Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study.
Zbigniew Kalarus, Béla Merkely, Petr Neužil...
https://pubmed.ncbi.nlm.nih.gov/34387126Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06059638
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Led by Orchestra BioMed, Inc · Updated on 2026-05-27
500
Participants Needed
129
Research Sites
139 weeks
Total Duration
On this page
Sponsors
O
Orchestra BioMed, Inc
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new atrioventricular interval modulation (AVIM) algorithm designed to be used with a dual-chamber Medtronic Astra/Azure pacemaker in patients with hypertension. This multinational, randomized, double-blind clinical trial aims to assess the safety and effectiveness of this novel AVIM therapy compared to standard pacemaker therapy without AVIM activation. Participants include patients scheduled for or already implanted with the Astra/Azure pacemaker who also have high blood pressure. The study has three phases: a screening phase, a double-blind randomized phase lasting one year, and an unblinded phase lasting two years. Eligible patients will have the investigational AVIM software downloaded into their pacemaker and be randomly assigned to either have AVIM therapy turned on or off, while continuing their stable antihypertensive drug treatment. The trial compares AVIM therapy activated versus deactivated alongside ongoing medication to evaluate its impact on blood pressure. Participants will be monitored for changes in their average 24-hour ambulatory systolic blood pressure three months after randomization as the primary outcome. Safety is also assessed by tracking serious unanticipated device effects within the same timeframe. The study involves regular assessments during the randomized and unblinded phases, with continued observation for up to three years. All participants maintain their prescribed antihypertensive medications throughout the study.
CONDITIONS
Brief Title
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient has or is indicated for a dual-chamber pacemaker
- Visit 1 can be performed within 30 days prior to planned implant or anytime after
- On stable antihypertensive treatment with at least one drug class
- Office systolic blood pressure between 135 mmHg and less than 180 mmHg
- Average 24-hour ambulatory systolic blood pressure between 130 mmHg and less than 170 mmHg
You will not qualify if you...
- Left ventricular ejection fraction less than 50%
- New York Heart Association Class III-IV heart failure
- History of stroke or transient ischemic attack within 6 months
- Myocardial infarction within 3 months
- Recent coronary, carotid, or endovascular intervention within 3 months
- Permanent atrial fibrillation
- Mitral valve regurgitation grade 3 or higher
- Aortic stenosis with valve area less than 1.5 cm2
- Prior device-based antihypertensive treatments
- Existing active cardiac device or neurostimulator other than Astra/Azure pacemaker implant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 30 days before planned implant or anytime after
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Double-blind Randomized Phase
Duration - 1 year
Participants are randomly assigned to have AVIM therapy turned ON or OFF while continuing stable antihypertensive drug therapy.
Regular visits during the 1-year treatment phase
Unblinded Phase
Duration - 2 years
Participants continue follow-up after the double-blind phase for an additional 2 years.
Follow-up visits during the 2-year unblinded phase
Trial Site Locations
Total: 129 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
Colorado Heart and Vascular
Golden, Colorado, United States, 80401
Actively Recruiting
9
Intermountain Health Lutheran Hospital
Golden, Colorado, United States, 80401
Actively Recruiting
10
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
11
HCA Florida JFK Hospital
Atlantis, Florida, United States, 33462
Actively Recruiting
12
Cardiovascular Research Solutions (MyCardiologist)
Celebration, Florida, United States, 34747
Actively Recruiting
13
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
Actively Recruiting
14
Citrus Cardiology Consultants
Crystal River, Florida, United States, 34429
Actively Recruiting
15
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Actively Recruiting
16
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Actively Recruiting
17
Baptist Health Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
18
Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
19
Mount Sinai Medical Center of Florida
Miami Beach, Florida, United States, 33140
Actively Recruiting
20
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
21
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States, 30309
Actively Recruiting
22
Wellstar Research Institute
Marietta, Georgia, United States, 30060
Actively Recruiting
23
St. Luke's Idaho Cardiology
Boise, Idaho, United States, 83712
Actively Recruiting
24
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
25
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
26
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas, United States, 67226
Actively Recruiting
27
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
28
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
29
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
30
Medstar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
31
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
32
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Actively Recruiting
33
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
34
Henry Ford Health
Detroit, Michigan, United States, 48202-2689
Actively Recruiting
35
UMH-Sparrow Clinical Research
Lansing, Michigan, United States, 48912
Actively Recruiting
36
Michigan Heart
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
37
Health Partners Institute (Methodist Heart and Vascular Center)
Bloomington, Minnesota, United States, 55425
Actively Recruiting
38
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
39
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
40
Washington University St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
41
The Cooper Health System
Camden, New Jersey, United States, 08103
Actively Recruiting
42
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
43
Virtua Medical Group, P.A.
Marlton, New Jersey, United States, 08053
Actively Recruiting
44
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
45
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Terminated
46
Lovelace Medical Center (New Mexico Heart Institute)
Albuquerque, New Mexico, United States, 87110
Actively Recruiting
47
Northwell Health, Inc.
