SD01 Master Study (Safety and Efficacy Study)

Heart Failure Clinical Trial

Official title:

SD01 Master Study (Safety and Efficacy Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01836497
• Other study ID #: TA103
• Status: Active, not recruiting
• Start date: May 2013
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: March 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• SD01 ICD lead

Locations

Country	Name	City	State
Czechia	St. Ann University Hospital	Brno
France	CHU de Saint-Etienne	Saint-Etienne
France	Hopital Civil Strasbourg	Strasbourg
Germany	Helios Klinik Aue	Aue
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinik Jena	Jena
Germany	University Clinic of Schleswig-Holstein	Lübeck
Germany	Carl-von-Basedow Clinic	Merseburg
Germany	Städtisches Klinikum München Bogenhausen	München
Germany	Klinik Rothenburg	Rothenburg ob der Tauber
Germany	Universitätsklinik Würzburg	Würzburg
Hungary	Semmelweiss University Hospital	Budapest
Hungary	University of Debrecen	Debrecen
Latvia	Bovas P. Stradina KUS Latvian Center of Cardiology	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Hungary,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of appropriate sensing and pacing	The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of the 3-month follow-up.	at the 3-month follow-up
Primary	Serious adverse device effects (SADEs) related to the SD01 lead		until the 3-month follow-up
Secondary	Comparison of pacing threshold between Linoxsmart and SD01	Comparison of the manually measured pacing threshold of the SD01 lead system to the Linox SD lead at 3-month follow-up. The idea is that the pacing threshold will be similar within a suitable range.	at the 3-month follow-up
Secondary	Shift rate of the painless shock impedance measurement		between 3- and 6-month follow-up