BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Status: Recruiting
Location: See all (92) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
• Office SBP ≥135 mmHg and \<180 mmHg
• Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
Locations
United States
Arizona
HonorHealth
RECRUITING
Scottsdale
California
Adventist Health Glendale
RECRUITING
Glendale
Stanford
RECRUITING
Redwood City
Scripps Clinic
RECRUITING
San Diego
Sutter Valley Hospitals
RECRUITING
San Francisco
Colorado
South Denver Cardiology
RECRUITING
Denver
Intermountain Health Lutheran Hospital
RECRUITING
Golden
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
HCA Florida JFK Hospital
RECRUITING
Atlantis
Cardiovascular Research Solutions (MyCardiologist)
RECRUITING
Celebration
Clearwater Cardiovascular Consultants
RECRUITING
Clearwater
Citrus Cardiology Consultants
RECRUITING
Crystal River
The Cardiac and Vascular Institute
RECRUITING
Gainesville
Memorial Healthcare System
RECRUITING
Hollywood
Baptist Health Jacksonville
RECRUITING
Jacksonville
Baptist Health South Florida
RECRUITING
Miami
Mount Sinai Medical Center of Florida
RECRUITING
Miami Beach
Sarasota Memorial Hospital
RECRUITING
Sarasota
Georgia
Piedmont Healthcare, Inc.
RECRUITING
Atlanta
Wellstar Research Institute
RECRUITING
Marietta
Idaho
St. Luke's Idaho Cardiology
RECRUITING
Boise
Illinois
University of Chicago
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
West Houston Area Clinical Trial Consultants (Wichita, KS)
RECRUITING
Wichita
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
Louisiana
Ochsner Medical Center
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
St. Elizabeth's Medical Center
RECRUITING
Boston
The Brigham and Women's Hospital
RECRUITING
Boston
Maryland
Medstar Union Memorial Hospital
RECRUITING
Baltimore
The Johns Hopkins University
RECRUITING
Baltimore
Michigan
Henry Ford Health
RECRUITING
Detroit
UMH-Sparrow Clinical Research
RECRUITING
Lansing
Michigan Heart
RECRUITING
Ypsilanti
Minnesota
Health Partners Institute (Methodist Heart and Vascular Center)
RECRUITING
Bloomington
Minneapolis Heart Institute
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University St. Louis
RECRUITING
St Louis
North Carolina
HCA Asheville Cardiology Associates
RECRUITING
Asheville
Atrium Health - Sanger Heart
RECRUITING
Charlotte
WakeMed
RECRUITING
Raleigh
New Jersey
The Cooper Health System
RECRUITING
Camden
Hackensack University Medical Center
RECRUITING
Hackensack
Virtua Medical Group, P.A.
RECRUITING
Marlton
Jersey Shore University Medical Center
RECRUITING
Neptune City
The Valley Hospital
TERMINATED
Ridgewood
New Mexico
Lovelace Medical Center (New Mexico Heart Institute)
RECRUITING
Albuquerque
New York
Northwell Health, Inc.
WITHDRAWN
New Hyde Park
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
The Lindner Research Center
RECRUITING
Cincinnati
OhioHealth Corporation
RECRUITING
Columbus
The Ohio State University
RECRUITING
Columbus
Oklahoma
Hightower Clinical Trials
RECRUITING
Oklahoma City
South Oklahoma Heart Research
RECRUITING
Oklahoma City
University of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
Penn Medicine Lancaster General Health
RECRUITING
Lancaster
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Penn Presbyterian Medical Center
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Stern Cardiovascular Foundation, Inc.
RECRUITING
Germantown
Ascension St. Thomas Hospital
RECRUITING
Nashville
Texas
Ascension Seton
RECRUITING
Austin
Baylor Scott & White Research Institute
RECRUITING
Dallas
Virginia
Centra Health dba Stroobants Cardiovascular Center
RECRUITING
Lynchburg
Wisconsin
Advocate Aurora Research Institute, LLC
RECRUITING
Milwaukee
West Virginia
West Virginia University
RECRUITING
Morgantown
Other Locations
Belgium
OLV Ziekenhuis
RECRUITING
Aalst
Middelheim Ziekenhuis
RECRUITING
Antwerp
Universite Libre de Bruxelles-Erasme Hospital
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
UZ Leuven
RECRUITING
Leuven
Germany
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
RECRUITING
Frankfurt
University Medical Centre Mannheim
RECRUITING
Mannheim
Saarland University Hospital
RECRUITING
Saarbrücken
Krankenhaus der Barmherzigen Brüder Trier
RECRUITING
Trier
Hungary
Semmelweis University
RECRUITING
Budapest
University of Debrecen
RECRUITING
Debrecen
Netherlands
Amsterdam University Medical Centre
RECRUITING
Amsterdam
Maastricht UMC+
RECRUITING
Maastricht
Poland
Jagiellonian University Hospital
RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
RECRUITING
Warsaw
Silesian Center for Heart Diseases
RECRUITING
Zabrze
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clínico de Barcelona
RECRUITING
Barcelona
La Paz University Hospital
RECRUITING
Madrid
Hospital Universitario Nuestra Señora de Candelaria
RECRUITING
Santa Cruz De Tenerife
United Kingdom
Royal Brompton
RECRUITING
London
St. Bartholomew's Hospital
RECRUITING
London
St. Thomas Hospital
RECRUITING
London
John Radcliffe Hospital
RECRUITING
Oxford
Southampton General Hospital
RECRUITING
Southhampton
Contact Information
Primary
Hans-Peter Stoll, MD, PhD
hpstoll@orchestrabiomed.com
646-956-2161
Backup
Angela Stagg
astagg@orchestrabiomed.com
Time Frame
Start Date: 2023-12-27
Estimated Completion Date: 2029-08
Participants
Target number of participants: 500
Treatments
Experimental: Treatment Group
AVIM therapy activated with continued stable antihypertensive drug therapy
Sham_comparator: Control Group
AVIM therapy deactivated with continued stable antihypertensive drug therapy
Related Therapeutic Areas
Sponsors
Leads: Orchestra BioMed, Inc
Collaborators: Medtronic