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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56423

Enrollment

Unknown

Registered

2021-07-12

Start date

2021-07-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HOCM

Interventions

Patients will be treated with transcatheter ASA or SSM according to hospitals` local standards.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)