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

Orchestra Biomed

Status: Enrolling

Conditions: Hypertension; Hypertension, Essential; 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 dual-chamber Medtronic Astra/Azure pacemaker.

Full 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 who are scheduled to undergo implantation of a, or already have an implanted, de novo Astra/Azure pacemaker system, who also have uncontrolled hypertension may be screened for inclusion into this study. All eligible subjects will receive the AVIM RAMware and be randomized 1:1 to either have AVIM therapy turned On or turned Off. All subjects will continue to receive antihypertensive drug therapy.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has or is indicated for a de novo dual chamber pacemaker. Patient informed consent must be obtained within 30 days prior to a planned de novo implant of a Medtronic Astra/Azure dual chamber pacemaker system or up to 365 days after
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 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

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