What this study is
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.
What's being tested
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Intervention · DEVICE
Antihypertensive therapy utilizing atrioventricular interval modulation.
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Intervention · DEVICE
AVIM therapy is deactivated
Study details
- Sponsor
- Orchestra BioMed, Inc
- Conditions
- Hypertension · Hypertension, Systolic · Hypertension, Essential
- Enrolling
- 316 people
- Starts
- 2023-12-27
- Est. completion
- 2029-08
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (131)
64 openAdventist Health Glendale
Glendale, California, United States
RecruitingSutter Valley Hospitals
San Francisco, California, United States
RecruitingUCHealth Medical Center of the Rockies
Loveland, Colorado, United States
RecruitingUniversity of Chicago
Chicago, Illinois, United States
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RecruitingCardiovascular Research Institute of Kansas
Wichita, Kansas, United States
RecruitingThe Johns Hopkins University
Baltimore, Maryland, United States
RecruitingSt. Elizabeth's Medical Center
Boston, Massachusetts, United States
RecruitingMinneapolis Heart Institute
Minneapolis, Minnesota, United States
RecruitingThe Cooper Health System
Camden, New Jersey, United States
RecruitingVirtua Medical Group, P.A.
Marlton, New Jersey, United States
RecruitingIcahn School of Medicine at Mount Sinai
New York, New York, United States
RecruitingHCA Asheville Cardiology Associates
Asheville, North Carolina, United States
RecruitingSouth Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
RecruitingBaylor Scott & White Research Institute
Dallas, Texas, United States
RecruitingHonorHealth
Scottsdale, Arizona, United States
Active, not recruitingHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Active, not recruitingStanford
Redwood City, California, United States
Active, not recruitingScripps Clinic
San Diego, California, United States
WithdrawnSouth Denver Cardiology
Denver, Colorado, United States
WithdrawnColorado Heart and Vascular
Golden, Colorado, United States
WithdrawnIntermountain Health Lutheran Hospital
Golden, Colorado, United States
WithdrawnMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Active, not recruitingHCA Florida JFK Hospital
Atlantis, Florida, United States
Active, not recruitingCardiovascular Research Solutions (MyCardiologist)
Celebration, Florida, United States
Active, not recruitingClearwater Cardiovascular Consultants
Clearwater, Florida, United States
Active, not recruitingCitrus Cardiology Consultants
Crystal River, Florida, United States
Active, not recruitingThe Cardiac and Vascular Institute
Gainesville, Florida, United States
Active, not recruitingMemorial Healthcare System
Hollywood, Florida, United States
WithdrawnBaptist Health Jacksonville
Jacksonville, Florida, United States
WithdrawnBaptist Health South Florida
Miami, Florida, United States
WithdrawnMount Sinai Medical Center of Florida
Miami Beach, Florida, United States
WithdrawnSarasota Memorial Hospital
Sarasota, Florida, United States
Active, not recruitingPiedmont Healthcare, Inc.
Atlanta, Georgia, United States
Active, not recruitingWellstar Research Institute
Marietta, Georgia, United States
Active, not recruitingSt. Luke's Idaho Cardiology
Boise, Idaho, United States
Active, not recruitingWest Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas, United States
Active, not recruitingBaptist Health Lexington
Lexington, Kentucky, United States
Active, not recruitingOchsner Medical Center
New Orleans, Louisiana, United States
Active, not recruitingMedstar Union Memorial Hospital
Baltimore, Maryland, United States
WithdrawnThe Brigham and Women's Hospital
Boston, Massachusetts, United States
WithdrawnBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
WithdrawnHenry Ford Health
Detroit, Michigan, United States
Active, not recruitingUMH-Sparrow Clinical Research
Lansing, Michigan, United States
Active, not recruitingMichigan Heart
Ypsilanti, Michigan, United States
Active, not recruitingHealth Partners Institute (Methodist Heart and Vascular Center)
Bloomington, Minnesota, United States
Active, not recruitingMayo Clinic
Rochester, Minnesota, United States
WithdrawnWashington University St. Louis
St Louis, Missouri, United States
Active, not recruitingHackensack University Medical Center
Hackensack, New Jersey, United States
Active, not recruitingJersey Shore University Medical Center
Neptune City, New Jersey, United States
WithdrawnThe Valley Hospital
Ridgewood, New Jersey, United States
WithdrawnLovelace Medical Center (New Mexico Heart Institute)
Albuquerque, New Mexico, United States
WithdrawnNorthwell Health, Inc.
