Phase
Condition
Cardiac Disease
Heart Defect
High Blood Pressure (Hypertension)
Treatment
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has or is indicated for a de novo dual chamber pacemaker. Patient informedconsent must be obtained within 30 days prior to a planned de novo implant of aMedtronic Astra/Azure dual chamber pacemaker system or up to 365 days after
On a stable antihypertension treatment regimen with 1, 2, or 3 classes ofantihypertensive drugs
Office SBP ≥140 mmHg and <180 mmHg
Average 24-Hour aSBP ≥130 mmHg and <170 mmHg
Exclusion
Exclusion Criteria:
LVEF <50%
NYHA Class II-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
Persistent or permanent atrial fibrillation
Mitral valve regurgitation greater than 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,
BelgiumActive - Recruiting
Middelheim Ziekenhuis
Antwerp,
BelgiumActive - Recruiting
UZ Brussel
Brussel,
BelgiumActive - Recruiting
Universite Libre de Bruxelles-Erasme Hospital
Brussels,
BelgiumActive - Recruiting
UZ Leuven
Leuven,
BelgiumActive - Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague,
CzechiaActive - Recruiting
Na Homolce Hospital
Prague,
CzechiaActive - Recruiting
University Medical Centre Mannheim
Mannheim,
GermanyActive - Recruiting
Semmelweis University
Budapest,
HungaryActive - Recruiting
University of Debrecen
Debrecen,
HungaryActive - Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan,
PolandActive - Recruiting
Silesian Center for Heart Diseases
Zabrze,
PolandActive - Recruiting
Hospital Germans Trias i Pujol
Badalona,
SpainActive - Recruiting
Hospital La Paz
Madrid,
SpainSite Not Available
La Paz University Hospital
Madrid,
SpainActive - Recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz De Tenerife,
SpainActive - Recruiting
Royal Brompton
London,
United KingdomActive - Recruiting
St. Bartholomew's Hospital
London,
United KingdomActive - Recruiting
St. Thomas Hospital
London,
United KingdomActive - Recruiting
John Radcliffe Hospital
Oxford,
United KingdomActive - Recruiting
Southampton General Hospital
Southhampton,
United KingdomActive - Recruiting
HonorHealth
Scottsdale, Arizona 85258
United StatesActive - Recruiting
Scripps Clinic
San Diego, California 92121
United StatesActive - Recruiting
Citrus Cardiology Consultants
Crystal River, Florida 34429
United StatesActive - Recruiting
Memorial Healthcare System
Hollywood, Florida 33021
United StatesActive - Recruiting
Baptist Health Jacksonville
Jacksonville, Florida 32207
United StatesActive - Recruiting
Baptist Health South Florida
Miami, Florida 33176
United StatesActive - Recruiting
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesActive - Recruiting
Piedmont Healthcare, Inc.
Atlanta, Georgia 30309
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas 67226
United StatesActive - Recruiting
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesActive - Recruiting
The Johns Hopkins University
Baltimore, Maryland 21205
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Washington University St. Louis
Saint Louis, Missouri 63130
United StatesActive - Recruiting
The Cooper Health System
Camden, New Jersey 08103
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Virtua Medical Group, P.A.
Marlton, New Jersey 08053
United StatesActive - Recruiting
The Valley Hospital
Ridgewood, New Jersey 07450
United StatesActive - Recruiting
Northwell Health, Inc.
New Hyde Park, New York 11042
United StatesActive - Recruiting
The Lindner Research Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
OhioHealth Corporation
Columbus, Ohio 43214
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
University of Oklahoma
Oklahoma City, Oklahoma 73019
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee 38138
United StatesActive - Recruiting
Ascension St. Thomas Hospital
Nashville, Tennessee 37203
United StatesActive - Recruiting
Baylor Scott & White Research Institute
Dallas, Texas 75204
United StatesActive - Recruiting
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