Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— WiSE-CRT  

Official title:

Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294527
• Other study ID #: EBR-00980
• Status: Completed
• Phase: N/A
• First received: February 8, 2011
• Last updated: February 6, 2017
• Start date: February 2011
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: EBR Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.

Description:

Eligible patients will undergo an acoustic window assessment using transthoracic echocardiography. Patients with adequate acoustic windows will undergo implantation of the WiCS-LV system.

Patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6 months post implantation. Extended follow-up will be obtained via a registry at 1, 2, 3, 4, and 5 years post implantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2016
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:

1. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"

2. Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"

3. Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as "non-responders"

Exclusion Criteria:

1. Inability to comply with the study follow-up or other study requirements

2. Contraindication to heparin

3. Contraindication to both chronic anticoagulants and antiplatelet agents

4. Contraindication to iodinated contrast agents

5. Intracardiac thrombus by transesophageal echocardiography

6. Age less than 18 years

7. Attempted IPG implant within 3 days

8. Life expectancy of < 12 months

9. Chronic hemodialysis

10. Myocardial infarction within one month

11. Major cardiac surgery within one month

12. Female of childbearing potential, pregnant, or breastfeeding

13. Noncardiac implanted electrical stimulation therapy devices

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure
• Ventricular Dysfunction

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	Nouvelles Clinicques Nantaises	Nantes
France	Hospital Pontchaillou-CHU	Rennes
Germany	Kerckhoff-Klinik	Bad Nauheim
Germany	Herzzentrum Brandenburg	Bernau
Germany	Klinium Coburg gGmbH	Coburg
Germany	Facharztzentrum Dresden-Neustadt GbR	Dresden
Germany	Herzzentrum Leipzig GmbH	Leipzig
Netherlands	Leiden University Medical Centre	Leiden
Netherlands	Isala Klinieken Zwolle	Zwolle
Switzerland	Cardiocentro Ticini	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
EBR Systems, Inc.

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Bi-ventricular pacing capture	Bi-ventricular pacing capture documented on 12-lead EKG	one month
Secondary	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.	6 months
Secondary	Number of patients with serious adverse events as a measure of safety		6 months
Secondary	Left ventricular pacing capture	Left ventricular pacing capture documented on 12-lead EKG	1, 3, and 6 months
Secondary	Bi-ventricular pacing capture	Bi-ventricular pacing capture documented on 12-lead EKG	3 and 6 months
Secondary	Bi-ventricular pacing capture	Bi-ventricular pacing capture on 24 hour ambulatory monitoring	1, 3, and 6 months
Secondary	Clinical composite score	Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment	6 months
Secondary	Change in echocardiographic indices	change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction	6 months
Secondary	Change in blood laboratory Brain Natriuretic Peptide	change in NT-proBNP level	6 months