Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiac Rhythm and Heart Failure
With
Medtronic
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject provides written informed consent and privacy/protection authorization.
Subjects 65 years of age or older.
OR
Subjects with age \>18 and \< 65 years and one of the following stroke risk factors:
Prior stroke or TIA
Diagnosis of hypertension (HTN)
Diagnosis of Diabetes Mellitus (DM)
Diagnosis of Congestive Heart Failure (CHF)
Subjects who meet the Class I/Class II indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device
OR
Subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe CHF symptoms \[NYHA Class III-IV\] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a QRS duration ≥130 ms)13.
You may not be if
Subjects who are to receive a replacement IPG, ICD or CRT device.
Subjects with chronic (permanent) AT/AF.
Subjects with a history of AV nodal dependent arrhythmias.
Subjects with a terminal illness who are not expected to survive more than 6 months.
Subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization.
Subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial.
Subjects who are or will be inaccessible for follow-up at a qualified study center.
