Clinical trial NCT01836497: SD01 Master Study (Safety and Efficacy Study)
Official title: SD01 Master Study (Safety and Efficacy Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Heart Failure
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-04-22
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication

Brief summary: The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.


Eligibility criteria: Inclusion Criteria:

* Standard indication for an ICD/CRT-D therapy
* Signed informed consent form
* Patient is willing and able to participate for the whole study duration
* Patient is willing and able to activate and use the CardioMessenger
* Legal capacity and ability to consent.

Exclusion Criteria:

* Standard contraindication for an ICD/CRT-D therapy
* Age \<18 years.
* Pregnant or breastfeeding
* Cardiac surgery is planned within the next six months
* Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
* Enrollment in another cardiac clinical investigation with active treatment arm
* Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
* Dexamethasone acetate intolerance

Primary outcomes:
measure: Rate of appropriate sensing and pacing
timeFrame: at the 3-month follow-up
measure: Serious adverse device effects (SADEs) related to the SD01 lead
timeFrame: until the 3-month follow-up
Secondary outcomes:
measure: Comparison of pacing threshold between Linoxsmart and SD01
timeFrame: at the 3-month follow-up
measure: Shift rate of the painless shock impedance measurement
timeFrame: between 3- and 6-month follow-up
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: St. Ann University Hospital
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: Hopital Civil Strasbourg
city: Aue
country: Germany
facility: Helios Klinik Aue
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Jena
country: Germany
facility: Universitätsklinik Jena
city: Lübeck
country: Germany
facility: University Clinic of Schleswig-Holstein
city: Merseburg
country: Germany
facility: Carl-von-Basedow Clinic
city: München
country: Germany
facility: Städtisches Klinikum München Bogenhausen
city: Rothenburg ob der Tauber
country: Germany
facility: Klinik Rothenburg
city: Würzburg
country: Germany
facility: Universitätsklinik Würzburg
city: Budapest
country: Hungary
facility: Semmelweiss University Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Riga
country: Latvia
facility: Bovas P. Stradina KUS Latvian Center of Cardiology
Study officials:
affiliation: University Clinic of Schleswig-Holstein, Lübeck, Germany
name: Roland Richard Tilz, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: