Phase
Condition
Diabetes And Hypertension
High Blood Pressure (Hypertension - Pediatric)
Arrhythmia
Treatment
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performedwithin 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamberpacemaker system or at any time thereafter
On a stable antihypertension treatment regimen with at least 1 class ofantihypertensive drug
Office SBP ≥135 mmHg and <180 mmHg
Average 24-Hour aSBP ≥130 mmHg and <170 mmHg
Exclusion
Exclusion Criteria:
LVEF <50%
NYHA Class III-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 interventionwithin 3 months
Permanent atrial fibrillation
Mitral valve regurgitation greater than or equal to 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., renaldenervation procedure, baroreflex activation therapy)
Has an existing active cardiac device or neurostimulator other than the recentAstra/Azure pacemaker implant
Study Design
Study Description
Connect with a study center
OLV Hospital Aalst
Aalst,
BelgiumSite Not Available
OLV Ziekenhuis
Aalst,
BelgiumSite Not Available
OLV Ziekenhuis
Aalst 2803448,
BelgiumActive - Recruiting
Middelheim Ziekenhuis
Antwerp,
BelgiumSite Not Available
Middelheim Ziekenhuis
Antwerp 2803138,
BelgiumActive - Recruiting
UZ Brussel
Brussel,
BelgiumSite Not Available
Universite Libre de Bruxelles-Erasme Hospital
Brussels,
BelgiumSite Not Available
UZ Brussel
Brussels 2800866,
BelgiumActive - Recruiting
Universite Libre de Bruxelles-Erasme Hospital
Brussels 2800866,
BelgiumActive - Recruiting
UZ Leuven
Leuven,
BelgiumSite Not Available
UZ Leuven
Leuven 2792482,
BelgiumActive - Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague,
CzechiaSite Not Available
Na Homolce Hospital
Prague,
CzechiaActive - Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague 3067696,
CzechiaActive - Recruiting
Na Homolce Hospital
Prague 3067696,
CzechiaActive - Recruiting
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
Frankfurt,
GermanySite Not Available
Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
Frankfurt 2925536,
GermanyActive - Recruiting
University Medical Centre Mannheim
Mannheim,
GermanySite Not Available
University Medical Centre Mannheim
Mannheim 2873891,
GermanyActive - Recruiting
Saarland University Hospital
Saarbrücken,
GermanySite Not Available
Saarland University Hospital
Saarbrücken 2842647,
GermanyActive - Recruiting
Krankenhaus der Barmherzigen Brüder Trier
Trier,
GermanySite Not Available
Krankenhaus der Barmherzigen Brüder Trier
Trier 2821164,
GermanyActive - Recruiting
Semmelweis University
Budapest,
HungarySite Not Available
Semmelweis University
Budapest 3054643,
HungaryActive - Recruiting
University of Debrecen
Debrecen,
HungarySite Not Available
University of Debrecen
Debrecen 721472,
HungaryActive - Recruiting
Amsterdam University Medical Centre
Amsterdam,
NetherlandsSite Not Available
Amsterdam University Medical Centre
Amsterdam 2759794,
NetherlandsActive - Recruiting
Maastricht UMC+
Maastricht,
NetherlandsSite Not Available
Maastricht UMC+
Maastricht 2751283,
NetherlandsActive - Recruiting
Jagiellonian University Hospital
Krakow 3094802,
PolandActive - Recruiting
Jagiellonian University Hospital
Kraków,
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan,
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan 3088171,
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw,
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw 756135,
PolandActive - Recruiting
Silesian Center for Heart Diseases
Zabrze,
PolandSite Not Available
Silesian Center for Heart Diseases
Zabrze 3080985,
PolandActive - Recruiting
Hospital Germans Trias i Pujol
Badalona,
SpainSite Not Available
Hospital Germans Trias i Pujol
Badalona 3129028,
SpainActive - Recruiting
Hospital Clínico de Barcelona
Barcelona,
SpainSite Not Available
Hospital Clínico de Barcelona
Barcelona 3128760,
SpainActive - Recruiting
Hospital La Paz
Madrid,
SpainSite Not Available
La Paz University Hospital
Madrid,
SpainSite Not Available
La Paz University Hospital
Madrid 3117735,
SpainActive - Recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz De Tenerife,
SpainSite Not Available
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife 2511174,
SpainActive - Recruiting
Royal Brompton
London,
United KingdomActive - Recruiting
St. Bartholomew's Hospital
London,
United KingdomActive - Recruiting
St. Thomas Hospital
London,
United KingdomSite Not Available
Royal Brompton
London 2643743,
United KingdomActive - Recruiting
St. Bartholomew's Hospital
London 2643743,
United KingdomActive - Recruiting
St. Thomas Hospital
London 2643743,
United KingdomActive - Recruiting
John Radcliffe Hospital
Oxford,
United KingdomSite Not Available
John Radcliffe Hospital
Oxford 2640729,
United KingdomActive - Recruiting
Southampton General Hospital
Southhampton,
United KingdomActive - Recruiting
HonorHealth
Scottsdale, Arizona 85258
United StatesSite Not Available
HonorHealth
Scottsdale 5313457, Arizona 5551752 85258
United StatesActive - Recruiting
Stanford
Redwood City, California 94063
United StatesSite Not Available
Sutter Valley Hospitals
Sacramento, California 95816
United StatesSite Not Available
Scripps Clinic
San Diego, California 92121
United StatesSite Not Available
Sutter Valley Hospitals
San Francisco, California 94109
United StatesSite Not Available
Adventist Health Glendale
Glendale 5352423, California 5332921 91206
United StatesActive - Recruiting
Stanford
Redwood City 5386834, California 5332921 94063
United StatesActive - Recruiting
Scripps Clinic
San Diego 5391811, California 5332921 92121
United StatesActive - Recruiting
Sutter Valley Hospitals
San Francisco 5391959, California 5332921 94109
United StatesActive - Recruiting
Intermountain Health Lutheran Hospital
Golden 5423294, Colorado 5417618 80401
United StatesActive - Recruiting
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesActive - Recruiting
Clearwater Cardiovascular Consultants
Clearwater, Florida 33756
United StatesSite Not Available
Citrus Cardiology Consultants
Crystal River, Florida 34429
United StatesSite Not Available
Memorial Healthcare System
Hollywood, Florida 33021
United StatesSite Not Available
Baptist Health Jacksonville
Jacksonville, Florida 32207
United StatesSite Not Available
Baptist Health South Florida
Miami, Florida 33176
United StatesSite Not Available
Mount Sinai Medical Center of Florida
Miami Beach, Florida 33140
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
HCA Florida JFK Hospital
Atlantis 4146372, Florida 4155751 33462
United StatesActive - Recruiting
Cardiovascular Research Solutions (MyCardiologist)
Celebration 4150394, Florida 4155751 34747
United StatesActive - Recruiting
Clearwater Cardiovascular Consultants
Clearwater 4151316, Florida 4155751 33756
United StatesActive - Recruiting
Citrus Cardiology Consultants
Crystal River 4152487, Florida 4155751 34429
United StatesActive - Recruiting
Memorial Healthcare System
Hollywood 4158928, Florida 4155751 33021
United StatesActive - Recruiting
Baptist Health Jacksonville
Jacksonville 4160021, Florida 4155751 32207
United StatesActive - Recruiting
Baptist Health South Florida
Miami 4164138, Florida 4155751 33176
United StatesActive - Recruiting
Mount Sinai Medical Center of Florida
Miami Beach 4164143, Florida 4155751 33140
United StatesActive - Recruiting
Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
United StatesActive - Recruiting
Piedmont Healthcare, Inc.
Atlanta, Georgia 30309
United StatesSite Not Available
Piedmont Healthcare, Inc.
Atlanta 4180439, Georgia 4197000 30309
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas 67226
United StatesSite Not Available
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesActive - Recruiting
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita 4281730, Kansas 4273857 67226
United StatesActive - Recruiting
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503
United StatesActive - Recruiting
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Ochsner Medical Center
New Orleans 4335045, Louisiana 4331987 70121
United StatesActive - Recruiting
The Johns Hopkins University
Baltimore, Maryland 21205
United StatesSite Not Available
The Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21205
United StatesActive - Recruiting
St. Elizabeth's Medical Center
Boston, Massachusetts 02135
United StatesActive - Recruiting
The Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
St. Elizabeth's Medical Center
Boston 4930956, Massachusetts 6254926 02135
United StatesActive - Recruiting
The Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesActive - Recruiting
Henry Ford Health
Detroit, Michigan 48202-2689
United StatesSite Not Available
Michigan Heart
Ypsilanti, Michigan 48197
United StatesSite Not Available
Henry Ford Health
Detroit 4990729, Michigan 5001836 48202-2689
United StatesActive - Recruiting
UMH-Sparrow Clinical Research
Lansing 4998830, Michigan 5001836 48912
United StatesActive - Recruiting
Michigan Heart
Ypsilanti 5015688, Michigan 5001836 48197
United StatesActive - Recruiting
Health Partners Institute (Methodist Heart and Vascular Center)
Bloomington, Minnesota 55425
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Health Partners Institute (Methodist Heart and Vascular Center)
Bloomington 5018739, Minnesota 5037779 55425
United StatesActive - Recruiting
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Washington University St. Louis
Saint Louis, Missouri 63130
United StatesSite Not Available
Washington University St. Louis
St. Louis, Missouri 63130
United StatesSite Not Available
Washington University St. Louis
St Louis 4407066, Missouri 4398678 63130
United StatesActive - Recruiting
The Cooper Health System
Camden, New Jersey 08103
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Virtua Medical Group, P.A.
