Hypertension, Hypertension, Essential, Hypertension, Systolic
Conditions
Brief 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.
Detailed description
The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized Phase (1 year), and 3) Unblinded Phase (2 years). Patients scheduled for implantation of an Astra/Azure pacemaker, or those who already have one implanted, who also have hypertension, may be screened for inclusion into this study. Subjects meeting randomization eligibility criteria will have the investigational AVIM Therapy RAMware downloaded into the Astra/Azure pacemaker and be randomized 1:1 to either have AVIM therapy turned ON or turned OFF. All subjects will continue to receive antihypertensive drug therapy.
Interventions
DEVICEMedtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
DEVICEMedtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated
Sponsors
Orchestra BioMed, Inc
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug 3. Office SBP ≥135 mmHg and \<180 mmHg 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
Exclusion criteria
1. LVEF \<50% 2. NYHA Class III-IV 3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months 4. Myocardial infarction (MI) within 3 months 5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months 6. Permanent atrial fibrillation 7. Mitral valve regurgitation greater than or equal to grade 3 8. Aortic stenosis with a valve area less than 1.5 cm2 9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy) 10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months | Baseline and 3 months post randomization | Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization |
| Freedom from Unanticipated Serious Adverse Device Effects (USADE) | 3 months post randomization | Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months. |
Countries
Australia, Belgium, China, Czechia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTSteven J. Evans, MD
CONTACTAngela Stagg
PRINCIPAL_INVESTIGATORDavid Kandzari, MD
Piedmont Heart Institute
PRINCIPAL_INVESTIGATORAndrea Russo, MD
Cooper University
Outcome results
None listed