BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrchestra BioMed, Inc
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Treatment groups
500 Participants
are divided into 2 treatment groupsLocations
129Australia
Lyell McEwin Hospital5112, Elizabeth ValeSouth Australia, Australia
Alfred Health Hospital3004, MelbourneVictoria, Australia
Belgium
OLV Ziekenhuis Aalst Belgium
Middelheim Ziekenhuis Antwerp Belgium
Sponsors and collaborators
Orchestra BioMed, Inc
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov