Bradycardia, Pacemaker
Conditions
Keywords
Pacemaker, Managed Ventricular Pacing, Ventricular Pacing
Brief summary
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.
Interventions
DEVICEImplantable Pulse Generator
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines * Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form
Exclusion criteria
* Subjects with a mechanical tricuspid valve * Subjects with a life expectancy less than two years * Subjects with a Class III indication for permanent pacing * Subjects with lead integrity problems, unless leads are being replaced
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from adverse device effects | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess right ventricular (lower right chamber of the heart) pacing | — |
| To summarize all adverse events reported in the study | — |
| To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations | — |
| To evaluate the user acceptance of TherapyGuide via questionnaire data | — |
Countries
Austria, Czechia, Germany, Netherlands, Serbia and Montenegro, Sweden
Outcome results
None listed