Status:
COMPLETED
Pacemaker Therapy for Drug-refractory Symptoms in Mid-cavity Hypertrophic Cardiomyopathy
Lead Sponsor:
Barts & The London NHS Trust
Conditions:
Cardiomyopathy, Hypertrophic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main aim of this study is to assess the acute effects of a pacemaker on reducing abnormally high intracavity pressures in the hearts of patients with mid-cavity obstructive hypertrophic cardiomyop...
Detailed Description
Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease, affecting 1 in 500 of the general population. It is characterised by abnormal thickening of the heart muscle. The various ...
Eligibility Criteria
Inclusion
- Male or female, \>18 years.
- Referred for PPM +/- ICD implantation for either primary prevention of sudden cardiac death or other indications such as heart block or obstructive physiology.
- HCM patients with evidence of mid-cavity gradient demonstrated by echocardiography and gradient ≥30 mmHg confirmed by cardiac catheterisation at rest or with isoprenaline provocation.
- All patients should be taking maximum tolerated doses of beta blockers or verapamil with or without disopyramide.
- Symptoms refractory to optimum medical therapy as above, for example breathlessness, chest pain, dizziness, or syncope.
Exclusion
- Patients with multi-level obstruction, i.e. across the mid-cavity and outflow tract.
- Patients with moderate or severe valvular stenosis or regurgitation.
- Patients with a history of myocardial infarction or acute coronary syndrome.
- Patients unable to provide informed consent.
- Patients in atrial fibrillation.
- Pregnancy.
- Renal failure.
- If considered unsuitable by clinician.
- Patients already participating in trials involving invasive procedures.
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03450252
Start Date
February 9 2018
End Date
January 20 2023
Last Update
February 1 2023
Active Locations (1)
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1
Barts Heart Centre
London, Thames, United Kingdom, EC1A 7BE