Model 20105 Lead Study

Medtronic BRC4 sites in 4 countries16 target enrollmentNovember 2014

ConditionsSick Sinus Node Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sick Sinus Node Syndrome
Sponsor: Medtronic BRC
Enrollment: 16
Locations: 4
Primary Endpoint: All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic BRC

Responsible Party

Sponsor

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