BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Not Applicable

Recruiting

• Conditions: Hypertension; Hypertension, Systolic; Hypertension, Essential

• Registration Number: NCT06059638
• Lead Sponsor: Orchestra BioMed, Inc

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.

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 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.

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Study Start: 2023-12-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-09-23
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-12
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months	Baseline and 3 months post randomization	Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE)	3 months post randomization	Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.

Trial Locations

Locations (78)

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Stanford; 🇺🇸 Redwood City, California, United States

Scripps Clinic; 🇺🇸 San Diego, California, United States

Sutter Valley Hospitals; 🇺🇸 San Francisco, California, United States

Intermountain Health Lutheran Hospital; 🇺🇸 Golden, Colorado, United States

MedStar Washington Hospital Center; 🇺🇸 Washington D.C., District of Columbia, United States

Clearwater Cardiovascular Consultants; 🇺🇸 Clearwater, Florida, United States

Citrus Cardiology Consultants; 🇺🇸 Crystal River, Florida, United States

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States

Baptist Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

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