Clinical trial NCT06059638: BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Official title: BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Hypertension, Systolic
Hypertension, Essential
Lead sponsor: Orchestra BioMed, Inc
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2023-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 who are scheduled to undergo implantation of a, or already have an implanted, de novo Astra/Azure pacemaker system, who also have uncontrolled hypertension may be screened for inclusion into this study. All eligible subjects will receive the AVIM RAMware 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: Inclusion Criteria:

1. Patient has or is indicated for a de novo dual chamber pacemaker. Patient informed consent must be obtained within 30 days prior to a planned de novo implant of a Medtronic Astra/Azure dual chamber pacemaker system or up to 365 days after
2. On a stable antihypertension treatment regimen with 1, 2, or 3 classes of antihypertensive drugs
3. Office SBP ≥140 mmHg and \<180 mmHg
4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg

Exclusion Criteria:

1. LVEF \<50%
2. NYHA Class II-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. Persistent or permanent atrial fibrillation
7. Mitral valve regurgitation greater than 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

Primary outcomes:
measure: Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
timeFrame: Baseline and 3 months post randomization
measure: Freedom from Unanticipated Serious Adverse Device Effects (USADE)
timeFrame: 3 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Redwood City
country: United States
facility: Stanford
state: California
city: San Diego
country: United States
facility: Scripps Clinic
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Crystal River
country: United States
facility: Citrus Cardiology Consultants
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center of Florida
state: Florida
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare, Inc.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: West Houston Area Clinical Trial Consultants (Wichita, KS)
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University St. Louis
state: Missouri
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Marlton
country: United States
facility: Virtua Medical Group, P.A.
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New Hyde Park
country: United States
facility: Northwell Health, Inc.
state: New York
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Corporation
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: Lancaster
country: United States
facility: Penn Medicine Lancaster General Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Ascension St. Thomas Hospital
state: Tennessee
city: Austin
country: United States
facility: Ascension Seton
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Milwaukee
country: United States
facility: Advocate Aurora Research Institute, LLC
state: Wisconsin
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Antwerp
country: Belgium
facility: Middelheim Ziekenhuis
city: Brussels
country: Belgium
facility: Universite Libre de Bruxelles-Erasme Hospital
city: Brussel
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
city: Budapest
country: Hungary
facility: Semmelweis University
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centre
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Warsaw
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: La Paz University Hospital
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: London
country: United Kingdom
facility: Royal Brompton
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Southhampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Piedmont Heart Institute
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cooper University
name: Andrea Russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.