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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 dual-chamber Medtronic Astra/Azure pacemaker.

Conditions

Eligibility

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

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

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.