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Clinical Trials in Czechia / NCT06059638
Recruiting Not applicable

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

NCT06059638 · tracked via the Priya Life Science Czechia tracker
Sponsor
Orchestra BioMed, Inc
Phase
Not applicable
Started
2023-12-27
Last updated
2026-10-02

Condition(s) studied

HypertensionHypertension, SystolicHypertension, Essential

Investigational drug(s) / intervention(s)

Medtronic Astra/Azure DR MRI IPG with AVIM therapy ActivatedMedtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (131)

FacilityCityRegionStatus
HonorHealth Scottsdale Arizona Active Not Recruiting
Adventist Health Glendale Glendale California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Active Not Recruiting
Stanford Redwood City California Active Not Recruiting
Scripps Clinic San Diego California Withdrawn
Sutter Valley Hospitals San Francisco California Recruiting
South Denver Cardiology Denver Colorado Withdrawn
Colorado Heart and Vascular Golden Colorado Withdrawn
Intermountain Health Lutheran Hospital Golden Colorado Withdrawn
UCHealth Medical Center of the Rockies Loveland Colorado Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Active Not Recruiting
HCA Florida JFK Hospital Atlantis Florida Active Not Recruiting
Cardiovascular Research Solutions (MyCardiologist) Celebration Florida Active Not Recruiting
Clearwater Cardiovascular Consultants Clearwater Florida Active Not Recruiting
Citrus Cardiology Consultants Crystal River Florida Active Not Recruiting
The Cardiac and Vascular Institute Gainesville Florida Active Not Recruiting
Memorial Healthcare System Hollywood Florida Withdrawn
Baptist Health Jacksonville Jacksonville Florida Withdrawn
Baptist Health South Florida Miami Florida Withdrawn
Mount Sinai Medical Center of Florida Miami Beach Florida Withdrawn
Sarasota Memorial Hospital Sarasota Florida Active Not Recruiting
Piedmont Healthcare, Inc. Atlanta Georgia Active Not Recruiting
Wellstar Research Institute Marietta Georgia Active Not Recruiting
St. Luke's Idaho Cardiology Boise Idaho Active Not Recruiting
University of Chicago Chicago Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Cardiovascular Research Institute of Kansas Wichita Kansas Recruiting
West Houston Area Clinical Trial Consultants (Wichita, KS) Wichita Kansas Active Not Recruiting
Baptist Health Lexington Lexington Kentucky Active Not Recruiting
Ochsner Medical Center New Orleans Louisiana Active Not Recruiting
The Johns Hopkins University Baltimore Maryland Recruiting
Medstar Union Memorial Hospital Baltimore Maryland Withdrawn
The Brigham and Women's Hospital Boston Massachusetts Withdrawn
St. Elizabeth's Medical Center Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Withdrawn
Henry Ford Health Detroit Michigan Active Not Recruiting
UMH-Sparrow Clinical Research Lansing Michigan Active Not Recruiting
Michigan Heart Ypsilanti Michigan Active Not Recruiting
Health Partners Institute (Methodist Heart and Vascular Center) Bloomington Minnesota Active Not Recruiting
Minneapolis Heart Institute Minneapolis Minnesota Recruiting

+ 91 more sites — see the full list on the official registry below.

Other trials for the same condition

A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 Active, not recruiting
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease Recruiting
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Enrolling by invitation
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Recruiting
Novel Setup Algorithm for Cardiac Neuromodulation Therapy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06059638 on ClinicalTrials.gov ↗ ← All trials in Czechia