NCT06059638 BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
| NCT ID | NCT06059638 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Orchestra BioMed, Inc |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2023-12-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 316 participants in total. It began in 2023-12-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-chamber Medtronic Astra/Azure pacemaker.
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 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
Contact & Investigator
David Kandzari, MD
PRINCIPAL INVESTIGATOR
Piedmont Heart Institute
Frequently Asked Questions
Who can join the NCT06059638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06059638 currently recruiting?
Yes, NCT06059638 is actively recruiting participants. Contact the research team at sevans@orchestrabiomed.com for enrollment information.
Where is the NCT06059638 trial being conducted?
This trial is being conducted at Scottsdale, United States, Glendale, United States, Newport Beach, United States, Redwood City, United States and 11 additional locations.
Who is sponsoring the NCT06059638 clinical trial?
NCT06059638 is sponsored by Orchestra BioMed, Inc. The principal investigator is David Kandzari, MD at Piedmont Heart Institute. The trial plans to enroll 316 participants.