SD01 Master Study (Safety and Efficacy Study)

NCT01836497 | Completed

• 1 other identifier: TA103
• Study Type: observational
• Target: 163
• Locations: 5 countries
• Sites: 14

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

• Serious adverse device effects (SADEs) related to the SD01 lead

  until the 3-month follow-up

Secondary Outcomes (2)

• Comparison of pacing threshold between Linoxsmart and SD01

  at the 3-month follow-up

• Shift rate of the painless shock impedance measurement

  between 3- and 6-month follow-up

Interventions

SD01 ICD lead DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (14)

St. Ann University Hospital

Brno, Czechia

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

Hopital Civil Strasbourg

Strasbourg, France

Location

Helios Klinik Aue

Aue, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinik Jena

Jena, Germany

Location

University Clinic of Schleswig-Holstein

Lübeck, Germany

Location

Carl-von-Basedow Clinic

Merseburg, Germany

Location

Städtisches Klinikum München Bogenhausen

München, Germany

Location

Klinik Rothenburg

Rothenburg upon Tauber, Germany

Location

Universitätsklinik Würzburg

Würzburg, Germany

Location

Semmelweiss University Hospital

Budapest, Hungary

Location

University of Debrecen

Debrecen, Hungary

Location

Bovas P. Stradina KUS Latvian Center of Cardiology

Riga, Latvia

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland Richard Tilz, Prof. Dr. med.

  University Clinic of Schleswig-Holstein, Lübeck, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 22, 2013
• Study Start: May 1, 2013
• Primary Completion: December 22, 2014
• Study Completion: September 25, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-07

Locations

LA (1); FR (2); CZ (1); DE (8); HU (2)