BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Start Date
12/27/2023
Completion Date
8/1/2029
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 scheduled for implantation of an Astra/Azure pacemaker, or those who already have one implanted, who also have hypertension, may be screened for inclusion into this study. Subjects meeting randomization eligibility criteria will have the investigational AVIM Therapy RAMware downloaded into the Astra/Azure pacemaker and be randomized 1:1 to either have AVIM therapy turned ON or turned OFF. All subjects will continue to receive antihypertensive drug therapy.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Conditions
Locations
HonorHealth
Scottsdale, Arizona 85258
United States
Adventist Health Glendale
Glendale, California 91206
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92633
United States
Stanford
Redwood City, California 94063
United States
Scripps Clinic
San Diego, California 92121
United States
Sutter Valley Hospitals
San Francisco, California 94109
United States
South Denver Cardiology
Denver, Colorado 80210
United States
Colorado Heart and Vascular
Golden, Colorado 80401
United States
Intermountain Health Lutheran Hospital
Golden, Colorado 80401
United States
UCHealth Medical Center of the Rockies
Loveland, Colorado 80538
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
HCA Florida JFK Hospital
Atlantis, Florida 33462
United States
Cardiovascular Research Solutions (MyCardiologist)
Celebration, Florida 34747
United States
Clearwater Cardiovascular Consultants
Clearwater, Florida 33756
United States
Citrus Cardiology Consultants
Crystal River, Florida 34429
United States
The Cardiac and Vascular Institute
Gainesville, Florida 32605
United States
Memorial Healthcare System
Hollywood, Florida 33021
United States
Baptist Health Jacksonville
Jacksonville, Florida 32207
United States
Baptist Health South Florida
Miami, Florida 33176
United States
Mount Sinai Medical Center of Florida
Miami Beach, Florida 33140
United States
Sarasota Memorial Hospital
Sarasota, Florida 34239
United States
Piedmont Healthcare, Inc.
Atlanta, Georgia 30309
United States
Wellstar Research Institute
Marietta, Georgia 30060
United States
St. Luke's Idaho Cardiology
Boise, Idaho 83712
United States
University of Chicago
Chicago, Illinois 60637
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas 67226
United States
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas 67226
United States
Baptist Health Lexington
Lexington, Kentucky 40503
United States
Ochsner Medical Center
New Orleans, Louisiana 70121
United States
The Johns Hopkins University
Baltimore, Maryland 21205
United States
Medstar Union Memorial Hospital
Baltimore, Maryland 21218
United States
The Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
St. Elizabeth's Medical Center
Boston, Massachusetts 02135
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Henry Ford Health
Detroit, Michigan 48202-2689
United States
UMH-Sparrow Clinical Research
Lansing, Michigan 48912
United States
Michigan Heart
Ypsilanti, Michigan 48197
United States
Health Partners Institute (Methodist Heart and Vascular Center)
Bloomington, Minnesota 55425
United States
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Washington University St. Louis
St Louis, Missouri 63130
United States
The Cooper Health System
Camden, New Jersey 08103
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Virtua Medical Group, P.A.
Marlton, New Jersey 08053
United States
Jersey Shore University Medical Center
Neptune City, New Jersey 07753
United States
The Valley Hospital
Ridgewood, New Jersey 07450
United States
Lovelace Medical Center (New Mexico Heart Institute)
Albuquerque, New Mexico 87110
United States
Northwell Health, Inc.
New Hyde Park, New York 11042
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
University of Rochester - Cardiology CCTU
Rochester, New York 14642
United States
HCA Asheville Cardiology Associates
Asheville, North Carolina 28801
United States
Atrium Health - Sanger Heart
Charlotte, North Carolina 28210
United States
WakeMed
Raleigh, North Carolina 27610
United States
The Lindner Research Center
Cincinnati, Ohio 45219
United States
The Ohio State University
Columbus, Ohio 43210
United States
OhioHealth Corporation
Columbus, Ohio 43214
United States
University of Oklahoma
Oklahoma City, Oklahoma 73019
United States
Hightower Clinical Trials
Oklahoma City, Oklahoma 73102
United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma 73135
United States
Penn Medicine at Doylestown Health Cardiology
Doylestown, Pennsylvania 18901
United States
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania 17602
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee 38138
United States
Ascension St. Thomas Hospital
Nashville, Tennessee 37203
United States
Ascension Seton
Austin, Texas 78723
United States
Baylor Scott & White Research Institute
Dallas, Texas 75204
United States
Centra Health dba Stroobants Cardiovascular Center
Lynchburg, Virginia 24501
United States
West Virginia University
Morgantown, West Virginia 26506
United States
Advocate Aurora Research Institute, LLC
Milwaukee, Wisconsin 53233
United States
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
Australia
OLV Ziekenhuis
Aalst,
Belgium
Middelheim Ziekenhuis
Antwerp,
Belgium
Universite Libre de Bruxelles-Erasme Hospital
Brussels,
Belgium
UZ Brussel
Brussels,
Belgium
UZ Leuven
Leuven,
Belgium
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
China
Fakultní nemocnice Královské Vinohrady (FNKV)
Prague,
Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague,
Czechia
Na Homolce Hospital
Prague,
Czechia
CHU Grenoble
Grenoble,
France
Hospices Civils de Lyon (HCL)
Lyon,
France
CHU de Nantes
Nantes,
France
AP-HP Hôpital Pitié Salpêtrière
Paris,
France
CHRU Tours
Tours,
France
Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)
Berlin,
Germany
Herzzentrum Bonn am Universitätsklinikum Bonn
Bonn,
Germany
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
Frankfurt,
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg,
Germany
Herzzentrum Leipzig
Leipzig,
Germany
University Hospital Luebeck
Lübeck,
Germany
University Medical Centre Mannheim
Mannheim,
Germany
Saarland University Hospital
Saarbrücken,
Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier,
Germany
Central Hospital of Northern Pest - Military Hospital
Budapest,
Hungary
Semmelweis University
Budapest,
Hungary
University of Debrecen
Debrecen,
Hungary
University of Szeged
Szeged,
Hungary
Policlinico Di Sant Orsola Malpighi
Bologna,
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan,
Italy
Campus Bio-Medico University Hospital
Rome,
Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona,
Italy
IRCCS Sacro Cuore Don Calabria
Verona,
Italy
Amsterdam University Medical Centre
Amsterdam,
Netherlands
Maastricht UMC+
Maastricht,
Netherlands
Isala Klinieken
Zwolle,
Netherlands
ChristChurch Hospital
Christchurch, Canterbury 8140
New Zealand
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice,
Poland
Jagiellonian University Hospital
Krakow,
Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz,
Poland
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
Lublin,
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan,
Poland
Uniwersytecki Szpital Kliniczny nr 2 PUM
Szczecin,
Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw,
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw,
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
Universitaetsspital Basel
Basel,
Switzerland
Universitaetsspital Bern
Bern,
Switzerland
Hôpitaux Universitaires de Genève
Geneva,
Switzerland
Cardiocentro Ticino Lugano
Lugano,
Switzerland
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