Heart Failure
Conditions
Brief summary
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
Interventions
DEVICECRT-pacemaker device set to Routine Medical Therapy
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy
DEVICECRT-pacemaker device set to Routine Medical Therapy + LVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP
DEVICECRT-pacemaker device set to Routine Medical Therapy + BiVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Cardiff Metropolitan University
Cardiff and Vale University Health Board
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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). 2. 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. 3. Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography. 4. Adults (over 18 years) 5. Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation. 6. Two weeks or more following final dose of vaccination against coronavirus.
Exclusion criteria
1. Inability to provide informed consent. 2. Enrolment in other clinical studies. 3. BMI more than 35 4. Objective evidence of significant lung disease on formal lung function testing 5. Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery 6. Acute coronary syndrome (within the previous three months) 7. History of atrial fibrillation (AF) 8. Renal insufficiency requiring haemodialysis 9. Life expectancy less than 6 months 10. Prosthetic heart valves 11. Blood coagulation disorders 12. Immunocompromised patients (e.g. AIDS, patients on steroids, cytotoxic drugs, and radiation therapy) 13. Currently pregnant, or intending to conceive. 14. Recent positive Covid test (up to 14 days prior to pre-assessment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in LV area between rest and exercise across the three pacing states | 12 weeks |
| Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states | 12 weeks |
| Change in rest and exercise E/E' on echocardiography across the three pacing states | 12 weeks |
Countries
United Kingdom
Outcome results
None listed