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Model 20105 Lead Study

Primary Purpose

Sick Sinus Node Syndrome

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Model 20105
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sick Sinus Node Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Teaching Hospital
  • Reinier de Graaf Hospital
  • NUHCS, National University Hospital
  • Milpark hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Model 20105

Arm Description

Receiving the model 20105 Lead

Outcomes

Primary Outcome Measures

All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2014
Last Updated
September 2, 2016
Sponsor
Medtronic BRC
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1. Study Identification

Unique Protocol Identification Number
NCT02301429
Brief Title
Model 20105 Lead Study
Official Title
Model 20105 Lead Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
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
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Node Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Model 20105
Arm Type
Experimental
Arm Description
Receiving the model 20105 Lead
Intervention Type
Device
Intervention Name(s)
Model 20105
Intervention Description
implant and follow-up of study device
Primary Outcome Measure Information:
Title
All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
Description
All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
London Teaching Hospital
City
London
Country
Canada
Facility Name
Reinier de Graaf Hospital
City
Delft
Country
Netherlands
Facility Name
NUHCS, National University Hospital
City
Singapore
Country
Singapore
Facility Name
Milpark hospital
City
Johannesburg
Country
South Africa

12. IPD Sharing Statement

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Model 20105 Lead Study

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