RecruitingHypertensionHypertension, SystolicHypertension, Essential

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Eligible age

18+ yrs

Accepts

All genders

Locations

29 states

Healthy volunteers

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About this study

A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.

Sponsor: Orchestra BioMed, Inc

You may qualify if…

✓ 1. 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
✓ 2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
✓ 3. Office SBP ≥135 mmHg and \<180 mmHg
✓ 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg

You may not qualify if…

✕ 1. LVEF \<50%
✕ 2. NYHA Class III-IV
✕ 3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
✕ 4. Myocardial infarction (MI) within 3 months
✕ 5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
✕ 6. Permanent atrial fibrillation
✕ 7. Mitral valve regurgitation greater than or equal to grade 3
✕ 8. Aortic stenosis with a valve area less than 1.5 cm2