BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Launched by ORCHESTRA BIOMED, INC · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is examining a new approach to help manage high blood pressure (hypertension) using a special feature in a heart device called a pacemaker. The study is looking to see if this feature, known as atrioventricular interval modulation (AVIM), can make the pacemaker more effective for people who already have one implanted. The trial is open to people aged 65 to 74 who have recently received a Medtronic Astra/Azure dual-chamber pacemaker and are taking medication for their high blood pressure. To qualify, participants should have specific blood pressure readings and be stable on their current treatment.

If you decide to join this study, you will be part of a randomized group, meaning you might receive the new AVIM feature or standard care without knowing which one you’ve been assigned. The trial is currently recruiting participants, and it’s important to know that there are certain health conditions that could exclude you from participating, such as specific heart issues or recent medical events like a heart attack. Overall, this trial aims to find new ways to improve blood pressure management for patients using advanced pacemaker technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient has or is indicated for a de novo dual chamber pacemaker. Patient informed consent must be obtained within 30 days prior to a planned de novo implant of a Medtronic Astra/Azure dual chamber pacemaker system or up to 365 days after
• • 2. On a stable antihypertension treatment regimen with 1, 2, or 3 classes of antihypertensive drugs
• • 3. Office SBP ≥140 mmHg and \<180 mmHg
• • 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
• Exclusion Criteria:
• • 1. LVEF \<50%
• • 2. NYHA Class II-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. Persistent or permanent atrial fibrillation
• • 7. Mitral valve regurgitation greater than 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