Marlton, New Jersey 08053
United StatesSite Not Available
The Valley Hospital
Ridgewood, New Jersey 07450
United StatesSite Not Available
The Cooper Health System
Camden 4501018, New Jersey 5101760 08103
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Virtua Medical Group, P.A.
Marlton 4502911, New Jersey 5101760 08053
United StatesActive - Recruiting
Jersey Shore University Medical Center
Neptune City 5101687, New Jersey 5101760 07753
United StatesActive - Recruiting
The Valley Hospital
Ridgewood 5103269, New Jersey 5101760 07450
United StatesTerminated
Lovelace Medical Center (New Mexico Heart Institute)
Albuquerque, New Mexico 87110
United StatesSite Not Available
Lovelace Medical Center (New Mexico Heart Institute)
Albuquerque 5454711, New Mexico 5481136 87110
United StatesActive - Recruiting
Northwell Health, Inc.
New Hyde Park, New York 11042
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Northwell Health, Inc.
New Hyde Park 5128514, New York 5128638 11042
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
WakeMed
Raleigh, North Carolina 27610
United StatesSite Not Available
HCA Asheville Cardiology Associates
Asheville 4453066, North Carolina 4482348 28801
United StatesActive - Recruiting
WakeMed
Raleigh 4487042, North Carolina 4482348 27610
United StatesActive - Recruiting
The Lindner Research Center
Cincinnati, Ohio 45219
United StatesSite Not Available
OhioHealth Corporation
Columbus, Ohio 43214
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
The Lindner Research Center
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
OhioHealth Corporation
Columbus 4509177, Ohio 5165418 43214
United StatesActive - Recruiting
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
University of Oklahoma
Oklahoma, Oklahoma 73019
United StatesSite Not Available
South Oklahoma Heart Research
Oklahoma City, Oklahoma 73135
United StatesSite Not Available
University of Oklahoma
Oklahoma City, Oklahoma 73019
United StatesActive - Recruiting
Hightower Clinical Trials
Oklahoma City 4544349, Oklahoma 4544379 73102
United StatesActive - Recruiting
South Oklahoma Heart Research
Oklahoma City 4544349, Oklahoma 4544379 73135
United StatesActive - Recruiting
University of Oklahoma
Oklahoma City 4544349, Oklahoma 4544379 73019
United StatesActive - Recruiting
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania 17602
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Penn Medicine Lancaster General Health
Lancaster 5197079, Pennsylvania 6254927 17602
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Penn Presbyterian Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesActive - Recruiting
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee 38138
United StatesSite Not Available
Ascension St. Thomas Hospital
Nashville, Tennessee 37203
United StatesSite Not Available
Stern Cardiovascular Foundation, Inc.
Germantown 4624601, Tennessee 4662168 38138
United StatesActive - Recruiting
Ascension St. Thomas Hospital
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Ascension Seton
Austin, Texas 78723
United StatesSite Not Available
Baylor Scott & White Research Institute
Dallas, Texas 75204
United StatesSite Not Available
Ascension Seton
Austin 4671654, Texas 4736286 78723
United StatesActive - Recruiting
Baylor Scott & White Research Institute
Dallas 4684888, Texas 4736286 75204
United StatesActive - Recruiting
Centra Health dba Stroobants Cardiovascular Center
Lynchburg 4771075, Virginia 6254928 24501
United StatesActive - Recruiting
West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
United StatesActive - Recruiting
Advocate Aurora Research Institute, LLC
Milwaukee, Wisconsin 53233
United StatesSite Not Available
Advocate Aurora Research Institute, LLC
Milwaukee 5263045, Wisconsin 5279468 53233
United StatesActive - Recruiting

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