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 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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