BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Prior treatment

• Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
• Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)

Other illness

• History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
• Myocardial infarction (MI) within 3 months
• Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Lab values

• LVEF \<50%

Other

• NYHA Class III-IV
• Permanent atrial fibrillation
• Mitral valve regurgitation greater than or equal to grade 3
• Aortic stenosis with a valve area less than 1.5 cm2

• Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamber pacemaker system or at any time thereafter
• On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
• Office SBP ≥135 mmHg and \<180 mmHg
• Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg