Recruiting

Bradycardia Pacemaker

Sponsor:

Orchestra BioMed, Inc

Code:

NCT06059638

Conditions

Hypertension

Hypertension, Systolic

Hypertension, Essential

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Study Details

Brief summary:

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

Hypertension

Hypertension, Systolic

Hypertension, Essential

Study ID

NCT06059638

Start date

Dec 27, 2023

Status verified date

Sep, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

AVIM therapy activated with continued stable antihypertensive drug therapy

sham comparator: Control Group

AVIM therapy deactivated with continued stable antihypertensive drug therapy

Interventions

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Antihypertensive therapy utilizing atrioventricular interval modulation.

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

AVIM therapy is deactivated

Primary outcome measure

  • Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months [ Time Frame: Baseline and 3 months post randomization ]
  • Freedom from Unanticipated Serious Adverse Device Effects (USADE) [ Time Frame: 3 months post randomization ]

Central Contacts and Locations

Central contacts

Locations

Adventist Health Glendale

Recruiting

Glendale, California, United States, 91206

Sutter Valley Hospitals

Recruiting

San Francisco, California, United States, 94109

UCHealth Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Cardiovascular Research Institute of Kansas

Recruiting

Wichita, Kansas, United States, 67226

The Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

St. Elizabeth's Medical Center

Recruiting

Boston, Massachusetts, United States, 02135

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

The Cooper Health System

Recruiting

Camden, New Jersey, United States, 08103

Virtua Medical Group, P.A.

Recruiting

Marlton, New Jersey, United States, 08053

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

HCA Asheville Cardiology Associates

Recruiting

Asheville, North Carolina, United States, 28801

South Oklahoma Heart Research

Recruiting

Oklahoma City, Oklahoma, United States, 73135

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75204

More Information

Sponsor

Orchestra BioMed, Inc

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Orchestra BioMed, Inc on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.