Pacemaker therapy for HCM
Distal ventricular pacing and intraventricular gradient reduction for symptomatic relief in drug-refractory hypertrophic cardiomyopathy patients with mid-cavity obstruction.
Trial Objective: To test the efficacy of distal ventricular pacing for pressure gradient reduction across the site of mid-cavity obstruction.
Disease area: Cardiomyopathy
Status: Actively recruiting
Chief Investigator: Sam Mohiddin
Sponsor: Barts Health NHS Trust
Funder: NIHR - Fellowship Award
NCT Ref: ClinicalTrials.gov Identifier: NCT03450252
There are currently very few treatment options beyond taking medicine for inherited cardiomyopathy, which may not help in reducing symptoms. We have developed a new technique which uses a cardiac pacemaker to try to reduce obstruction and abnormally high pressures within the heart and think this may relieve symptoms. We want to test whether the pacemaker can reduce the abnormally high pressures within the heart.
We know, from a group of patients who have already had this experimental procedure, that it improves some patients’ symptoms a lot, other patients’ not so much, and some patients’ not at all. Because of this, we need to see if there is a benefit to the patient from having the pacemaker set up in a certain way.
Patients taking part in the Pacemaker in HCM study will experience both a treatment period (active pacing) and a non-treatment period (back-up pacing). We do not know which treatment method is generally better, which is why we are conducting the study. Once the patient has experienced both settings, we can compare how they felt. At the end of the 12 months, the patient will confirm which of the two six month periods they felt better in. The doctor will then reveal to the patient which 6 months was the active pacing and which was the back-up pacing.
Sample size and duration
25 patients, taking place at the Barts Heart Centre, London over a 12-month period.
Dr Sam Mohiddin
Dr James Malcolmson
Telephone: +44(0) 7816170672