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NCT06059638NARecruiting

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Orchestra BioMed, Inc

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

Inclusion Criteria: 1. 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 2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug 3. Office SBP ≥135 mmHg and \<180 mmHg 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg Exclusion Criteria: 1. LVEF \<50% 2. NYHA Class III-IV 3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months 4. Myocardial infarction (MI) within 3 months 5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months 6. Permanent atrial fibrillation 7. Mitral valve regurgitation greater than or equal to grade 3 8. Aortic stenosis with a valve area less than 1.5 cm2 9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy) 10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Interventions

DEVICE

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

DEVICE

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Interested in This Trial?

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Conditions

HypertensionHypertension, SystolicHypertension, Essential

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