BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Purpose

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.

Conditions

  • Hypertension
  • Hypertension, Systolic
  • Hypertension,Essential

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group 		AVIM therapy activated with continued stable antihypertensive drug therapy
  • Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
    Antihypertensive therapy utilizing atrioventricular interval modulation.
    Other names:
    • BackBeat CNT
Sham Comparator
Control Group 		AVIM therapy deactivated with continued stable antihypertensive drug therapy
  • Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
    AVIM therapy is deactivated

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Orchestra BioMed, Inc

Study Contact

Hans-Peter Stoll, MD, PhD
646-956-2161
hpstoll@orchestrabiomed.com

Detailed 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.