Overview

This trial is active, not recruiting.

Condition sick sinus node syndrome
Treatment model 20105
Sponsor Medtronic BRC
Start date November 2014
End date July 2016
Trial size 16 participants
Trial identifier NCT02301429, LV DDD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Receiving the model 20105 Lead
model 20105
implant and follow-up of study device

Primary Outcomes

Measure
All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.
time frame: 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Model 20105 Lead Study
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic BRC.