Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy (AMARONE)

St. Antonius Hospital

Status: Enrolling

Conditions: Hypertrophic Cardiomyopathy

Treatments: Procedure: Surgical Septal Myectomy; Procedure: Alcohol Septal Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04684290

NL73176.100.20

Details and patient eligibility

About

The aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (ASA) or surgical septal myectomy (SSM).

Full description

This is a prospective, multicentre, open label, randomized controlled, non-inferiority trial (RCT) with a 1:1 randomization to alcohol septal ablation or surgical septal myectomy in patients with hypertrophic obstructive cardiomyopathy (HOCM) between 40-75 year of age with symptoms and/or syncope due to HOCM despite medical therapy. A total of 100 patients will be included. All patients will be evaluated with bicycle ergometry exercise test, MRI and 2D-echo before and 1 year after invasive treatment. Follow-up will be at 1,3 and 5 years.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 40-75 years including 40 and 75 years of age
2. HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab.
3. Left ventricle outflow tract (LVOT) obstruction > 30mmHg at rest or during physiological provocation by transthoracic echocardiogram
4. Symptomatic (New York Heart Association classification (NYHA) >1 or Canadian Cardiovascular Society (CCS) class >1) 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 (structural valve disease, aorta, rhythm, CABG) surgery during the same session
4. Not able to perform bicycle ergometry exercise test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Alcohol Septal Ablation

Active Comparator group

Treatment:

Procedure: Alcohol Septal Ablation

Surgical Septal Myectomy

Active Comparator group

Treatment:

Procedure: Surgical Septal Myectomy