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Model 20105 Lead 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: NCT02301429
Recruitment Status : Terminated (Low implant success rate(46%). For the successfull implants, 3month FU and available electrical data showed an increase in threshold values for the left atrium)
First Posted : November 25, 2014
Results First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

Brief Summary:
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.

Condition or disease Intervention/treatment Phase
Sick Sinus Node Syndrome Device: Model 20105 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Model 20105 Lead Study
Study Start Date : November 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Model 20105
Receiving the model 20105 Lead
Device: Model 20105
implant and follow-up of study device




Primary Outcome Measures :
  1. All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed. [ Time Frame: 1 month ]
    All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)
  • Subject has signed and dated the study-specific informed consent form
  • Subject is 18 years of age or older
  • Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study

Exclusion Criteria:

  • Subject is indicated for BiV pacemaker or ICD
  • Subject is pacing dependent
  • Subject has a previous Pacemaker System
  • Subject has known coronary venous vasculature that is inadequate for lead placement
  • Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
  • Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
  • Subject is not in sinus rhythm at implant
  • Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)
  • Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
  • Subject is contraindicated for <1mg dexamethasone acetate
  • Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study
  • Subject has a terminal illness and is not expected to survive more than 6 months
  • Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.
  • Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
  • Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study
  • Subject meets exclusion criteria required by local law.
  • Subject is unable to tolerate an urgent thoracotomy

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 ClinicalTrials.gov identifier (NCT number): NCT02301429


Locations
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Canada
London Teaching Hospital
London, Canada
Netherlands
Reinier de Graaf Hospital
Delft, Netherlands
Singapore
NUHCS, National University Hospital
Singapore, Singapore
South Africa
Milpark hospital
Johannesburg, South Africa
Sponsors and Collaborators
Medtronic BRC

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Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT02301429     History of Changes
Other Study ID Numbers: LV DDD
First Posted: November 25, 2014    Key Record Dates
Results First Posted: October 26, 2016
Last Update Posted: October 26, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Cardiac Conduction System Disease
Pathologic Processes