BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Key facts
- Where
- Albuquerque, Asheville, Atlanta, Atlantis, Austin, Baltimore, Bloomington, Boise, Boston, Camden, Celebration, Charleston, Charlotte, Chicago, Cincinnati, Clearwater, Columbus, Crystal River, Dallas, Denver, Detroit, Doylestown, Gainesville, Germantown, Glendale, Golden, Hackensack, Hollywood, Jacksonville, Kansas City, Lancaster, Lansing, Lexington, Loveland, Lynchburg, Marietta, Marlton, Miami, Miami Beach, Milwaukee, Minneapolis, Morgantown, Nashville, Neptune City, New Hyde Park, New Orleans, New York, Newport Beach, Oklahoma City, Philadelphia, Raleigh, Redwood City, Ridgewood, Rochester, San Diego, San Francisco, Sarasota, Scottsdale, St Louis, Washington D.C., Wichita, and Ypsilanti, United StatesSee the 72 sites
Where in United States
- Lovelace Medical Center (New Mexico Heart Institute)Albuquerque, United StatesNo longer taking part
- HCA Asheville Cardiology AssociatesAsheville, United StatesTaking people
- Piedmont Healthcare, IncAtlanta, United StatesNo longer taking part
- HCA Florida JFK HospitalAtlantis, United StatesNo longer taking part
- Ascension SetonAustin, United StatesNo longer taking part
- The Johns Hopkins UniversityBaltimore, United StatesTaking people
- MedStar Union Memorial HospitalBaltimore, United StatesNo longer taking part
- Health Partners Institute (Methodist Heart and Vascular Center)Bloomington, United StatesNo longer taking part
- St. Luke's Idaho CardiologyBoise, United StatesNo longer taking part
- St. Elizabeth's Medical CenterBoston, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- The Brigham and Women's HospitalBoston, United StatesNo longer taking part
- The Cooper Health SystemCamden, United StatesTaking people
- Cardiovascular Research Solutions (MyCardiologist)Celebration, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesTaking people
- Atrium Health - Sanger HeartCharlotte, United StatesNo longer taking part
- University of ChicagoChicago, United StatesTaking people
- The Lindner Research CenterCincinnati, United StatesNo longer taking part
- Clearwater Cardiovascular ConsultantsClearwater, United StatesNo longer taking part
- OhioHealth CorporationColumbus, United StatesNo longer taking part
- The Ohio State UniversityColumbus, United StatesNo longer taking part
- Citrus Cardiology ConsultantsCrystal River, United StatesNo longer taking part
- Baylor Scott & White Research InstituteDallas, United StatesTaking people
- South Denver CardiologyDenver, United StatesNo longer taking part
- Henry Ford HealthDetroit, United StatesNo longer taking part
- Penn Medicine at Doylestown Health CardiologyDoylestown, United StatesNo longer taking part
- The Cardiac and Vascular InstituteGainesville, United StatesNo longer taking part
- Stern Cardiovascular Foundation, Inc.Germantown, United StatesNo longer taking part
- Adventist Health GlendaleGlendale, United StatesTaking people
- Colorado Heart and VascularGolden, United StatesNo longer taking part
- Intermountain Health Lutheran HospitalGolden, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- Memorial Healthcare SystemHollywood, United StatesNo longer taking part
- Baptist Health - JacksonvilleJacksonville, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Penn Medicine Lancaster General HealthLancaster, United StatesNo longer taking part
- UMH-Sparrow Clinical ResearchLansing, United StatesNo longer taking part
- Baptist Health LexingtonLexington, United StatesNo longer taking part
- UCHealth - Medical Center of the RockiesLoveland, United StatesTaking people
- Centra Health dba Stroobants Cardiovascular CenterLynchburg, United StatesNo longer taking part
- WellStar Research InstituteMarietta, United StatesNo longer taking part
- Virtua Medical Group, P.A.Marlton, United StatesTaking people
- Baptist Health South FloridaMiami, United StatesNo longer taking part
- Mount Sinai Medical Center of FloridaMiami Beach, United StatesNo longer taking part
- Advocate Aurora Research Institute, LLCMilwaukee, United StatesNo longer taking part
- Minneapolis Heart InstituteMinneapolis, United StatesTaking people
- West Virginia UniversityMorgantown, United StatesNo longer taking part
- Ascension St. Thomas HospitalNashville, United StatesNo longer taking part
- Jersey Shore University Medical CenterNeptune City, United StatesNo longer taking part
- Northwell Health, Inc.New Hyde Park, United StatesNo longer taking part
- Ochsner Medical CenterNew Orleans, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Hoag Memorial Hospital PresbyterianNewport Beach, United StatesNo longer taking part
- South Oklahoma Heart ResearchOklahoma City, United StatesTaking people
- Hightower Clinical TrialsOklahoma City, United StatesNo longer taking part
- University of OklahomaOklahoma City, United StatesNo longer taking part
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Penn Presbyterian Medical CenterPhiladelphia, United StatesNo longer taking part
- WakemedRaleigh, United StatesNo longer taking part
- StanfordRedwood City, United StatesNo longer taking part
- The Valley HospitalRidgewood, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- University of Rochester - Cardiology CCTURochester, United StatesNo longer taking part
- Scripps ClinicSan Diego, United StatesNo longer taking part
- Sutter Valley HospitalsSan Francisco, United StatesTaking people
- Sarasota Memorial HospitalSarasota, United StatesNo longer taking part
- HonorHealthScottsdale, United StatesNo longer taking part
- Washington University St. LouisSt Louis, United StatesNo longer taking part
- MedStar Washington Hospital CenterWashington D.C., United StatesNo longer taking part
- Cardiovascular Research Institute of KansasWichita, United StatesTaking people
- West Houston Area Clinical Trial Consultants (Wichita, KS)Wichita, United StatesNo longer taking part
- Michigan HeartYpsilanti, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Orchestra BioMed, Inc
- Trial code
- NCT06059638
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months; Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy); History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months; Myocardial infarction (MI) within 3 months; Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant; LVEF <50%; NYHA Class III-IV; Permanent atrial fibrillation; Mitral valve regurgitation greater than or equal to grade 3; Aortic stenosis with a valve area less than 1.5 cm2.