Surgical Septal Myectomy versus Percutaneous Transluminal Alcohol Septal Ablation in Patients with Hypertrophic Obstructive Cardiomyopathy

Phase 3

Completed

Conditions: HOCM
thickened heart muscle
10028593

Registration Number: NL-OMON56423

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Age between 30-80 years
2. HOCM eligible for either SSM or ASA by a heart team (multi-disciplinary
team)
3. LVOT obstruction >=50 mmHg at rest or during physiological provocation by TTE
4. Symptomatic (NYHA class >=2 ) and/or syncope due to HOCM

Exclusion Criteria

1. Unable to give informed consent
2. A life expectancy of less than 1 year
3. Concomitant intrinsic valvular disease requiring surgery in accordance with
current guidelines
4. Concomitant coronary artery disease not amendable to PCI and thus requiring
coronary artery bypass surgery
5. Not able to perform bicycle ergometry exercise test

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study question is whether ASA is non-inferior to SSM in the<br /><br>improvement of exercise capacity.<br /><br>The primary endpoint is the exercise capacity in the form of Metabolic<br /><br>Equivalent (METs) which will be assessed with a bicycle ergometry exercise test<br /><br>(difference in exercise capacity in Metabolic Equivalents) performed before and<br /><br>1 year after invasive treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are all-cause mortality, cardiovascular mortality (defined<br /><br>as death resulting from acute myocardial infarctions, sudden cardiac death,<br /><br>death due to heart failure, death due to stroke, death due to cardiovascular<br /><br>procedures, death due to cardiovascular hemorrhage and death due to other<br /><br>cardiovascular causes) and Transient Ischemic Attack. Also readmittance,<br /><br>occurrence of atrial fibrillation, ventricular arrhythmias (aborted ventricular<br /><br>fibrillation, ventricular tachycardia), complete heart block requiring<br /><br>permanent pacemaker implantation, and major bleeding, re-intervention, blood<br /><br>sample analysis (ex. NT-pro-BNP, Troponine and creatine-kinase (CK)), symptoms<br /><br>and quality of life evaluation using SF-36 questionnaire will be captured.<br /><br>Follow-up will be on 1, 3 and 5 years. </p><br>