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SD01 Registry (SD01 ICD Lead) (SD01 Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02014675
Recruitment Status : Active, not recruiting
First Posted : December 18, 2013
Last Update Posted : October 17, 2018
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief Summary:
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.

Condition or disease Intervention/treatment
Ventricular Fibrillation Ventricular Tachycardia Heart Failure Device: SD01 ICD lead

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 280 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: SD01 Registry (SD01 ICD Lead)
Study Start Date : March 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : April 2025

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

Primary Outcome Measures :
  1. SADE-free rate [ Time Frame: 10 years ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02014675

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DRK Klinikum Berlin-Köpenick
Berlin, Germany
Vivantes Humboldt Klinikum Berlin
Berlin, Germany
Universitäres Herzzentrum Hamburg
Hamburg, Germany
Klinikum Leverkusen
Leverkusen, Germany
University Clinic of Schleswig-Holstein
Lübeck, Germany, 23538
Carl-von-Basedow Klinik
Merseburg, Germany
Marienkrankenhaus Papenburg
Papenburg, Germany
DRK Krankenhaus Moelln-Ratzeburg
Ratzeburg, Germany
SRH Zentralklinikum Suhl
Suhl, Germany
Universitätsklinik Würzburg
Würzburg, Germany
Sponsors and Collaborators
Biotronik SE & Co. KG

Additional Information:

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Responsible Party: Biotronik SE & Co. KG Identifier: NCT02014675     History of Changes
Other Study ID Numbers: 67 (TA108)
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: May 2018

Keywords provided by Biotronik SE & Co. KG:

Additional relevant MeSH terms:
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Heart Failure
Tachycardia, Ventricular
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes