SD01 Registry (SD01 ICD Lead) (SD01 Registry)

January 22, 2024 updated by: Biotronik SE & Co. KG
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

280

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

  • Germany
      • Berlin, Germany
        • DRK Klinikum Berlin-Köpenick
      • Berlin, Germany
        • Vivantes Humboldt Klinikum Berlin
      • Hamburg, Germany
        • Universitares Herzzentrum Hamburg
      • Leverkusen, Germany
        • Klinikum Leverkusen
      • Lübeck, Germany, 23538
        • University Clinic of Schleswig-Holstein
      • Merseburg, Germany
        • Carl-von-Basedow Klinik
      • Papenburg, Germany
        • Marienkrankenhaus Papenburg
      • Ratzeburg, Germany
        • DRK Krankenhaus Moelln-Ratzeburg
      • Suhl, Germany
        • SRH Zentralklinikum Suhl
      • Würzburg, Germany
        • Universitätsklinik Würzburg

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:

  • Meet a standard indication for ICD/CRT-D therapy
  • First ICD/CRT-D implantation or upgrade from pacemaker
  • Signed informed consent form
  • Willing to participate for the whole duration of the registry
  • Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger
  • Patient has legal capacity and ability to consent

Exclusion Criteria:

  • Meet a standard contraindication for an ICD/CRT-D therapy
  • Age <18 years
  • Pregnant or breast-feeding women
  • Cardiac surgery planned within the next six months
  • 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SD01 ICD lead
Device: SD01 ICD lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SADE-free rate
Time Frame: 10 years
10 years

Other Outcome Measures

Outcome Measure
Time Frame
Pacing threshold of SD01
Time Frame: 3-month follow-up
3-month follow-up
Sensing amplitude of SD01
Time Frame: 3-month follow-up
3-month follow-up
Device deficiencies
Time Frame: 10 years
10 years
Long-term pacing impedance, pacing threshold, sensing amplitude and painless shock impedance of SD01 and other leads, if applicable
Time Frame: 10 years
10 years
Analysis of arrhythmias and their treatment
Time Frame: until 3-month follow-up
until 3-month follow-up
ICD/CRT-D system performance
Time Frame: 10 years
10 years
SD01 implantation information, handling and operation time record
Time Frame: Implantation
Implantation

Collaborators and Investigators

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

Sponsor

Biotronik SE & Co. KG

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

March 1, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimated)

December 18, 2013

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67 (TA108)

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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