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The trial is taking place at:
W

West Houston Area Clinical Trial Consultants | Wichita, KS

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

O

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

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

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

Trial contacts and locations

22

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Central trial contact

Hans-Peter Stoll, MD, PhD; Angela Stagg

Data sourced from clinicaltrials.gov

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