Actively Recruiting
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Led by Orchestra BioMed, Inc · Updated on 2026-04-17
500
Participants Needed
99
Research Sites
292 weeks
Total Duration
On this page
Sponsors
O
Orchestra BioMed, Inc
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has or is indicated for a dual-chamber pacemaker, with visit 1 within 30 days before or any time after planned implantation of a Medtronic Astra/Azure dual-chamber pacemaker system
- On a stable blood pressure treatment plan with at least one class of antihypertensive medication
- Office systolic blood pressure of 135 mmHg or higher and less than 180 mmHg
- Average 24-hour ambulatory systolic blood pressure of 130 mmHg or higher and less than 170 mmHg
You will not qualify if you...
- Left ventricular ejection fraction less than 50%
- New York Heart Association Class III or IV heart failure
- History of stroke or transient ischemic attack within the last 6 months
- Heart attack within the last 3 months
- Percutaneous or surgical coronary, carotid, or endovascular intervention within the last 3 months
- Permanent atrial fibrillation
- Mitral valve regurgitation of grade 3 or higher
- Aortic valve stenosis with valve area less than 1.5 cm squared
- Previous or active device-based blood pressure treatment such as renal denervation or baroreflex activation therapy
- Presence of an active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 99 locations
1
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Adventist Health Glendale
Glendale, California, United States, 91206
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92633
Actively Recruiting
4
Stanford
Redwood City, California, United States, 94063
Actively Recruiting
5
Scripps Clinic
San Diego, California, United States, 92121
Actively Recruiting
6
Sutter Valley Hospitals
San Francisco, California, United States, 94109
Actively Recruiting
7
South Denver Cardiology
Denver, Colorado, United States, 80210
Actively Recruiting
8
Intermountain Health Lutheran Hospital
Golden, Colorado, United States, 80401
Actively Recruiting
9
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
10
HCA Florida JFK Hospital
Atlantis, Florida, United States, 33462
Actively Recruiting
11
Cardiovascular Research Solutions (MyCardiologist)
Celebration, Florida, United States, 34747
Actively Recruiting
12
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
Actively Recruiting
13
Citrus Cardiology Consultants
Crystal River, Florida, United States, 34429
Actively Recruiting
14
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Actively Recruiting
15
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Actively Recruiting
16
Baptist Health Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
17
Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
18
Mount Sinai Medical Center of Florida
Miami Beach, Florida, United States, 33140
Actively Recruiting
19
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
20
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States, 30309
Actively Recruiting
21
Wellstar Research Institute
Marietta, Georgia, United States, 30060
Actively Recruiting
22
St. Luke's Idaho Cardiology
Boise, Idaho, United States, 83712
Actively Recruiting
23
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
24
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
25
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas, United States, 67226
Actively Recruiting
26
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
27
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
28
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
29
Medstar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
30
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
31
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Actively Recruiting
32
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
33
Henry Ford Health
Detroit, Michigan, United States, 48202-2689
Actively Recruiting
34
UMH-Sparrow Clinical Research
Lansing, Michigan, United States, 48912
Actively Recruiting
35
Michigan Heart
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
36
Health Partners Institute (Methodist Heart and Vascular Center)
Bloomington, Minnesota, United States, 55425
Actively Recruiting
37
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
38
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
39
Washington University St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
40
The Cooper Health System
Camden, New Jersey, United States, 08103
Actively Recruiting
41
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
42
Virtua Medical Group, P.A.
Marlton, New Jersey, United States, 08053
Actively Recruiting
43
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
44
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Terminated
45
Lovelace Medical Center (New Mexico Heart Institute)
Albuquerque, New Mexico, United States, 87110
Actively Recruiting
46
Northwell Health, Inc.
New Hyde Park, New York, United States, 11042
Withdrawn
47
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
48
HCA Asheville Cardiology Associates
Asheville, North Carolina, United States, 28801
Actively Recruiting
49
Atrium Health - Sanger Heart
Charlotte, North Carolina, United States, 28210
Actively Recruiting
50
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
51
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
52
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
53
OhioHealth Corporation
Columbus, Ohio, United States, 43214
Actively Recruiting
54
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73019
Actively Recruiting
55
Hightower Clinical Trials
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
56
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States, 73135
Actively Recruiting
57
Penn Medicine at Doylestown Health Cardiology
Doylestown, Pennsylvania, United States, 18901
Actively Recruiting
58
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States, 17602
Actively Recruiting
59
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
60
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
61
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
62
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States, 38138
Actively Recruiting
63
Ascension St. Thomas Hospital
Nashville, Tennessee, United States, 37203
Actively Recruiting
64
Ascension Seton
Austin, Texas, United States, 78723
Actively Recruiting
65
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75204
Actively Recruiting
66
Centra Health dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Actively Recruiting
67
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
68
Advocate Aurora Research Institute, LLC
Milwaukee, Wisconsin, United States, 53233
Actively Recruiting
69
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Not Yet Recruiting
70
Alfred Health Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
71
OLV Ziekenhuis
Aalst, Belgium
Actively Recruiting
72
Middelheim Ziekenhuis
Antwerp, Belgium
Actively Recruiting
73
Universite Libre de Bruxelles-Erasme Hospital
Brussels, Belgium
Actively Recruiting
74
UZ Brussel
Brussels, Belgium
Actively Recruiting
75
UZ Leuven
Leuven, Belgium
Actively Recruiting
76
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
Actively Recruiting
77
Na Homolce Hospital
Prague, Czechia
Actively Recruiting
78
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
Frankfurt, Germany
Actively Recruiting
79
University Medical Centre Mannheim
Mannheim, Germany
Actively Recruiting
80
Saarland University Hospital
Saarbrücken, Germany
Actively Recruiting
81
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Actively Recruiting
82
Semmelweis University
Budapest, Hungary
Actively Recruiting
83
University of Debrecen
Debrecen, Hungary
Actively Recruiting
84
Amsterdam University Medical Centre
Amsterdam, Netherlands
Actively Recruiting
85
Maastricht UMC+
Maastricht, Netherlands
Actively Recruiting
86
ChristChurch Hospital
Christchurch, Canterbury, New Zealand, 8140
Not Yet Recruiting
87
Jagiellonian University Hospital
Krakow, Poland
Actively Recruiting
88
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Actively Recruiting
89
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
Actively Recruiting
90
Silesian Center for Heart Diseases
Zabrze, Poland
Actively Recruiting
91
Hospital Germans Trias i Pujol
Badalona, Spain
Actively Recruiting
92
Hospital Clínico de Barcelona
Barcelona, Spain
Actively Recruiting
93
La Paz University Hospital
Madrid, Spain
Actively Recruiting
94
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Actively Recruiting
95
Royal Brompton
London, United Kingdom
Actively Recruiting
96
St. Bartholomew's Hospital
London, United Kingdom
Actively Recruiting
97
St. Thomas Hospital
London, United Kingdom
Actively Recruiting
98
John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
99
Southampton General Hospital
Southhampton, United Kingdom
Actively Recruiting
Research Team
H
Hans-Peter Stoll, MD, PhD
CONTACT
A
Angela Stagg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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