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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | AVIM therapy activated with continued stable antihypertensive drug therapy |
|
| Control Group | Sham Comparator | AVIM therapy deactivated with continued stable antihypertensive drug therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated | Device | Antihypertensive therapy utilizing atrioventricular interval modulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months | Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization | Baseline and 3 months post randomization |
| Freedom from Unanticipated Serious Adverse Device Effects (USADE) | Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months. | 3 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hans-Peter Stoll, MD, PhD | Contact | 646-956-2161 | hpstoll@orchestrabiomed.com | |
| Angela Stagg | Contact | astagg@orchestrabiomed.com |
| Name | Affiliation | Role |
|---|---|---|
| David Kandzari, MD | Piedmont Heart Institute | Principal Investigator |
| Andrea Russo, MD | Cooper University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Scottsdale | Arizona | 85258 | United States | |
| Adventist Health Glendale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34387126 | Background | Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13. | |
| 29275370 |
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| Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated | Device | AVIM therapy is deactivated |
|
| Recruiting |
| Glendale |
| California |
| 91206 |
| United States |
| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92633 | United States |
| Stanford | Recruiting | Redwood City | California | 94063 | United States |
| Scripps Clinic | Recruiting | San Diego | California | 92121 | United States |
| Sutter Valley Hospitals | Recruiting | San Francisco | California | 94109 | United States |
| South Denver Cardiology | Recruiting | Denver | Colorado | 80210 | United States |
| Colorado Heart and Vascular | Recruiting | Golden | Colorado | 80401 | United States |
| Intermountain Health Lutheran Hospital | Recruiting | Golden | Colorado | 80401 | United States |
| UCHealth Medical Center of the Rockies | Recruiting | Loveland | Colorado | 80538 | United States |
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| HCA Florida JFK Hospital | Recruiting | Atlantis | Florida | 33462 | United States |
| Cardiovascular Research Solutions (MyCardiologist) | Recruiting | Celebration | Florida | 34747 | United States |
| Clearwater Cardiovascular Consultants | Recruiting | Clearwater | Florida | 33756 | United States |
| Citrus Cardiology Consultants | Recruiting | Crystal River | Florida | 34429 | United States |
| The Cardiac and Vascular Institute | Recruiting | Gainesville | Florida | 32605 | United States |
| Memorial Healthcare System | Recruiting | Hollywood | Florida | 33021 | United States |
| Baptist Health Jacksonville | Recruiting | Jacksonville | Florida | 32207 | United States |
| Baptist Health South Florida | Recruiting | Miami | Florida | 33176 | United States |
| Mount Sinai Medical Center of Florida | Recruiting | Miami Beach | Florida | 33140 | United States |
| Sarasota Memorial Hospital | Recruiting | Sarasota | Florida | 34239 | United States |
| Piedmont Healthcare, Inc. | Recruiting | Atlanta | Georgia | 30309 | United States |
| Wellstar Research Institute | Recruiting | Marietta | Georgia | 30060 | United States |
| St. Luke's Idaho Cardiology | Recruiting | Boise | Idaho | 83712 | United States |
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| Cardiovascular Research Institute of Kansas | Recruiting | Wichita | Kansas | 67226 | United States |
| West Houston Area Clinical Trial Consultants (Wichita, KS) | Recruiting | Wichita | Kansas | 67226 | United States |
| Baptist Health Lexington | Recruiting | Lexington | Kentucky | 40503 | United States |
| Ochsner Medical Center | Recruiting | New Orleans | Louisiana | 70121 | United States |
| The Johns Hopkins University | Recruiting | Baltimore | Maryland | 21205 | United States |
| Medstar Union Memorial Hospital | Recruiting | Baltimore | Maryland | 21218 | United States |
| The Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| St. Elizabeth's Medical Center | Recruiting | Boston | Massachusetts | 02135 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202-2689 | United States |
| UMH-Sparrow Clinical Research | Recruiting | Lansing | Michigan | 48912 | United States |
| Michigan Heart | Recruiting | Ypsilanti | Michigan | 48197 | United States |
| Health Partners Institute (Methodist Heart and Vascular Center) | Recruiting | Bloomington | Minnesota | 55425 | United States |
| Minneapolis Heart Institute | Recruiting | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Washington University St. Louis | Recruiting | St Louis | Missouri | 63130 | United States |
| The Cooper Health System | Recruiting | Camden | New Jersey | 08103 | United States |
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Virtua Medical Group, P.A. | Recruiting | Marlton | New Jersey | 08053 | United States |
| Jersey Shore University Medical Center | Recruiting | Neptune City | New Jersey | 07753 | United States |
| The Valley Hospital | Terminated | Ridgewood | New Jersey | 07450 | United States |
| Lovelace Medical Center (New Mexico Heart Institute) | Recruiting | Albuquerque | New Mexico | 87110 | United States |
| Northwell Health, Inc. | Withdrawn | New Hyde Park | New York | 11042 | United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| University of Rochester - Cardiology CCTU | Not yet recruiting | Rochester | New York | 14642 | United States |
| HCA Asheville Cardiology Associates | Recruiting | Asheville | North Carolina | 28801 | United States |
