Sick Sinus Node Syndrome
Conditions
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.
Interventions
DEVICEModel 20105
implant and follow-up of study device
Sponsors
Medtronic BRC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed. | 1 month | All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed. |
Countries
Canada, Netherlands, Singapore, South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Model 20105 Receiving the model 20105 Lead
Model 20105: implant and follow-up of study device | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | not acceptable vascular anatomy | 3 |
Baseline characteristics
| Characteristic | Model 20105 |
|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 11.2 |
| QRS duration | 108.7 msec STANDARD_DEVIATION 17.6 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 13 |
| serious Total, serious adverse events | 3 / 13 |
Outcome results
Primary
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.
Time frame: 1 month
Population: all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 20105 | All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed. | 3 Adverse Events |