SD01 Master Study (Safety and Efficacy Study)

January 21, 2025 updated by: Biotronik SE & Co. KG
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of appropriate sensing and pacing
Time Frame: 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.
at the 3-month follow-up
Serious adverse device effects (SADEs) related to the SD01 lead
Time Frame: until the 3-month follow-up
until the 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pacing threshold between Linoxsmart and SD01
Time Frame: 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.
at the 3-month follow-up
Shift rate of the painless shock impedance measurement
Time Frame: between 3- and 6-month follow-up
between 3- and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Roland Richard Tilz, Prof. Dr. med., University Clinic of Schleswig-Holstein, Lübeck, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 22, 2014

Study Completion (Actual)

September 25, 2024

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimated)

April 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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