BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT (BACKBEAT)

Orchestra Biomed

Status: Enrolling

Conditions: Hypertension,Essential; Hypertension; Hypertension, Systolic

Treatments: Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated; Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Study type: Interventional

Funder types: Industry

Identifiers

NCT06059638

CS-08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Within 90 days of a de novo implant of a Medtronic Astra/Azure dual chamber pacemaker and Medtronic pacing leads
2. On a stable antihypertension treatment regimen with 1, 2 or 3 classes of antihypertensive drugs
3. Office SBP ≥140 mmHg and <180 mmHg
4. Average 24-Hour aSBP ≥130 mmHg and <170 mmHg

Exclusion criteria

1. LVEF <50%
2. NYHA Class II-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. Persistent or permanent atrial fibrillation
7. Mitral valve regurgitation greater than 2+
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 2 patient groups

Treatment Group

Experimental group

Description:

AVIM therapy activated with continued stable antihypertensive drug therapy

Treatment:

Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Control Group

Sham Comparator group

Description:

AVIM therapy deactivated with continued stable antihypertensive drug therapy

Treatment:

Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated