BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Orchestra BioMed, Inc
Study ID
NCT06059638
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated — DEVICE
    Antihypertensive therapy utilizing atrioventricular interval modulation.
  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated — DEVICE
    AVIM therapy is deactivated

Study Details

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.

Key Dates

Start date
Dec 27, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Aug 31, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    AVIM therapy activated with continued stable antihypertensive drug therapy
  • Sham Comparator: Control Group
    AVIM therapy deactivated with continued stable antihypertensive drug therapy

Primary Outcome Measure

Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months [ Time Frame: Baseline and 3 months post randomization ]

Central Contacts

Locations (70)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
Adventist Health GlendaleGlendaleCalifornia91206-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92633-
StanfordRedwood CityCalifornia94063-
Scripps ClinicSan DiegoCalifornia92121-
Sutter Valley HospitalsSan FranciscoCalifornia94109-
South Denver CardiologyDenverColorado80210-
Colorado Heart and VascularGoldenColorado80401-
Intermountain Health Lutheran HospitalGoldenColorado80401-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
HCA Florida JFK HospitalAtlantisFlorida33462-
Cardiovascular Research Solutions (MyCardiologist)CelebrationFlorida34747-
Clearwater Cardiovascular ConsultantsClearwaterFlorida33756-
Citrus Cardiology ConsultantsCrystal RiverFlorida34429-
The Cardiac and Vascular InstituteGainesvilleFlorida32605-
Memorial Healthcare SystemHollywoodFlorida33021-
Baptist Health JacksonvilleJacksonvilleFlorida32207-
Baptist Health South FloridaMiamiFlorida33176-
Mount Sinai Medical Center of FloridaMiami BeachFlorida33140-
Sarasota Memorial HospitalSarasotaFlorida34239-
Piedmont Healthcare, Inc.AtlantaGeorgia30309-
Wellstar Research InstituteMariettaGeorgia30060-
St. Luke's Idaho CardiologyBoiseIdaho83712-
University of ChicagoChicagoIllinois60637-
University of Kansas Medical CenterKansas CityKansas66160-
West Houston Area Clinical Trial Consultants (Wichita, KS)WichitaKansas67226-
Baptist Health LexingtonLexingtonKentucky40503-
Ochsner Medical CenterNew OrleansLouisiana70121-
Medstar Union Memorial HospitalBaltimoreMaryland21218-
The Johns Hopkins UniversityBaltimoreMaryland21205-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
St. Elizabeth's Medical CenterBostonMassachusetts02135-
The Brigham and Women's HospitalBostonMassachusetts02115-
Henry Ford HealthDetroitMichigan48202-2689-
UMH-Sparrow Clinical ResearchLansingMichigan48912-
Michigan HeartYpsilantiMichigan48197-
Health Partners Institute (Methodist Heart and Vascular Center)BloomingtonMinnesota55425-
Minneapolis Heart InstituteMinneapolisMinnesota55407-
Mayo ClinicRochesterMinnesota55905-
Washington University St. LouisSt LouisMissouri63130-
The Cooper Health SystemCamdenNew Jersey08103-
Hackensack University Medical CenterHackensackNew Jersey07601-
Virtua Medical Group, P.A.MarltonNew Jersey08053-
Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
The Valley HospitalRidgewoodNew Jersey07450-
Lovelace Medical Center (New Mexico Heart Institute)AlbuquerqueNew Mexico87110-
Northwell Health, Inc.New Hyde ParkNew York11042-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of Rochester - Cardiology CCTURochesterNew York14642-
HCA Asheville Cardiology AssociatesAshevilleNorth Carolina28801-
Atrium Health - Sanger HeartCharlotteNorth Carolina28210-
WakeMedRaleighNorth Carolina27610-
The Lindner Research CenterCincinnatiOhio45219-
OhioHealth CorporationColumbusOhio43214-
The Ohio State UniversityColumbusOhio43210-
Hightower Clinical TrialsOklahoma CityOklahoma73102-
South Oklahoma Heart ResearchOklahoma CityOklahoma73135-
University of OklahomaOklahoma CityOklahoma73019-
Penn Medicine at Doylestown Health CardiologyDoylestownPennsylvania18901-
Penn Medicine Lancaster General HealthLancasterPennsylvania17602-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Stern Cardiovascular Foundation, Inc.GermantownTennessee38138-
Ascension St. Thomas HospitalNashvilleTennessee37203-
Ascension SetonAustinTexas78723-
Baylor Scott & White Research InstituteDallasTexas75204-
Centra Health dba Stroobants Cardiovascular CenterLynchburgVirginia24501-
West Virginia UniversityMorgantownWest Virginia26506-
Advocate Aurora Research Institute, LLCMilwaukeeWisconsin53233-

Find similar trials in Scottsdale, AZ

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
HonorHealth· Scottsdale, AZAdventist Health Glendale· Glendale, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAStanford· Redwood City, CAScripps Clinic· San Diego, CASutter Valley Hospitals· San Francisco, CA

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