RecruitingNot Applicable

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

United States500 participantsStarted 2023-12-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months

Timeframe: Baseline and 3 months post randomization

Freedom from Unanticipated Serious Adverse Device Effects (USADE)

Timeframe: 3 months post randomization

Trial details

NCT IDNCT06059638

SponsorOrchestra BioMed, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Hans-Peter Stoll, MD, PhD

646-956-2161 hpstoll@orchestrabiomed.com

View on ClinicalTrials.gov More Hypertension trials