BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
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 previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG.
Conditions
- Hypertension
- Hypertension, Systolic
- Hypertension,Essential
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Within 90 days of a de novo implant of a Medtronic Astra/Azure dual chamber pacemaker and Medtronic pacing leads 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
- 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 2+ 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Group |
AVIM therapy activated with continued stable antihypertensive drug therapy |
|
|
Sham Comparator Control Group |
AVIM therapy deactivated with continued stable antihypertensive drug therapy |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- Orchestra BioMed, Inc
Detailed Description
The study will be conducted in three phases: 1) Screening/ Run-in Phase, 2) Double-blind Randomized phase (1 year), and 3) Randomized unblinded phase (2 years). Patients within 90 days of de novo implant of a Medtronic Astra/Azure pacemaker also having uncontrolled hypertension may be approached for inclusion into this study. During the Double-blind Randomized Phase, subjects in the control group will receive standard-of-care pacemaker and hypertension therapy.