions of use for the WiCS-LV System, an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead. Patients will be enrolled and followed according to standard of care for 5 years.

Conditions

Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (2)

• Complications

  Device and procedure related complications

  24 hour perioperative, one month

• Performance

  Bi-ventricular capture on 12 lead EKG

  six months

Secondary Outcomes (5)

• Device Complications

  six months

• Major Complications

  six months

• Complications

  annually to 5 years

• Performance

  annually to 5 years

• Evidence of Efficacy

  6 months

Interventions

WiCS-LV System DEVICE

Implant of left ventricular receiver-electrode and ultrasound transmitter.

Also known as: Wireless Cardiac Stimulation, Wireless Stimulation on the Endocardium - WiSE System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure meeting standard criteria for CRT based upon the current European Society of Cardiology / European Heart Rhythm Association (ESC/EHRA) guidelines and meeting inclusion criteria.

You may qualify if:

• Patients with heart failure meeting standard criteria for CRT based upon the current European Society of Cardiology / European Heart Rhythm Association (ESC/EHRA) guidelines and meeting criteria in one of these categorizations:
• Untreated by conventional CRT:
• This includes:
• Patients that have had an attempted but failed CS lead implant due to such complications as venous occlusion, difficult CS access or anatomy, poor lead stability or previous CS repositioning procedures.
• Patients with a previously implanted CS lead that is programmed off due to such complications as high pacing threshold, non-capture, phrenic nerve stimulation, lead failure, lead dislodgement, or other justifications due to lead issues documented by the prescribing physician.
• Non-responder to conventional CRT
• This includes:
• Patients with a previously implanted CRT device who based on prescribing physician judgment experience no change or worsening of heart failure symptoms or no change or worsening of NYHA functional class after 6 months of CRT treatment.
• Upgrade:
• This includes:
• Patients that have a relative contraindication for a CS lead implant such as difficult subclavian access, venous thrombosis, venous occlusion, risk of lead dislodgment, or other justification documented by the prescribing physician.
• Patients that have a relative contraindication for revising an implanted device to a CRT device such as previous pocket erosion, previous pocket infection, previous explantations, or other justifications documented by the prescribing physicians.
• Patients with other justifications based upon the prescribing physician's judgment of risk to reopening the device pocket including consideration for the remaining longevity of the pacemaker/ICD battery.

You may not qualify if:

• Triple anticoagulation therapy (warfarin, clopidogrel, ASA, or other agents) Stage 4 or 5 renal dysfunction defined as GFR \<30 Grade 4 mitral valve regurgitation Thrombocytopenia (platelet count \<150,000) Non-ambulatory (or unstable) NYHA class 4 Contraindication to heparin Contraindication to both chronic anticoagulants and antiplatelet agents Contraindication to iodinated contrast agents Insufficient acoustic window to the LV as assessed from diagnostic transthoracic echocardiography Left atrial or left ventricular thrombus Attempted implant of a Pacemaker, ICD, or CRT device within 3 days Life expectancy \< 12 months Chronic hemodialysis Myocardial infarction within one month Major cardiac surgery within one month Incompatible electrical stimulation therapy devices, for example transcutaneous electrical nerve stimulation (TENS) or other neurological stimulation devices Exposure to magnetic resonance imaging (MRI) Use of diathermy Use of therapeutic ultrasound Use of echocardiography imaging using vascular, intracardiac, Doppler, and trans-esophageal probes and systems Use of ionizing radiation treatments

Sponsors & Collaborators

• EBR Systems, Inc.: lead

Study Sites (3)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Herzzentrum Brandenburg

Bernau, Germany

Location

Cardiocentro Ticini

Lugano, Switzerland

Location

Related Publications (1)

• Sieniewicz BJ, Betts TR, James S, Turley A, Butter C, Seifert M, Boersma LVA, Riahi S, Neuzil P, Biffi M, Diemberger I, Vergara P, Arnold M, Keane DT, Defaye P, Deharo JC, Chow A, Schilling R, Behar J, Rinaldi CA. Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system. Heart Rhythm. 2020 Aug;17(8):1291-1297. doi: 10.1016/j.hrthm.2020.03.002. Epub 2020 Mar 9.

  PMID: 32165181 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: February 8, 2016
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2024-07

Locations

DE (1); CH (1); DK (1)