SD01 Master Study (Safety and Efficacy Study)

Completed

• Conditions: Ventricular Fibrillation; Heart Failure; Ventricular Tachycardia

• Registration Number: NCT01836497
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Study Start: 2013-05
• Primary Completion: 2014-12-22
• Status Verified: 2024-07
• Study Completion: 2024-09-25
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of appropriate sensing and pacing	at the 3-month follow-up	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.
Serious adverse device effects (SADEs) related to the SD01 lead	until the 3-month follow-up

Secondary Outcome Measures

Name	Time	Method
Comparison of pacing threshold between Linoxsmart and SD01	at the 3-month follow-up	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.
Shift rate of the painless shock impedance measurement	between 3- and 6-month follow-up

Trial Locations

Locations (14)

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France

St. Ann University Hospital; 🇨🇿 Brno, Czechia

Hopital Civil Strasbourg; 🇫🇷 Strasbourg, France

Helios Klinik Aue; 🇩🇪 Aue, Germany

Universitätsklinik Jena; 🇩🇪 Jena, Germany

University Clinic of Schleswig-Holstein; 🇩🇪 Lübeck, Germany

Klinik Rothenburg; 🇩🇪 Rothenburg ob der Tauber, Germany

Städtisches Klinikum München Bogenhausen; 🇩🇪 München, Germany

Semmelweiss University Hospital; 🇭🇺 Budapest, Hungary

Universitätsklinik Würzburg; 🇩🇪 Würzburg, Germany

University of Debrecen; 🇭🇺 Debrecen, Hungary

Bovas P. Stradina KUS Latvian Center of Cardiology; 🇱🇻 Riga, Latvia

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Carl-von-Basedow Clinic; 🇩🇪 Merseburg, Germany