BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Study Overview
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Brief Summary
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A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG.

Detailed Description
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The study will be conducted in three phases: 1) Screening/ Run-in Phase, 2) Double-blind Randomized phase (1 year), and 3) Randomized unblinded phase (2 years). Patients within 90 days of de novo implant of a Medtronic Astra/Azure pacemaker also having uncontrolled hypertension may be approached for inclusion into this study. During the Double-blind Randomized Phase, subjects in the control group will receive standard-of-care pacemaker and hypertension therapy.

Official Title
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BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Conditions
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Hypertension, Hypertension, Systolic, Hypertension,Essential

Intervention / Treatment
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* Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
* Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within 90 days of a de novo implant of a Medtronic Astra/Azure dual chamber pacemaker and Medtronic pacing leads On a stable antihypertension treatment regimen with 1, 2 or 3 classes of antihypertensive drugs Office SBP ≥140 mmHg and <180 mmHg Average 24-Hour aSBP ≥130 mmHg and <170 mmHg Exclusion Criteria: LVEF <50% NYHA Class II-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 Persistent or permanent atrial fibrillation Mitral valve regurgitation greater than 2+ Aortic stenosis with a valve area less than 1.5 cm2 Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy) Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>AVIM therapy activated with continued stable antihypertensive drug therapy | Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated<br>* Antihypertensive therapy utilizing atrioventricular interval modulation.<br>* Other names: BackBeat CNT;|
| Sham Comparator: Control Group<br>AVIM therapy deactivated with continued stable antihypertensive drug therapy | Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated<br>* AVIM therapy is deactivated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 3 months post randomization | 
| Freedom from Unanticipated Serious Adverse Device Effects (USADE) | Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months. | 3 months post randomization |