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

Tracking Information
First Submitted Date April 12, 2013
First Posted Date April 22, 2013
Last Update Posted Date April 15, 2020
Study Start Date May 2013
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2013)
  • 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.
  • Serious adverse device effects (SADEs) related to the SD01 lead [ Time Frame: until the 3-month follow-up ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 17, 2013)
  • 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.
  • Shift rate of the painless shock impedance measurement [ Time Frame: between 3- and 6-month follow-up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SD01 Master Study (Safety and Efficacy Study)
Official Title SD01 Master Study (Safety and Efficacy Study)
Brief Summary The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication
Condition
  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Heart Failure
Intervention Device: SD01 ICD lead
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 30, 2018)
163
Original Estimated Enrollment
 (submitted: April 17, 2013)
160
Estimated Study Completion Date March 2025
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czechia,   France,   Germany,   Hungary,   Latvia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT01836497
Other Study ID Numbers TA103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biotronik SE & Co. KG
Study Sponsor Biotronik SE & Co. KG
Collaborators Not Provided
Investigators
Principal Investigator: Roland Richard Tilz, Prof. Dr. med. University Clinic of Schleswig-Holstein, Lübeck, Germany
PRS Account Biotronik SE & Co. KG
Verification Date October 2019