No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
316 (estimated)
Sponsor
Orchestra BioMed, Inc · Industry
Who this trial is looking for
This trial is looking for people with high blood pressure who need a pacemaker. Participants will try a new treatment that adjusts heart rhythms to help lower blood pressure.
Are You a Good Fit for This Trial?
You may be able to join if
I need or already have a dual-chamber pacemaker.
I take at least one medication for high blood pressure.
My blood pressure in the doctor's office is between 135 and 180 mmHg.
My average 24-hour blood pressure is between 130 and 170 mmHg.
You may not be able to join if
I have a heart function score below 50%.
I have severe heart failure.
I had a stroke or mini-stroke in the past 6 months.
I had a heart attack in the past 3 months.
I had any heart surgery or procedure in the past 3 months.
I have permanent atrial fibrillation.
I have severe mitral valve leakage.
I have aortic stenosis with a small valve area.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 cl…
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 ≥135 mmHg and \<180 mmHg
4. Average 24-Hour aSBP ≥130 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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