| Atrium Health - Sanger Heart | Recruiting | Charlotte | North Carolina | 28210 | United States |
| WakeMed | Recruiting | Raleigh | North Carolina | 27610 | United States |
| The Lindner Research Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
| OhioHealth Corporation | Recruiting | Columbus | Ohio | 43214 | United States |
| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73019 | United States |
| Hightower Clinical Trials | Recruiting | Oklahoma City | Oklahoma | 73102 | United States |
| South Oklahoma Heart Research | Recruiting | Oklahoma City | Oklahoma | 73135 | United States |
| Penn Medicine at Doylestown Health Cardiology | Recruiting | Doylestown | Pennsylvania | 18901 | United States |
| Penn Medicine Lancaster General Health | Recruiting | Lancaster | Pennsylvania | 17602 | United States |
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| Stern Cardiovascular Foundation, Inc. | Recruiting | Germantown | Tennessee | 38138 | United States |
| Ascension St. Thomas Hospital | Recruiting | Nashville | Tennessee | 37203 | United States |
| Ascension Seton | Recruiting | Austin | Texas | 78723 | United States |
| Baylor Scott & White Research Institute | Recruiting | Dallas | Texas | 75204 | United States |
| Centra Health dba Stroobants Cardiovascular Center | Recruiting | Lynchburg | Virginia | 24501 | United States |
| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
| Advocate Aurora Research Institute, LLC | Recruiting | Milwaukee | Wisconsin | 53233 | United States |
| Lyell McEwin Hospital | Not yet recruiting | Elizabeth Vale | South Australia | 5112 | Australia |
| OLV Ziekenhuis | Recruiting | Aalst | Belgium |
| Middelheim Ziekenhuis | Recruiting | Antwerp | Belgium |
| Universite Libre de Bruxelles-Erasme Hospital | Recruiting | Brussels | Belgium |
| UZ Brussel | Recruiting | Brussels | Belgium |
| UZ Leuven | Recruiting | Leuven | Belgium |
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
| Fakultní nemocnice Královské Vinohrady (FNKV) | Recruiting | Prague | Czechia |
| Institute for Clinical and Experimental Medicine (IKEM) | Recruiting | Prague | Czechia |
| Na Homolce Hospital | Recruiting | Prague | Czechia |
| CHU Grenoble | Recruiting | Grenoble | France |
| Hospices Civils de Lyon (HCL) | Recruiting | Lyon | France |
| CHU de Nantes | Recruiting | Nantes | France |
| AP-HP Hôpital Pitié Salpêtrière | Recruiting | Paris | France |
| CHRU Tours | Recruiting | Tours | France |
| Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC) | Recruiting | Berlin | Germany |
| Herzzentrum Bonn am Universitätsklinikum Bonn | Recruiting | Bonn | Germany |
| Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus | Recruiting | Frankfurt | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
| Herzzentrum Leipzig | Not yet recruiting | Leipzig | Germany |
| University Hospital Luebeck | Recruiting | Lübeck | Germany |
| University Medical Centre Mannheim | Recruiting | Mannheim | Germany |
| Saarland University Hospital | Recruiting | Saarbrücken | Germany |
| Krankenhaus der Barmherzigen Brüder Trier | Recruiting | Trier | Germany |
| Central Hospital of Northern Pest - Military Hospital | Recruiting | Budapest | Hungary |
| Semmelweis University | Recruiting | Budapest | Hungary |
| University of Debrecen | Recruiting | Debrecen | Hungary |
| University of Szeged | Recruiting | Szeged | Hungary |
| Policlinico Di Sant Orsola Malpighi | Recruiting | Bologna | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Not yet recruiting | Milan | Italy |
| Campus Bio-Medico University Hospital | Recruiting | Rome | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Recruiting | Verona | Italy |
| IRCCS Sacro Cuore Don Calabria | Recruiting | Verona | Italy |
| Amsterdam University Medical Centre | Recruiting | Amsterdam | Netherlands |
| Maastricht UMC+ | Recruiting | Maastricht | Netherlands |
| Isala Klinieken | Recruiting | Zwolle | Netherlands |
| ChristChurch Hospital | Not yet recruiting | Christchurch | Canterbury | 8140 | New Zealand |
| Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach | Recruiting | Katowice | Poland |
| Jagiellonian University Hospital | Recruiting | Krakow | Poland |
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Not yet recruiting | Lodz | Poland |
| Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego | Recruiting | Lublin | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Recruiting | Poznan | Poland |
| Uniwersytecki Szpital Kliniczny nr 2 PUM | Recruiting | Szczecin | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Recruiting | Warsaw | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu | Recruiting | Wroclaw | Poland |
| Silesian Center for Heart Diseases | Recruiting | Zabrze | Poland |
| Hospital Germans Trias i Pujol | Recruiting | Badalona | Spain |
| Hospital Clínico de Barcelona | Recruiting | Barcelona | Spain |
| La Paz University Hospital | Recruiting | Madrid | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Recruiting | Santa Cruz de Tenerife | Spain |
| Universitaetsspital Basel | Recruiting | Basel | Switzerland |
| Universitaetsspital Bern | Recruiting | Bern | Switzerland |
| Hôpitaux Universitaires de Genève | Recruiting | Geneva | Switzerland |
| Cardiocentro Ticino Lugano | Recruiting | Lugano | Switzerland |
| Royal Brompton | Recruiting | London | United Kingdom |
| St. Bartholomew's Hospital | Recruiting | London | United Kingdom |
| St. Thomas Hospital | Recruiting | London | United Kingdom |
| John Radcliffe Hospital | Recruiting | Oxford | United Kingdom |
| Southampton General Hospital | Recruiting | Southhampton | United Kingdom |
| Background |
| Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000092244 | Isolated Systolic Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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