BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

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Trial ID: NCT06059638

Purpose

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.

Official Title

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Stanford Investigator(s)

Alexander C. Perino
Alexander C. Perino

Clinical Assistant Professor, Medicine - Cardiovascular Medicine

Eligibility

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

Intervention(s):

device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Hans-Peter Stoll, MD, PhD
646-956-2161