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Clinical Trials/ISRCTN82621856
ISRCTN82621856
Suspended
Phase 2

Distal ventricular pacing and intraventricular gradient reduction for symptomatic relief in drug-refractory hypertrophic cardiomyopathy patients with mid-cavity obstruction

Queen Mary University of London0 sites25 target enrollmentJanuary 11, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hypertrophic cardiomyopathy
Sponsor
Queen Mary University of London
Enrollment
25
Status
Suspended
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2018
End Date
May 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Male or female, \>18 years
  • 2\. Referred for PPM \+/\- ICD implantation for either primary prevention of sudden cardiac death or other indications such as heart block or obstructive physiology
  • 3\. HCM patients with a mid\-cavity gradient of \=30 mmHg demonstrated by echocardiography and morphology confirmed by cardiac MRI. Gradient confirmed by cardiac catheterisation
  • 4\. All patients should be taking maximum tolerated doses of beta blockers or verapamil with or without disopyramide
  • 5\. Symptoms refractory to optimum medical therapy as above, for example breathlessness, chest pain, dizziness, or syncope

Exclusion Criteria

  • 1\. Patients with multi\-level obstruction, i.e. across the mid\-cavity and outflow tract
  • 2\. Patients with moderate or severe valvular stenosis or regurgitation due to primary valvular disease
  • 3\. Patients with untreated symptomatic coronary disease
  • 4\. Patients in atrial fibrillation at the time of implantation
  • 5\. Pregnancy
  • 6\. Renal failure with eGFR \< 20mL/min
  • 7\. Any patient not suitable in the clinicians opinion
  • 8\. Any patient who is for whatever reason is not expected for more than one year
  • 9\. Patients unable to provide informed consent

Outcomes

Primary Outcomes

Not specified

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