ELEVATE-HFpEF Clinical Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Study ID
NCT06678841
Status
Recruiting
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Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

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

Interventions

  • Personalized cardiac pacing — DEVICE
    Personalized cardiac pacing treatment based each patient's height and baseline LVEF.

Study Details

ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

Key Dates

Start date
Jul 9, 2025
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Feb 28, 2029

Study Design

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

Arms

  • Experimental: Personalized Pacing Therapy (Treatment Group)
    The treatment group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide dual chamber pacing at a personalized cardiac pacing rate determined by patient height and baseline LVEF percentage.
  • No Intervention: Control Group
    The control group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide ventricular pacing at a non-personalized rate. This is considered limited or backup pacing.

Primary Outcome Measure

Primary Efficacy Objective: Hierarchical composite endpoint of cardiovascular mortality, urgent HF events, HF events requiring an oral diuretic intensification (ODI), change in KCCQ, change in six-minute walk test distance, and change in NT-proBNP. [ Time Frame: Follow-up duration for endpoint analysis is 12-months. ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Banner - University Medical Center PhoenixPhoenixArizona85006-
Sutter Health HospitalSan FranciscoCalifornia94107-
Hartford HospitalHartfordConnecticut06106-
Cardiovascular Institute of Northwest FloridaPanama CityFlorida32405-
Emory UniversityAtlantaGeorgia30308-
The University of Chicago Medical CenterChicagoIllinois60637-
Norton HealthcareLouisvilleKentucky40295-
Cardiovascular Institute of the SouthHoumaLouisiana70360-
Tufts Medical CenterBostonMassachusetts02111-
M Health Fairview University of Minnesota Medical Center - East BankMinneapolisMinnesota55455-
Saint Lukes Mid America Heart InstituteKansas CityMissouri64111-
Duke University Medical CenterDurhamNorth Carolina27710-
Mount Carmel EastColumbusOhio43219-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Lancaster General HospitalLancasterPennsylvania17602-
Lankenau Institute for Medical ResearchWynnewoodPennsylvania19096-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
Saint Thomas Research InstituteNashvilleTennessee37203-
Dallas VA Medical CenterDallasTexas75216-
Texas Health Research & Education InstituteFort WorthTexas76104-
The University of Vermont Medical CenterBurlingtonVermont05401-
Inova Fairfax HospitalFalls ChurchVirginia22042-
Saint Joseph Medical Center (Tacoma WA)TacomaWashington98405-
Charleston Area Medical Center (CAMC) Memorial HospitalCharlestonWest Virginia25304-
Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By research site
Banner - University Medical Center Phoenix· Phoenix, AZSutter Health Hospital· San Francisco, CAHartford Hospital· Hartford, CTCardiovascular Institute of Northwest Florida· Panama City, FLEmory University· Atlanta, GAThe University of Chicago Medical Center· Chicago, IL

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