Clinical trial NCT01294527: Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
Official title: Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Ventricular Dysfunction
Cardiomyopathy
Keywords: Cardiac Resynchronization Therapy
cardiac pacing
electrical stimulation
bi-ventricular pacing
Lead sponsor: EBR Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with device-related adverse events as a measure of safety
timeFrame: 24 hour peri-operative and one month
measure: Number of patients with procedure-related adverse events as a measure of safety
timeFrame: 24 hour perioperative and one month
measure: Bi-ventricular pacing capture
timeFrame: one month
Secondary outcomes:
measure: Number of patients with device-related adverse events as a measure of safety
timeFrame: 6 months
measure: Number of patients with serious adverse events as a measure of safety
timeFrame: 6 months
measure: Left ventricular pacing capture
timeFrame: 1, 3, and 6 months
measure: Bi-ventricular pacing capture
timeFrame: 3 and 6 months
measure: Bi-ventricular pacing capture
timeFrame: 1, 3, and 6 months
measure: Clinical composite score
timeFrame: 6 months
measure: Change in echocardiographic indices
timeFrame: 6 months
measure: Change in blood laboratory Brain Natriuretic Peptide
timeFrame: 6 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nouvelles Clinicques Nantaises
city: Rennes
country: France
facility: Hospital Pontchaillou-CHU
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bernau
country: Germany
facility: Herzzentrum Brandenburg
city: Coburg
country: Germany
facility: Klinium Coburg gGmbH
city: Dresden
country: Germany
facility: Facharztzentrum Dresden-Neustadt GbR
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Zwolle
country: Netherlands
facility: Isala Klinieken Zwolle
city: Lugano
country: Switzerland
facility: Cardiocentro Ticini
Study officials:
affiliation: Fondazione Cardiocentro, Lugano CH
name: Angelo Auricchio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Auricchio A, Delnoy PP, Butter C, Brachmann J, Van Erven L, Spitzer S, Moccetti T, Seifert M, Markou T, Laszo K, Regoli F; Collaborative Study Group. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study. Europace. 2014 May;16(5):681-8. doi: 10.1093/europace/eut435. Epub 2014 Feb 4.
citation: Auricchio A, Delnoy PP, Regoli F, Seifert M, Markou T, Butter C; collaborative study group. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace. 2013 Aug;15(8):1191-7. doi: 10.1093/europace/eut124. Epub 2013 May 23.