Model 20105 Lead Study

September 2, 2016 updated by: Medtronic BRC
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • London, Canada
        • London Teaching Hospital
  • Netherlands
      • Delft, Netherlands
        • Reinier de Graaf Hospital
  • Singapore
      • Singapore, Singapore
        • NUHCS, National University Hospital
  • South Africa
      • Johannesburg, South Africa
        • Milpark Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic BRC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LV DDD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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