New Hyde Park, New York, United States, 11042
Withdrawn
48
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
49
University of Rochester - Cardiology CCTU
Rochester, New York, United States, 14642
Not Yet Recruiting
50
HCA Asheville Cardiology Associates
Asheville, North Carolina, United States, 28801
Actively Recruiting
51
Atrium Health - Sanger Heart
Charlotte, North Carolina, United States, 28210
Actively Recruiting
52
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
53
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
54
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
55
OhioHealth Corporation
Columbus, Ohio, United States, 43214
Actively Recruiting
56
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73019
Actively Recruiting
57
Hightower Clinical Trials
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
58
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States, 73135
Actively Recruiting
59
Penn Medicine at Doylestown Health Cardiology
Doylestown, Pennsylvania, United States, 18901
Actively Recruiting
60
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States, 17602
Actively Recruiting
61
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
62
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
63
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
64
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States, 38138
Actively Recruiting
65
Ascension St. Thomas Hospital
Nashville, Tennessee, United States, 37203
Actively Recruiting
66
Ascension Seton
Austin, Texas, United States, 78723
Actively Recruiting
67
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75204
Actively Recruiting
68
Centra Health dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Actively Recruiting
69
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
70
Advocate Aurora Research Institute, LLC
Milwaukee, Wisconsin, United States, 53233
Actively Recruiting
71
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Not Yet Recruiting
72
Alfred Health Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
73
OLV Ziekenhuis
Aalst, Belgium
Actively Recruiting
74
Middelheim Ziekenhuis
Antwerp, Belgium
Actively Recruiting
75
Universite Libre de Bruxelles-Erasme Hospital
Brussels, Belgium
Actively Recruiting
76
UZ Brussel
Brussels, Belgium
Actively Recruiting
77
UZ Leuven
Leuven, Belgium
Actively Recruiting
78
Fakultní nemocnice Královské Vinohrady (FNKV)
Prague, Czechia
Actively Recruiting
79
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
Actively Recruiting
80
Na Homolce Hospital
Prague, Czechia
Actively Recruiting
81
CHU Grenoble
Grenoble, France
Actively Recruiting
82
Hospices Civils de Lyon (HCL)
Lyon, France
Actively Recruiting
83
CHU de Nantes
Nantes, France
Actively Recruiting
84
AP-HP Hôpital Pitié Salpêtrière
Paris, France
Actively Recruiting
85
CHRU Tours
Tours, France
Actively Recruiting
86
Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)
Berlin, Germany
Actively Recruiting
87
Herzzentrum Bonn am Universitätsklinikum Bonn
Bonn, Germany
Actively Recruiting
88
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
Frankfurt, Germany
Actively Recruiting
89
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
90
Herzzentrum Leipzig
Leipzig, Germany
Not Yet Recruiting
91
University Hospital Luebeck
Lübeck, Germany
Actively Recruiting
92
University Medical Centre Mannheim
Mannheim, Germany
Actively Recruiting
93
Saarland University Hospital
Saarbrücken, Germany
Actively Recruiting
94
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Actively Recruiting
95
Central Hospital of Northern Pest - Military Hospital
Budapest, Hungary
Actively Recruiting
96
Semmelweis University
Budapest, Hungary
Actively Recruiting
97
University of Debrecen
Debrecen, Hungary
Actively Recruiting
98
University of Szeged
Szeged, Hungary
Actively Recruiting
99
Policlinico Di Sant Orsola Malpighi
Bologna, Italy
Actively Recruiting
100
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Not Yet Recruiting
101
Campus Bio-Medico University Hospital
Rome, Italy
Actively Recruiting
102
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Actively Recruiting
103
IRCCS Sacro Cuore Don Calabria
Verona, Italy
Actively Recruiting
104
Amsterdam University Medical Centre
Amsterdam, Netherlands
Actively Recruiting
105
Maastricht UMC+
Maastricht, Netherlands
Actively Recruiting
106
Isala Klinieken
Zwolle, Netherlands
Actively Recruiting
107
ChristChurch Hospital
Christchurch, Canterbury, New Zealand, 8140
Not Yet Recruiting
108
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
Actively Recruiting
109
Jagiellonian University Hospital
Krakow, Poland
Actively Recruiting
110
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, Poland
Not Yet Recruiting
111
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
Lublin, Poland
Actively Recruiting
112
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Actively Recruiting
113
Uniwersytecki Szpital Kliniczny nr 2 PUM
Szczecin, Poland
Actively Recruiting
114
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
Actively Recruiting
115
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Poland
Actively Recruiting
116
Silesian Center for Heart Diseases
Zabrze, Poland
Actively Recruiting
117
Hospital Germans Trias i Pujol
Badalona, Spain
Actively Recruiting
118
Hospital Clínico de Barcelona
Barcelona, Spain
Actively Recruiting
119
La Paz University Hospital
Madrid, Spain
Actively Recruiting
120
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Actively Recruiting
121
Universitaetsspital Basel
Basel, Switzerland
Actively Recruiting
122
Universitaetsspital Bern
Bern, Switzerland
Actively Recruiting
123
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Actively Recruiting
124
Cardiocentro Ticino Lugano
Lugano, Switzerland
Actively Recruiting
125
Royal Brompton
London, United Kingdom
Actively Recruiting
126
St. Bartholomew's Hospital
London, United Kingdom
Actively Recruiting
127
St. Thomas Hospital
London, United Kingdom
Actively Recruiting
128
John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
129
Southampton General Hospital
Southhampton, United Kingdom
Actively Recruiting
Loading map...
Research Team
H
Hans-Peter Stoll, MD, PhD
A
Angela Stagg
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Pacemaker-Mediated Programmable Hypertension Control Therapy.
Petr Neuzil, Béla Merkely, Andrejs Erglis...
https://pubmed.ncbi.nlm.nih.gov/29275370