BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Recruiting · NCT06059638 · Interventional (participants receive a specific treatment) · Lead sponsor: Orchestra BioMed, Inc
View the official record on ClinicalTrials.gov →Interventions studied
Medtronic Astra/Azure DR MRI IPG with AVIM therapy ActivatedMedtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
- Office SBP ≥135 mmHg and \<180 mmHg
- Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
Exclusion criteria
- LVEF \<50%
- NYHA Class III-IV
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
- Myocardial infarction (MI) within 3 months
- Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
- Permanent atrial fibrillation
- Mitral valve regurgitation greater than or equal to grade 3
- Aortic stenosis with a valve area less than 1.5 cm2
- Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
- Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
Where it is running
60 locations listed across 29 US states.
- HonorHealth - Scottsdale, Arizona, United States
- Adventist Health Glendale - Glendale, California, United States
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States
- Stanford - Redwood City, California, United States
- Scripps Clinic - San Diego, California, United States
- Sutter Valley Hospitals - San Francisco, California, United States
- South Denver Cardiology - Denver, Colorado, United States
- Colorado Heart and Vascular - Golden, Colorado, United States
- Intermountain Health Lutheran Hospital - Golden, Colorado, United States
- UCHealth Medical Center of the Rockies - Loveland, Colorado, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- HCA Florida JFK Hospital - Atlantis, Florida, United States
- Cardiovascular Research Solutions (MyCardiologist) - Celebration, Florida, United States
- Clearwater Cardiovascular Consultants - Clearwater, Florida, United States
- Citrus Cardiology Consultants - Crystal River, Florida, United States
- The Cardiac and Vascular Institute - Gainesville, Florida, United States
- Memorial Healthcare System - Hollywood, Florida, United States
- Baptist Health Jacksonville - Jacksonville, Florida, United States
- Baptist Health South Florida - Miami, Florida, United States
- Mount Sinai Medical Center of Florida - Miami Beach, Florida, United States
- Sarasota Memorial Hospital - Sarasota, Florida, United States
- Piedmont Healthcare, Inc. - Atlanta, Georgia, United States
- Wellstar Research Institute - Marietta, Georgia, United States
- St. Luke's Idaho Cardiology - Boise, Idaho, United States
- University of Chicago - Chicago, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Cardiovascular Research Institute of Kansas - Wichita, Kansas, United States
- West Houston Area Clinical Trial Consultants (Wichita, KS) - Wichita, Kansas, United States
- Baptist Health Lexington - Lexington, Kentucky, United States
- Ochsner Medical Center - New Orleans, Louisiana, United States
- The Johns Hopkins University - Baltimore, Maryland, United States
- Medstar Union Memorial Hospital - Baltimore, Maryland, United States
- The Brigham and Women's Hospital - Boston, Massachusetts, United States
- St. Elizabeth's Medical Center - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Henry Ford Health - Detroit, Michigan, United States
- UMH-Sparrow Clinical Research - Lansing, Michigan, United States
- Michigan Heart - Ypsilanti, Michigan, United States
- Health Partners Institute (Methodist Heart and Vascular Center) - Bloomington, Minnesota, United States
- Minneapolis Heart Institute - Minneapolis, Minnesota, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Washington University St. Louis - St Louis, Missouri, United States
- The Cooper Health System - Camden, New Jersey, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- Virtua Medical Group, P.A. - Marlton, New Jersey, United States
- Jersey Shore University Medical Center - Neptune City, New Jersey, United States
- The Valley Hospital - Ridgewood, New Jersey, United States
- Lovelace Medical Center (New Mexico Heart Institute) - Albuquerque, New Mexico, United States
- Northwell Health, Inc. - New Hyde Park, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- University of Rochester - Cardiology CCTU - Rochester, New York, United States
- HCA Asheville Cardiology Associates - Asheville, North Carolina, United States
- Atrium Health - Sanger Heart - Charlotte, North Carolina, United States
- WakeMed - Raleigh, North Carolina, United States
- The Lindner Research Center - Cincinnati, Ohio, United States
- The Ohio State University - Columbus, Ohio, United States
- OhioHealth Corporation - Columbus, Ohio, United States
- University of Oklahoma - Oklahoma City, Oklahoma, United States
- Hightower Clinical Trials - Oklahoma City, Oklahoma, United States
- South Oklahoma Heart Research - Oklahoma City, Oklahoma, United States
Showing 60 of 131 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →