Study for people with Hypertension

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 12 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor Orchestra BioMed, Inc
Registry number NCT06059638
Started 27 December 2023 Today 16 October 2026 Estimated completion 1 December 2026

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Lyell McEwin Hospital Elizabeth Vale SA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 12 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 316

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 27 December 2023
Estimated completion 1 December 2026
Registry last updated 2 October 2026
Checked by Voxsanity 12 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 2 October 2026.
  • This page last checked by Voxsanity: 12 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.