NCT01905670

Brief Summary

The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable heart-failure

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 9, 2020

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

July 19, 2013

Last Update Submit

July 7, 2020

Conditions

Heart FailureVentricular DysfunctionCardiomyopathiesHeart DiseasesCardiovascular Diseases

Keywords

Cardiac Resynchronization Therapycardiac pacingelectrical stimulationbi-ventricular pacing

Outcome Measures

Primary Outcomes (3)

  • Number of patients with device-related adverse events as a measure of safety

    Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.

    24 hour peri-operative and one month

  • Number of patients with procedure-related adverse events as a measure of safety

    Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.

    24 hour perioperative and one month

  • Bi-ventricular pacing capture

    Bi-ventricular pacing capture documented on 12-lead EKG

    one month

Secondary Outcomes (5)

  • Number of patients with device-related adverse events as a measure of safety

    6 months

  • Number of patients with serious adverse events as a measure of safety

    6 months

  • Bi-ventricular pacing capture

    6 months

  • Clinical composite score

    6 months

  • Change in echocardiographic indices

    6 months

Study Arms (1)

Implant

EXPERIMENTAL

Implant of the WiCS-LV system

Device: WiCS-LV system

Interventions

WiCS-LV systemDEVICE

Wireless cardiac stimulator implant to pace the left ventricle for CRT Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator

Also known as: Implant
Implant

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with standard indications for CRT based upon the most recent ESC/EHRA guidelines AND meeting criteria for one of these two categories:
  • Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT but in whom standard CRT is not advisable due to known high risk - referred to as "upgrades". Justifications for not using standard CRT must be documented in a CRF.
  • Patients in whom coronary sinus lead implantation or attempted implantation for CRT has failed to provide demonstrable therapy benefit - referred to as "untreated"

You may not qualify if:

  • Inability to comply with the study follow-up or other study requirements
  • History of chronic alcohol/drug abuse and currently using alcohol/drugs
  • Non-ambulatory (or unstable) NYHA class 4
  • Contraindication to heparin
  • Contraindication to both chronic anticoagulants and antiplatelet agents
  • Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents)
  • Thrombocytopenia (platelet count \<150,000)
  • Contraindication to iodinated contrast agents
  • Intracardiac thrombus by transesophageal echocardiography
  • Age less than 18 years or greater than 75
  • Attempted IPG implant within 3 days
  • Life expectancy of less than 12 months
  • Chronic hemodialysis
  • Stage 4 or 5 renal dysfunction defined as GFR \<30
  • Grade 4 mitral valve regurgitation
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Related Publications (1)

  • Reddy VY, Miller MA, Neuzil P, Sogaard P, Butter C, Seifert M, Delnoy PP, van Erven L, Schalji M, Boersma LVA, Riahi S. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129. doi: 10.1016/j.jacc.2017.02.059.

    PMID: 28449772DERIVED

MeSH Terms

Conditions

Heart FailureVentricular DysfunctionCardiomyopathiesHeart DiseasesCardiovascular Diseases

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 23, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2015

Study Completion

November 1, 2019

Last Updated

July 9, 2020

Record last verified: 2018-02

Locations

DK(1)CZ(1)