Hypertension Trial, Recruiting NCT06059638 Sponsor: Orchestra BioMed, Inc Condition: Hypertension
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Hypertension Trial, Recruiting

NCT06059638
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a condition requiring a dual-chamber pacemaker, or who are already planning to receive one — specifically a Medtronic Astra/Azure model
  • People who are currently on a stable medication routine to manage high blood pressure, including at least one blood pressure-lowering drug
  • People whose blood pressure reading taken at a clinic is 135 mmHg or higher, but below 180 mmHg (the top/systolic number)
  • People whose average blood pressure measured over a 24-hour monitoring period is 130 mmHg or higher, but below 170 mmHg (the top/systolic number)

Who may not be able to join:

  • People whose heart's pumping strength (ejection fraction) is below 50%
  • People with moderate-to-severe heart failure symptoms, classified as NYHA Class III or IV (confirm with trial site)
  • People who have had a stroke or mini-stroke (TIA) within the past 6 months
  • People who have had a heart attack within the past 3 months
  • People who have undergone a heart, carotid artery, or blood vessel procedure (either by keyhole or open surgery) within the past 3 months
  • People with permanent atrial fibrillation (a long-term irregular heart rhythm)
  • People with significant leaking of the mitral heart valve, graded 3 or higher
  • People with a narrowed aortic heart valve where the opening is smaller than 1.5 cm²
  • People who have previously had, or currently have, a device-based treatment for high blood pressure (such as a kidney nerve procedure or a nerve-stimulation therapy)
  • People who already have another active implanted heart device or nerve stimulator, separate from the Astra/Azure pacemaker being used in this trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: David Kandzari, MD, Piedmont Heart Institute

Phone: 646-956-2161

Australian sites

Lyell McEwin Hospital, Elizabeth Vale, South Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Orchestra BioMed, Inc
Registry
ClinicalTrials.gov
Start date
27 December 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months; Freedom from Unanticipated Serious Adverse Device Effects (USADE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov