Status:
RECRUITING
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Lead Sponsor:
Orchestra BioMed, Inc
Collaborating Sponsors:
Medtronic
Conditions:
Hypertension
Hypertension, Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-c...
Detailed Description
The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized Phase (1 year), and 3) Unblinded Phase (2 years). Patients scheduled for implantation of an Astra/Azure pace...
Eligibility Criteria
Inclusion
- 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
Exclusion
- LVEF \<50%
- NYHA Class III-IV
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
- Myocardial infarction (MI) within 3 months
- Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
- Permanent atrial fibrillation
- Mitral valve regurgitation greater than or equal to grade 3
- Aortic stenosis with a valve area less than 1.5 cm2
- Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
- Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06059638
Start Date
December 27 2023
End Date
August 1 2029
Last Update
December 11 2025
Active Locations (94)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
Adventist Health Glendale
Glendale, California, United States, 91206
3
Stanford
Redwood City, California, United States, 94063
4
Scripps Clinic
San Diego, California, United States, 92121