BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Key facts
- Where
- Bologna, Rome, and Verona, ItalySee the 4 sites
Where in Italy
- Policlinico Di Sant Orsola MalpighiBologna, ItalyNo longer taking part
- Campus Bio-Medico University HospitalRome, ItalyTaking people
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people
- IRCCS Sacro Cuore Don CalabriaVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Orchestra BioMed, Inc
- Trial code
- NCT06059638
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months; Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy); History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months; Myocardial infarction (MI) within 3 months; Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant; LVEF <50%; NYHA Class III-IV; Permanent atrial fibrillation; Mitral valve regurgitation greater than or equal to grade 3; Aortic stenosis with a valve area less than 1.5 cm2.