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BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
NCT06059638 · Orchestra BioMed, Inc
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
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
Enrollment target: 500 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2023-12-27
Estimated completion: 2029-08
Last updated: 2026-04-17
Interventions
Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy ActivatedDevice: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Primary outcomes
- • Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months (Baseline and 3 months post randomization)
- • Freedom from Unanticipated Serious Adverse Device Effects (USADE) (3 months post randomization)
Sponsor
Orchestra BioMed, Inc · industry
With: Medtronic
Contacts & investigators
ContactHans-Peter Stoll, MD, PhD · contact · hpstoll@orchestrabiomed.com · 646-956-2161
ContactAngela Stagg · contact · astagg@orchestrabiomed.com
InvestigatorDavid Kandzari, MD · principal_investigator, Piedmont Heart Institute
InvestigatorAndrea Russo, MD · principal_investigator, Cooper University
All locations (99)
HonorHealthRecruiting
Scottsdale, Arizona, United States
Adventist Health GlendaleRecruiting
Glendale, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
StanfordRecruiting
Redwood City, California, United States
Scripps ClinicRecruiting
San Diego, California, United States
Sutter Valley HospitalsRecruiting
San Francisco, California, United States
South Denver CardiologyRecruiting
Denver, Colorado, United States
Intermountain Health Lutheran HospitalRecruiting
Golden, Colorado, United States
MedStar Washington Hospital CenterRecruiting
Washington D.C., District of Columbia, United States
HCA Florida JFK HospitalRecruiting
Atlantis, Florida, United States
Cardiovascular Research Solutions (MyCardiologist)Recruiting
Celebration, Florida, United States
Clearwater Cardiovascular ConsultantsRecruiting
Clearwater, Florida, United States
Citrus Cardiology ConsultantsRecruiting
Crystal River, Florida, United States
The Cardiac and Vascular InstituteRecruiting
Gainesville, Florida, United States
Memorial Healthcare SystemRecruiting
Hollywood, Florida, United States
Baptist Health JacksonvilleRecruiting
Jacksonville, Florida, United States
Baptist Health South FloridaRecruiting
Miami, Florida, United States
Mount Sinai Medical Center of FloridaRecruiting
Miami Beach, Florida, United States
Sarasota Memorial HospitalRecruiting
Sarasota, Florida, United States
Piedmont Healthcare, Inc.Recruiting
Atlanta, Georgia, United States
Wellstar Research InstituteRecruiting
Marietta, Georgia, United States
St. Luke's Idaho CardiologyRecruiting
Boise, Idaho, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
West Houston Area Clinical Trial Consultants (Wichita, KS)Recruiting
Wichita, Kansas, United States
Baptist Health LexingtonRecruiting
Lexington, Kentucky, United States
Ochsner Medical CenterRecruiting
New Orleans, Louisiana, United States
The Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Medstar Union Memorial HospitalRecruiting
Baltimore, Maryland, United States
The Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
St. Elizabeth's Medical CenterRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
UMH-Sparrow Clinical ResearchRecruiting
Lansing, Michigan, United States
Michigan HeartRecruiting
Ypsilanti, Michigan, United States
Health Partners Institute (Methodist Heart and Vascular Center)Recruiting
Bloomington, Minnesota, United States
Minneapolis Heart InstituteRecruiting
Minneapolis, Minnesota, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Washington University St. LouisRecruiting
St Louis, Missouri, United States
The Cooper Health SystemRecruiting
Camden, New Jersey, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Virtua Medical Group, P.A.Recruiting
Marlton, New Jersey, United States
Jersey Shore University Medical CenterRecruiting
Neptune City, New Jersey, United States
The Valley HospitalTerminated
Ridgewood, New Jersey, United States
Lovelace Medical Center (New Mexico Heart Institute)Recruiting
Albuquerque, New Mexico, United States
Northwell Health, Inc.Withdrawn
New Hyde Park, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
HCA Asheville Cardiology AssociatesRecruiting
Asheville, North Carolina, United States
Atrium Health - Sanger HeartRecruiting
Charlotte, North Carolina, United States
WakeMedRecruiting
Raleigh, North Carolina, United States
The Lindner Research CenterRecruiting
Cincinnati, Ohio, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
OhioHealth CorporationRecruiting
Columbus, Ohio, United States
University of OklahomaRecruiting
Oklahoma City, Oklahoma, United States
Hightower Clinical TrialsRecruiting
Oklahoma City, Oklahoma, United States
South Oklahoma Heart ResearchRecruiting
Oklahoma City, Oklahoma, United States
Penn Medicine at Doylestown Health CardiologyRecruiting
Doylestown, Pennsylvania, United States
Penn Medicine Lancaster General HealthRecruiting
Lancaster, Pennsylvania, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical CenterRecruiting
Philadelphia, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Stern Cardiovascular Foundation, Inc.Recruiting
Germantown, Tennessee, United States
Ascension St. Thomas HospitalRecruiting
Nashville, Tennessee, United States
Ascension SetonRecruiting
Austin, Texas, United States
Baylor Scott & White Research InstituteRecruiting
Dallas, Texas, United States
Centra Health dba Stroobants Cardiovascular CenterRecruiting
Lynchburg, Virginia, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
Advocate Aurora Research Institute, LLCRecruiting
Milwaukee, Wisconsin, United States
Lyell McEwin HospitalNot Yet Recruiting
Elizabeth Vale, South Australia, Australia
Alfred Health HospitalNot Yet Recruiting
Melbourne, Victoria, Australia
OLV ZiekenhuisRecruiting
Aalst, Belgium
Middelheim ZiekenhuisRecruiting
Antwerp, Belgium
Universite Libre de Bruxelles-Erasme HospitalRecruiting
Brussels, Belgium
UZ BrusselRecruiting
Brussels, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
Institute for Clinical and Experimental Medicine (IKEM)Recruiting
Prague, Czechia
Na Homolce HospitalRecruiting
Prague, Czechia
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus KrankenhausRecruiting
Frankfurt, Germany
University Medical Centre MannheimRecruiting
Mannheim, Germany
Saarland University HospitalRecruiting
Saarbrücken, Germany
Krankenhaus der Barmherzigen Brüder TrierRecruiting
Trier, Germany
Semmelweis UniversityRecruiting
Budapest, Hungary
University of DebrecenRecruiting
Debrecen, Hungary
Amsterdam University Medical CentreRecruiting
Amsterdam, Netherlands
Maastricht UMC+Recruiting
Maastricht, Netherlands
ChristChurch HospitalNot Yet Recruiting
Christchurch, Canterbury, New Zealand
Jagiellonian University HospitalRecruiting
Krakow, Poland
Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
Poznan, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoRecruiting
Warsaw, Poland
Silesian Center for Heart DiseasesRecruiting
Zabrze, Poland
Hospital Germans Trias i PujolRecruiting
Badalona, Spain
Hospital Clínico de BarcelonaRecruiting
Barcelona, Spain
La Paz University HospitalRecruiting
Madrid, Spain
Hospital Universitario Nuestra Señora de CandelariaRecruiting
Santa Cruz de Tenerife, Spain
Royal BromptonRecruiting
London, United Kingdom
St. Bartholomew's HospitalRecruiting
London, United Kingdom
St. Thomas HospitalRecruiting
London, United Kingdom
John Radcliffe HospitalRecruiting
Oxford, United Kingdom
Southampton General HospitalRecruiting
Southhampton, United Kingdom