BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
← catalyst calendarNCT06059638 · readout ≤ 134 d
Sponsored by Orchestra BioMed, Inc (industry) · OBIO — their whole pipeline →. With Medtronic.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
500estimated
Sites
131
Countries
Australia, Belgium, China +12
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-27 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2023-09-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hypertension
- Hypertension, Systolic
- Hypertension, Essential
Interventions
- Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated — also filed as BackBeat CNT
- Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Primary outcomes
what the primary-completion date above is the date OFChange from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
measured Baseline and 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
measured 3 months post randomization
Publications
- PMID 34387126 — cited as background
- PMID 29275370 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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