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BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Orchestra BioMed, Inc · with Medtronic · NCT06059638

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
316
US sites recruiting
16
Study start
December 27, 2023
Record last updated
October 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated; Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Conditions: Hypertension; Hypertension, Systolic; Hypertension, Essential

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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
  • On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
  • Office SBP ≥135 mmHg and \<180 mmHg
  • Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg

Exclusion Criteria

  • LVEF \<50%
  • NYHA Class III-IV
  • History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
  • Myocardial infarction (MI) within 3 months
  • Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
  • Permanent atrial fibrillation
  • Mitral valve regurgitation greater than or equal to grade 3
  • Aortic stenosis with a valve area less than 1.5 cm2
  • Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
  • Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Recruiting US locations

Study contacts (from the official record)

  • Steven J. Evans, MD · 917-670-5933 · sevans@orchestrabiomed.com
  • Angela Stagg · astagg@orchestrabiomed.com
All heart & blood pressure studies in California →
BradycArdia paCemaKer With AV Interval Modulation for Blood… (NCT06059638) | Bored Studies