NCT03215849Completed
Pacing in Heart Failure With Preserved LVEF
The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes. The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board \[CVUHB\]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography. All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order: Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 22 Jun 2017
- Start date
- 20 Jul 2023
- Primary completion date
- 3 Jul 2025
- Lead sponsor
- Cardiff and Vale University Health Board
- Diseases
- Heart failure
- NCT number
- NCT03215849
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 20 Jul 2023 to the primary completion date, 3 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery
- Acute coronary syndrome (within the previous three months)
- Immunocompromised patients (e.g. AIDS, patients on steroids, cytotoxic drugs, and radiation therapy)
- Recent positive Covid test (up to 14 days prior to pre-assessment).
Other illness
- Objective evidence of significant lung disease on formal lung function testing
- History of atrial fibrillation (AF)
- Renal insufficiency requiring haemodialysis
- Prosthetic heart valves
- Blood coagulation disorders
Other
- Inability to provide informed consent.
- Enrolment in other clinical studies.
- BMI more than 35
- Life expectancy less than 6 months
- Currently pregnant, or intending to conceive.
Who the study is looking for
- Clinical features consistent with heart failure. All patients will have symptoms of moderate to severe heart failure with New York Heart Association (NHYA) classification III or IV symptoms (for at least 3 months).
- LV Ejection Fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction.
- Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
- Adults (over 18 years)
- Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
- Two weeks or more following final dose of vaccination against coronavirus.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.