At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Personalized cardiac pacing (device)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- Personalized cardiac pacing — device: Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Medtronic Cardiac Rhythm and Heart Failure, is looking at people aged 40 or over with a type of heart failure where the heart's pumping squeeze is normal but the heart is still stiff (called HFpEF, or heart failure with preserved ejection fraction). The study involves the heart's natural rate compared with a personalised cardiac pacing rate.
Who can take part
- Age 40 or over
- Heart pumping measurement (ejection fraction) of 50% or more, recorded in the past 12 months
- Heart failure defined in the study way - for example, a worsening heart failure episode or hospital visit in the past 12 months, OR breathlessness on exertion with at least one extra sign such as fluid on the lungs, raised NT-proBNP blood test, certain heart pressure or heart scan findings
- On stable, guideline-recommended heart failure medicine for at least 30 days
- Average heart rate on a baseline heart monitor at least 5 beats per minute lower than the study's calculated personalised pacing rate
- Able and willing to follow the study plan, including walking independently at the start
Who may not be able to
- Heart pumping that has improved or recovered from below 50%
- Having, or being due to have, a pacemaker, defibrillator or cardiac resynchronisation device
- Currently pregnant
- Average heart rate under 50 beats per minute, or a slow heart rate causing symptoms
- Heart attack, heart surgery or urgent heart procedures in the past 3 months, or a planned heart procedure in the past 30 days
- Currently very unwell with heart failure needing intravenous drugs
- Body mass index (BMI) over 45
- Long-standing atrial fibrillation (an irregular heart rhythm) with a very slow heart rate or pauses
- Planned atrial fibrillation ablation procedure
- Certain heart muscle conditions such as amyloidosis, sarcoidosis or hypertrophic cardiomyopathy
- Uncontrolled high blood pressure (above 160/100 mmHg)
- Advanced kidney disease (stage 4 or worse)
- More than moderate heart valve disease
- Serious lung disease needing oxygen at home
- Known reason why a pacemaker cannot be fitted
- Other serious illness with life expectancy under 1 year
- Currently in another drug or device trial (unless pre-approved by the Medtronic Study Manager)
- A vulnerable adult who cannot give consent
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 40 Years and over
- Who
- All
- Number of participants
- 700
- Started
- 2025-07-09
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure with preserved ejection fraction (hfpef)
- • NA - 700 participants
- • 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)
Who can take part?
- • Ages 40 Years and over
- • Diagnosed with heart failure with preserved ejection fraction (hfpef)
Where?
- • Leeds - The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
- • London - Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital
- • Manchester - Manchester University NHS Foundation Trust - Manchester Royal Infirmary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group). Subjects will complete 2-month, 6-month, and 12-month visits where data will be collected. At the 12-month visit, the second group (control group) will also be programmed to their personalized cardiac pacing rate. Subjects will complete 14-month, 18-month, and 24-month visits where data will be collected. Following the 24-month visit, additional long-term follow-up visits will occur annually until study completion. The estimated study duration is approximately 4.5 years representing an estimated 24-month enrollment period and 18-month follow-up period.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Age ≥ 40 years
- ✓Documented EF ≥50% within the preceding 12 months
- ✓HFpEF defined as:
- ✓Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous...
- ✓Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING...
Who cannot take part
- ✗Improved or recovered EF (i.e., prior LVEF\<50%)
- ✗Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
- ✗Average heart rate \<50 bpm or causing symptoms bradycardia
- ✗Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
- ✗Severe obesity defined as BMI \>45.
See the full criteria
Where Is This Study? (3 UK sites)
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital
London SE1 7EH, United Kingdom
Manchester University NHS Foundation Trust - Manchester Royal Infirmary
Manchester M13 9WL, United Kingdom
How to Get in Touch
Dawn Dyer
Sponsor contactCONTACT
