BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
BACKBEAT
1 other identifier
interventional
500
15 countries
131
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Dec 2023
Longer than P75 for not_applicable hypertension
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
July 9, 2026
May 1, 2026
2.9 years
September 22, 2023
July 8, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Treatment Group
EXPERIMENTALAVIM therapy activated with continued stable antihypertensive drug therapy
Control Group
SHAM COMPARATORAVIM therapy deactivated with continued stable antihypertensive drug therapy
Interventions
Antihypertensive therapy utilizing atrioventricular interval modulation.
AVIM therapy is deactivated
Eligibility Criteria
You may qualify if:
- 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
- On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
- Office SBP ≥135 mmHg and \<180 mmHg
- Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg
You may not qualify if:
- 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 intervention within 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., renal denervation procedure, baroreflex activation therapy)
- Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orchestra BioMed, Inclead
- Medtroniccollaborator
Study Sites (131)
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
Related Publications (2)
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.
PMID: 34387126BACKGROUNDNeuzil 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.
PMID: 29275370BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Kandzari, MD
Piedmont Heart Institute
- PRINCIPAL INVESTIGATOR
Andrea Russo, MD
Cooper University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2023
First Posted
September 28, 2023
Study Start
December 27, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
August 1, 2029
Last Updated
July 9, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share