New Hyde Park, New York, United States
WithdrawnUniversity of Rochester - Cardiology CCTU
Rochester, New York, United States
WithdrawnAtrium Health - Sanger Heart
Charlotte, North Carolina, United States
Active, not recruitingWakeMed
Raleigh, North Carolina, United States
WithdrawnThe Lindner Research Center
Cincinnati, Ohio, United States
WithdrawnThe Ohio State University
Columbus, Ohio, United States
WithdrawnOhioHealth Corporation
Columbus, Ohio, United States
WithdrawnUniversity of Oklahoma
Oklahoma City, Oklahoma, United States
WithdrawnHightower Clinical Trials
Oklahoma City, Oklahoma, United States
Active, not recruitingPenn Medicine at Doylestown Health Cardiology
Doylestown, Pennsylvania, United States
WithdrawnPenn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States
WithdrawnHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Active, not recruitingPenn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
WithdrawnStern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States
Active, not recruitingAscension St. Thomas Hospital
Nashville, Tennessee, United States
Active, not recruitingAscension Seton
Austin, Texas, United States
Active, not recruitingCentra Health dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
Active, not recruitingWest Virginia University
Morgantown, West Virginia, United States
WithdrawnAdvocate Aurora Research Institute, LLC
Milwaukee, Wisconsin, United States
Active, not recruiting
59 sites outside the US
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
RecruitingMiddelheim Ziekenhuis
Antwerp, Belgium
RecruitingUniversite Libre de Bruxelles-Erasme Hospital
Brussels, Belgium
RecruitingUZ Leuven
Leuven, Belgium
RecruitingNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RecruitingJiangsu Province Hospital
Nanjing, China
RecruitingFakultní nemocnice Královské Vinohrady (FNKV)
Prague, Czechia
RecruitingInstitute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
RecruitingNa Homolce Hospital
Prague, Czechia
RecruitingCHU Grenoble
Grenoble, France
RecruitingHospices Civils de Lyon (HCL)
Lyon, France
RecruitingCHU de Nantes
Nantes, France
RecruitingAP-HP Hôpital Pitié Salpêtrière
Paris, France
RecruitingCHRU Tours
Tours, France
RecruitingUniversitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)
Berlin, Germany
RecruitingCardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
Frankfurt, Germany
RecruitingHerzzentrum Leipzig
Leipzig, Germany
RecruitingUniversity Hospital Luebeck
Lübeck, Germany
RecruitingUniversity Medical Centre Mannheim
Mannheim, Germany
RecruitingSaarland University Hospital
Saarbrücken, Germany
RecruitingSemmelweis University
Budapest, Hungary
RecruitingUniversity of Debrecen
Debrecen, Hungary
RecruitingUniversity of Szeged
Szeged, Hungary
RecruitingCampus Bio-Medico University Hospital
Rome, Italy
RecruitingAzienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
RecruitingIRCCS Sacro Cuore Don Calabria
Verona, Italy
RecruitingAmsterdam University Medical Centre
Amsterdam, Netherlands
RecruitingMaastricht UMC+
Maastricht, Netherlands
RecruitingIsala Klinieken
Zwolle, Netherlands
RecruitingChristChurch Hospital
Christchurch, Canterbury, New Zealand
RecruitingGórnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
RecruitingJagiellonian University Hospital
Krakow, Poland
RecruitingCentralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, Poland
RecruitingWojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
Lublin, Poland
RecruitingUniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
RecruitingUniwersytecki Szpital Kliniczny nr 2 PUM
Szczecin, Poland
RecruitingUniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
RecruitingUniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Poland
RecruitingSilesian Center for Heart Diseases
Zabrze, Poland
RecruitingHospital Germans Trias i Pujol
Badalona, Spain
RecruitingLa Paz University Hospital
Madrid, Spain
RecruitingHospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
RecruitingHôpitaux Universitaires de Genève
Geneva, Switzerland
RecruitingRoyal Brompton
London, United Kingdom
RecruitingSt. Bartholomew's Hospital
London, United Kingdom
RecruitingSt. Thomas Hospital
London, United Kingdom
RecruitingJohn Radcliffe Hospital
Oxford, United Kingdom
RecruitingSouthampton General Hospital
Southhampton, United Kingdom
RecruitingOLV Ziekenhuis
Aalst, Belgium
WithdrawnUZ Brussel
Brussels, Belgium
WithdrawnHerzzentrum Bonn am Universitätsklinikum Bonn
Bonn, Germany
WithdrawnUniversitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
WithdrawnKrankenhaus der Barmherzigen Brüder Trier
Trier, Germany
WithdrawnCentral Hospital of Northern Pest - Military Hospital
Budapest, Hungary
WithdrawnPoliclinico Di Sant Orsola Malpighi
Bologna, Italy
WithdrawnHospital Clínico de Barcelona
Barcelona, Spain
WithdrawnUniversitaetsspital Basel
Basel, Switzerland
WithdrawnUniversitaetsspital Bern
Bern, Switzerland
WithdrawnCardiocentro Ticino Lugano
Lugano, Switzerland
Withdrawn
Study team
Sponsor
Orchestra BioMed, Inc
Study ID CS-08
Principal investigator
David Kandzari, MD
Piedmont Heart Institute
Principal investigator
Andrea Russo, MD
Cooper University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.