Recruiting
Not applicable
ELEVATE-HFpEF Clinical Study
Condition(s) studied
Heart Failure With Preserved Ejection Fraction (HFpEF)
Investigational drug(s) / intervention(s)
Personalized cardiac pacing
Personalized cardiac pacing: Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Study summary
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).
Eligibility
Inclusion Criteria:
1. Age ≥ 40 years
2. Documented EF ≥50% within the preceding 12 months
3. HFpEF defined as:
1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR
2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
* Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure
* Elevated NT-proBNP in the last year defined as \>400 pg/m for patients with no AF or paroxysmal AF, or \>900 pg/ml for patients with ≥persistent AF
* Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)
* Echo criteria defined by ≥2 of:
* LV wall thickness ≥ 12 mm
* LV mass index (BSA indexed LVH): sex at birth male \>115 g/m2, sex at birth female \>95 g/m2
* Relative wall thickness ≥0.42
* E/e' ≥15 in sinus rhythm (or \> 11 in the setting of atrial fibrillation) OR septal \<7 cm/s or lateral e' \<10cm/s
* Tricuspid regurgitation (TR) velocity \>2.8 m/s
* Left atrial (LA) enlargement, defined by LA volume index \>34 ml/m2
4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)
6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).
Exclusion Criteria:
1. Improved or recovered EF (i.e., prior LVEF\<50%)
2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))
3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
4. Average heart rate \<50 bpm or symptomatic bradycardia
5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.
6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
7. Severe obesity defined as BMI \>45.
8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds
9. Planned AF ablation
10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
11. Hypertrophic cardiomyopathies
12. Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
13. End Stage Renal Disease (CKD 4 or greater)
14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
15. Significant primary pulmonary disease on home oxygen
16. Known contraindication for a pacemaker implant
17. Advanced co-morbidity with life expectancy \< 1 year
18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.
19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).
Primary outcome measure(s)
- 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. — Follow-up duration for endpoint analysis is 12-months.
Cardiovascular mortality, urgent heart failure events, and ODI heart failure events will be collected as they occur. The Kansas City Cardiomyopathy Questionnaire (KCCQ); (range of score is 0 to 100), 6-minute walk test (distance in meters), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) (picograms per milliliter, pg/mL) will be collected at Baseline and the 12-months visit. Treatment and control groups will be compared using a win ratio.
- Primary Safety Objective: Percentage of patients with major complications related to the system or procedure. — 12-months post pacemaker implant attempt.
Adverse events will be collected as they occur. Adverse events will be adjudicated for their relationship to the implant procedure and system. Severity of adverse events related to the procedure or system will be reviewed to determine if they are major complications. Major complications are defined as complications related to the system or procedure that result in one or more of the following: death, hospitalization, prolonged hospitalization by at least 48 hours, additional surgical intervention, system modification (e.g., reposition, replacement, or explant), and/or permanent loss of device function due to mechanical or electrical dysfunction of the device. The percentage of patients undergoing a pacemaker implant attempt who experience a major complication related to the system or procedure at 12 months.
Trial sites (50)
| Facility | City | Region | Status |
| Banner - University Medical Center Phoenix |
Phoenix |
Arizona |
Recruiting |
| Sutter Health Hospital |
San Francisco |
California |
Recruiting |
| Hartford Hospital |
Hartford |
Connecticut |
Recruiting |
| Cardiovascular Institute of Northwest Florida |
Panama City |
Florida |
Recruiting |
| Emory University |
Atlanta |
Georgia |
Recruiting |
| The University of Chicago Medical Center |
Chicago |
Illinois |
Recruiting |
| University of Kansas Medical Center |
Kansas City |
Kansas |
Recruiting |
| Norton Healthcare |
Louisville |
Kentucky |
Recruiting |
| Cardiovascular Institute of the South |
Houma |
Louisiana |
Recruiting |
| Tufts Medical Center |
Boston |
Massachusetts |
Recruiting |
| M Health Fairview University of Minnesota Medical Center - East Bank |
Minneapolis |
Minnesota |
Recruiting |
| Saint Lukes Mid America Heart Institute |
Kansas City |
Missouri |
Recruiting |
| Duke University Medical Center |
Durham |
North Carolina |
Recruiting |
| The Ohio State University Wexner Medical Center |
Columbus |
Ohio |
Recruiting |
| Mount Carmel East |
Columbus |
Ohio |
Recruiting |
| Lancaster General Hospital |
Lancaster |
Pennsylvania |
Recruiting |
| Lankenau Institute for Medical Research |
Wynnewood |
Pennsylvania |
Recruiting |
| Medical University of South Carolina (MUSC) |
Charleston |
South Carolina |
Recruiting |
| Saint Thomas Research Institute |
Nashville |
Tennessee |
Recruiting |
| Dallas VA Medical Center |
Dallas |
Texas |
Recruiting |
| Texas Health Research & Education Institute |
Fort Worth |
Texas |
Recruiting |
| The University of Vermont Medical Center |
Burlington |
Vermont |
Recruiting |
| Inova Fairfax Hospital |
Falls Church |
Virginia |
Recruiting |
| Saint Joseph Medical Center (Tacoma WA) |
Tacoma |
Washington |
Recruiting |
| Charleston Area Medical Center (CAMC) Memorial Hospital |
Charleston |
West Virginia |
Recruiting |
| Froedtert Hospital |
Milwaukee |
Wisconsin |
Recruiting |
| The Prince Charles Hospital |
Chermside |
Queensland |
Recruiting |
| The Alfred Hospital |
Melbourne |
Victoria |
Recruiting |
| Ordensklinikum Linz GmbH / Elisabethinen |
Linz |
Austria |
Recruiting |
| Universitair Ziekenhuis Antwerpen |
Edegem |
Belgium |
Recruiting |
| University of Calgary |
Calgary |
Canada |
Recruiting |
| Saint Pauls Hospital |
Vancouver |
Canada |
Recruiting |
| Fakultni nemocnice Královské Vinohrady |
Prague |
Czechia |
Recruiting |
| Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz |
Besançon |
France |
Recruiting |
| Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied |
Clermont-Ferrand |
France |
Recruiting |
| CHU Toulouse - Hôpital Rangueil |
Toulouse |
France |
Recruiting |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck |
Lübeck |
Germany |
Recruiting |
| Prince of Wales Hospital |
Hong Kong |
Hong Kong |
Recruiting |
| Queen Elizabeth Hospital (Hong Kong) |
Hong Kong |
Hong Kong |
Recruiting |
| Chiba University Hospital |
Chiba |
Chiba |
Recruiting |
+ 10 more sites — see the full list on the official registry below.
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