- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01117792
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
July 1, 2021 updated by: Boston Scientific Corporation
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure.
The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
San Donato Milanese, Italy, 20097
- Policlínico San Donato
-
-
-
-
-
Amsterdam, Netherlands, 1100 DD
- Academisch Medisch Centrum
-
Groningen, Netherlands, 9713 GZ
- Universitair Medisch Centrum
-
Nieuwegein, Netherlands, 3435 CM
- St. Antonius Ziekenhuis
-
Rotterdam, Netherlands, 3015 GD
- Erasmus Medical Center
-
-
-
-
-
Auckland, New Zealand, 1001
- Auckland City Hospital
-
Christchurch, New Zealand, 8002
- Christchurch Hospital
-
-
-
-
-
Dudley, United Kingdom, DY1 2HQ
- Russells Hall Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Replacement of an existing implanted transvenous ICD system
- Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
- Age is >= 18 years
- Appropriate pre-operative ECG as measured with a specially developed template
Exclusion Criteria:
- Subjects unable or unwilling to provide informed consent
- Any condition which precludes the subject's ability to comply with the study requirements
- Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
- Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
- Patients with a serious medical condition and life expectancy of less than one year.
- Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing
- Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
- Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR <= 29.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: S-ICD System
|
implantable defibrillator system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion of Induced Ventricular Fibrillation
Time Frame: Testing done during the implant procedure
|
The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.
|
Testing done during the implant procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stephen O'Connor, PhD, Hon FRCP, Boston Scientific Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
April 28, 2010
First Submitted That Met QC Criteria
May 4, 2010
First Posted (Estimate)
May 5, 2010
Study Record Updates
Last Update Posted (Actual)
July 2, 2021
Last Update Submitted That Met QC Criteria
July 1, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- DN-01040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ACC/AHA/NASPE Class 1, IIa or IIb Indications
-
Medtronic Cardiac Rhythm and Heart FailureCompletedClass I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National GuidelinesUnited States, Netherlands, Japan, Serbia, Spain, Greece, Canada, India, Denmark, Czechia, South Africa, Malaysia, Austria, United Kingdom, Hungary, China, Australia, France, Italy
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedPrimary Myelofibrosis | Polycythemia Vera | Essential Thrombocythemia | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Chronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedPrimary Myelofibrosis | Polycythemia Vera | Essential Thrombocythemia | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Recurrent Adult Acute Myeloid Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell... and other conditionsUnited States, Italy
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedHIV Infection | Unspecified Childhood Solid Tumor, Protocol Specific | Primary Myelofibrosis | Polycythemia Vera | Essential Thrombocythemia | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Chronic Myelomonocytic Leukemia | Juvenile Myelomonocytic Leukemia | Extranodal... and other conditionsUnited States
Clinical Trials on subcutaneous implantable defibrillator (S-ICD) system
-
Boston Scientific CorporationCompletedVentricular Fibrillation | Ventricular TachycardiaUnited Kingdom
-
Boston Scientific CorporationCompletedVentricular TachyarrhythmiasNew Zealand
-
Nantes University HospitalCompletedBrugada Syndrome | S-ICD System (Implantable Defibrillator)Spain, France, Denmark, Germany, Italy
-
Boston Scientific CorporationCompleted
-
Abbott Medical DevicesUniversity of WashingtonCompletedVentricular Fibrillation | Ventricular Tachycardia | Congestive Heart Failure | Sudden Cardiac Death
-
Guidant CorporationCompletedVentricular FibrillationGermany
-
Rigshospitalet, DenmarkRecruitingCoronary Artery Disease | Ventricular Fibrillation | Acute Myocardial Infarction | Out-Of-Hospital Cardiac Arrest | Ventricular Tachycardia, SustainedDenmark
-
OhioHealthAbbott Medical DevicesWithdrawnVentricular Fibrillation | Ventricular TachycardiaUnited States
-
Rhode Island HospitalUnknownDeath, Sudden, CardiacUnited States
-
Medtronic Bakken Research CenterCompletedVentricular Fibrillation | Tachycardia, VentricularItaly