SD01 Master Study (Safety and Efficacy Study)
NCT01836497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 163
Last updated 2025-01-22
Summary
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
Conditions
- Ventricular Tachycardia
- Ventricular Fibrillation
- Heart Failure
Interventions
- DEVICE
-
SD01 ICD lead
Sponsors & Collaborators
-
Biotronik SE & Co. KG
lead INDUSTRY
Principal Investigators
-
Roland Richard Tilz, Prof. Dr. med. · University Clinic of Schleswig-Holstein, Lübeck, Germany
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2014-12-22
- Completion
- 2024-09-25
Countries
- Czechia
- France
- Germany
- Hungary
- Latvia
Study Locations
More Related Trials
-
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
NCT00853645 ·Status: COMPLETED ·Phase: NA
-
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
NCT00399217 ·Status: COMPLETED
-
S-ICD® System Post Approval Study
NCT01736618 ·Status: COMPLETED
-
Identifying Electrocardiographic Markers to Determine Eligibility for the Implantation of a Subcutaneous Defibrillator.
NCT07157449 ·Status: NOT_YET_RECRUITING
-
Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
NCT00273195 ·Status: COMPLETED ·Phase: NA
-
A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers
NCT01454817 ·Status: COMPLETED ·Phase: NA
-
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
NCT03374891 ·Status: COMPLETED ·Phase: NA
-
S-ICD Electrode Registry
NCT05713708 ·Status: NOT_YET_RECRUITING
-
The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs
NCT01665131 ·Status: UNKNOWN ·Phase: NA
-
Supraventricular Tachycardia Collection Study
NCT02158728 ·Status: COMPLETED
-
Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
NCT04127643 ·Status: UNKNOWN
-
A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing
NCT03495297 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
SecuraTM ICD Clinical Evaluation Study
NCT00526227 ·Status: COMPLETED ·Phase: NA
-
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
NCT06604169 ·Status: ACTIVE_NOT_RECRUITING
-
SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
NCT00170287 ·Status: COMPLETED ·Phase: PHASE4
-
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
NCT03846297 ·Status: RECRUITING
-
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
NCT04011631 ·Status: COMPLETED ·Phase: NA
-
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
NCT01963286 ·Status: COMPLETED ·Phase: NA
-
Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy
NCT04014946 ·Status: COMPLETED ·Phase: NA
-
Clinical and Device Functional Assessment of Real World ICD Patients
NCT02341768 ·Status: COMPLETED
-
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
NCT01085435 ·Status: COMPLETED
-
INSIGHTS ICD Registry
NCT00279968 ·Status: COMPLETED
-
Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
NCT01876173 ·Status: COMPLETED ·Phase: NA
-
T-ICD vs S-ICD Shocks: Myocardial Injuries
NCT03458065 ·Status: UNKNOWN
-
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
NCT01161589 ·Status: COMPLETED