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SD01 Master Study (Safety and Efficacy Study)

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: NCT01836497
Recruitment Status : Active, not recruiting
First Posted : April 22, 2013
Last Update Posted : April 15, 2020
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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

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

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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SD01 Master Study (Safety and Efficacy Study)
Study Start Date : May 2013
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : March 2025

Primary Outcome Measures :
  1. 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.

  2. Serious adverse device effects (SADEs) related to the SD01 lead [ Time Frame: until the 3-month follow-up ]

Secondary Outcome Measures :
  1. 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.

  2. Shift rate of the painless shock impedance measurement [ Time Frame: between 3- and 6-month follow-up ]

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:

  • 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

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): NCT01836497

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St. Ann University Hospital
Brno, Czechia
CHU de Saint-Etienne
Saint-Etienne, France
Hopital Civil Strasbourg
Strasbourg, France
Helios Klinik Aue
Aue, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinik Jena
Jena, Germany
University Clinic of Schleswig-Holstein
Lübeck, Germany
Carl-von-Basedow Clinic
Merseburg, Germany
Städtisches Klinikum München Bogenhausen
München, Germany
Klinik Rothenburg
Rothenburg ob der Tauber, Germany
Universitätsklinik Würzburg
Würzburg, Germany
Semmelweiss University Hospital
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Bovas P. Stradina KUS Latvian Center of Cardiology
Riga, Latvia
Sponsors and Collaborators
Biotronik SE & Co. KG
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Principal Investigator: Roland Richard Tilz, Prof. Dr. med. University Clinic of Schleswig-Holstein, Lübeck, Germany
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Responsible Party: Biotronik SE & Co. KG Identifier: NCT01836497    
Other Study ID Numbers: TA103
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: October 2019
Additional relevant MeSH terms:
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Tachycardia, Ventricular
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes