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
All study objectives are being assessed during the intraoperative baroreceptor stimulation. No subsequent testing will be performed. The follow-up visit is only intended to assess for adverse events.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is at least 18 years old
Subject is hypertensive (defined as at least one in-office Systolic BP measurement ≥140 mm Hg or Diastolic BP ≥90 mm Hg within three months prior to enrollment
Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures.
Subject (or subject's legally authorized representative) is able and wiling to give informed consent
You may not be if
Subject has an ejection fraction (EF) less than 35% (by most recent echocardiography in the past 6 months) and there has been no change in clinical status relative to EF
Subject is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
Subject is enrolled or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the Medtronic study manager, documenting that there is not a concern that co-enrollment could confound the results of this trial.
Subject is unable or unwilling to participate with study procedures
