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โ† Trials
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BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

RecruitingNAAges 18 Years - anyAllOrchestra BioMed, Inc
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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 โ‰ฅ135 mmHg and \<180 mmHg 4. Average 24-Hour aSBP โ‰ฅ130 mmHg and \<170 mmHg Exclusion Criteria: 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 9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy) 10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
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What it tests

  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
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Where

131 sites
HonorHealth
Scottsdale, United States
Adventist Health Glendale
Glendale, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Stanford
Redwood City, United States
Scripps Clinic
San Diego, United States
Sutter Valley Hospitals
San Francisco, United States
South Denver Cardiology
Denver, United States
Colorado Heart and Vascular
Golden, United States

โ€ฆand 123 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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