Electromechanically Optimised Right Ventricular Pacing In Hypertrophic Cardiomyopathy (EMORI-HCM)

Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hypertrophic Obstructive Cardiomyopathy (HOCM) is an inherited cardiac condition which causes the heart muscle to become abnormally thick causing obstruction of blood flow in the heart. This causes debilitating symptoms including shortness of breath, blackouts and chest pain. Current treatments are not ideal as the medication is often poorly tolerated or ineffective. People with HOCM can often have an Implantable Cardioverter Defibrillator (ICD) to shock them out of dangerous arrhythmias. ICD's can also be used as pacemakers and are a promising treatment option, since they can alter the sequence of the heart muscle contraction thereby relieving the obstruction to the blood flow, making it easier for the heart to pump. The study will recruit patients who already have an ICD/pacemaker or who are scheduled to have an ICD / pacemaker implanted. For patients who are due to have a device implanted high precision haemodynamic, echocardiographic and electrical measurement techniques will be used to assess whether adjusting the position of the pacing lead (at the time of implant) can bring about changes in LVOT gradient and blood pressure. These patients with a new device and also patients who already have a device in situ will then go on to have atrioventricular delay (AV Delay) optimisation so we can assess what the optimum AV delay should be programmed at in order to bring about the most improvement in LVOT gradient and blood pressure. Patients will then be recruited into a medium term double blinded randomised crossover study. They will have optimum RV pacing settings turned on for 3 months. They will then return and be crossed over and have optimum RV pacing turned off for a further 3 months. The primary outcome will be to see if optimum RV pacing being turned on is effective in improving symptoms and quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• All patients will have a clinical diagnosis of HOCM with an LVOT gradient of at least 30 mmHg, at rest or provoked.

• Symptomatic patients

• Can have co-existing mid-cavity obstruction.

• HOCM patients referred for Dual Chamber Pacemaker / ICD Implantation.

• Adults willing to take part (ages 18 - 100 years old)

• Able to give consent.

Locations
Other Locations
United Kingdom
National Heart & Lung Institute, Imperial College London
London
Time Frame
Start Date: 2022-03-14
Completion Date: 2025-05-16
Participants
Target number of participants: 60
Treatments
Active_comparator: Optimum Right Ventricular Pacing On
AV Delay Optimised RV Pacing. Subjects will remain in this arm for 3 months before being crossed-over.
No_intervention: Optimum Right Ventricular Pacing Off
Subjects will remain in this arm for 3 months before being crossed-over. The pacemaker will be programmed to minimum ventricular pacing \& dynamic AV delay will be programmed off.
Sponsors
Collaborators: British Heart Foundation
Leads: Imperial College London

This content was sourced from clinicaltrials.gov

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