BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
NCT ID: NCT06059638
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2023-12-27
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment Group
AVIM therapy activated with continued stable antihypertensive drug therapy
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
Control Group
AVIM therapy deactivated with continued stable antihypertensive drug therapy
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Orchestra BioMed, Inc
INDUSTRY
Medtronic
INDUSTRY
Responsible Party
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Principal Investigators
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David Kandzari, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Andrea Russo, MD
Role: PRINCIPAL_INVESTIGATOR
Cooper University
Locations
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HonorHealth
Scottsdale, Arizona, United States
Adventist Health Glendale
Glendale, 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
Intermountain Health Lutheran Hospital
Golden, 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
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
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
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States
Ascension St. Thomas Hospital
Nashville, Tennessee, United States
Ascension Seton
Austin, Texas, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Centra Health dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Advocate Aurora Research Institute, LLC
Milwaukee, Wisconsin, United States
OLV Ziekenhuis
Aalst, , Belgium
Middelheim Ziekenhuis
Antwerp, , Belgium
Universite Libre de Bruxelles-Erasme Hospital
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Institute for Clinical and Experimental Medicine (IKEM)
Prague, , Czechia
Na Homolce Hospital
Prague, , Czechia
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
Frankfurt, , Germany
University Medical Centre Mannheim
Mannheim, , Germany
Saarland University Hospital
Saarbrücken, , Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, , Germany
Semmelweis University
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Amsterdam University Medical Centre
Amsterdam, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
Jagiellonian University Hospital
Krakow, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, , Poland
Silesian Center for Heart Diseases
Zabrze, , Poland
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Clínico de Barcelona
Barcelona, , Spain
La Paz University Hospital
Madrid, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Royal Brompton
London, , United Kingdom
St. Bartholomew's Hospital
London, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southhampton, , United Kingdom
Countries
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Central Contacts
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References
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Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13.
Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974.
Other Identifiers
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CS-08
Identifier Type: -
Identifier Source: org_study_id
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