Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
10 participants
INTERVENTIONAL
2023-07-20
2025-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Routine Medical Therapy
Routine Medical Therapy
CRT-pacemaker device set to Routine Medical Therapy
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy
Routine Medical Therapy + LVP
Routine Medical Therapy + LVP
CRT-pacemaker device set to Routine Medical Therapy + LVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP
Routine Medical Therapy + BiVP
Routine Medical Therapy + BiVP
CRT-pacemaker device set to Routine Medical Therapy + BiVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP
Interventions
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CRT-pacemaker device set to Routine Medical Therapy
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy
CRT-pacemaker device set to Routine Medical Therapy + LVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP
CRT-pacemaker device set to Routine Medical Therapy + BiVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP
Eligibility Criteria
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Inclusion Criteria
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
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).
ALL
No
Sponsors
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Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
Cardiff Metropolitan University
OTHER
Cardiff and Vale University Health Board
OTHER_GOV
Responsible Party
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Principal Investigators
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Zaheer Yousef
Role: PRINCIPAL_INVESTIGATOR
Cardiff and Vale University Health Board
Locations
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University Hospital Wales
Cardiff, , United Kingdom
Countries
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Other Identifiers
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203878
Identifier Type: -
Identifier Source: org_study_id
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