BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
- Conditions
- HypertensionHypertension, SystolicHypertension, Essential
- Interventions
- Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy ActivatedDevice: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
- Registration Number
- NCT06059638
- Lead Sponsor
- Orchestra BioMed, Inc
- Brief Summary
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.
- Detailed Description
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 who are scheduled to undergo implantation of a, or already have an implanted, de novo Astra/Azure pacemaker system, who also have uncontrolled hypertension may be screened for inclusion into this study. All eligible subjects will receive the AVIM RAMware and be randomized 1:1 to either have AVIM therapy turned On or turned Off. All subjects will continue to receive antihypertensive drug therapy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Patient has or is indicated for a de novo dual chamber pacemaker. Patient informed consent must be obtained within 30 days prior to a planned de novo implant of a Medtronic Astra/Azure dual chamber pacemaker system or up to 365 days after
- On a stable antihypertension treatment regimen with 1, 2, or 3 classes of antihypertensive drugs
- Office SBP ≥140 mmHg and <180 mmHg
- Average 24-Hour aSBP ≥130 mmHg and <170 mmHg
- LVEF <50%
- NYHA Class II-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
- Persistent or permanent atrial fibrillation
- Mitral valve regurgitation greater than 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated AVIM therapy activated with continued stable antihypertensive drug therapy Control Group Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated AVIM therapy deactivated with continued stable antihypertensive drug therapy
- Primary Outcome Measures
Name Time Method Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months Baseline and 3 months post randomization Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE) 3 months post randomization Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (64)
Na Homolce Hospital
🇨🇿Prague, Czechia
HonorHealth
🇺🇸Scottsdale, Arizona, United States
Stanford
🇺🇸Redwood City, California, United States
Scripps Clinic
🇺🇸San Diego, California, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Citrus Cardiology Consultants
🇺🇸Crystal River, Florida, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Baptist Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Mount Sinai Medical Center of Florida
🇺🇸Miami Beach, Florida, United States
Baptist Health South Florida
🇺🇸Miami, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Piedmont Healthcare, Inc.
🇺🇸Atlanta, Georgia, 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
The Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University St. Louis
🇺🇸Saint 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
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Northwell Health, Inc.
🇺🇸New Hyde Park, New York, 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
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
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
OLV Ziekenhuis
🇧🇪Aalst, Belgium
Middelheim Ziekenhuis
🇧🇪Antwerp, Belgium
Universite Libre de Bruxelles-Erasme Hospital
🇧🇪Brussels, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Institute for Clinical and Experimental Medicine (IKEM)
🇨🇿Prague, Czechia
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
🇩🇪Frankfurt, Germany
University Medical Centre Mannheim
🇩🇪Mannheim, Germany
Semmelweis University
🇭🇺Budapest, Hungary
University of Debrecen
🇭🇺Debrecen, Hungary
Amsterdam University Medical Centre
🇳🇱Amsterdam, Netherlands
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
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