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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
DeviceAntihypertensive therapy utilizing atrioventricular interval modulation.
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
DeviceAVIM therapy is deactivated
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Time frame
Baseline and 3 months post randomization2
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
Time frame
3 months post randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Orchestra BioMed, Inc
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov