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

Not Applicable

Recruiting

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Procedure: Alcohol Septal Ablation; Procedure: Surgical Septal Myectomy

• Registration Number: NCT04684290
• Lead Sponsor: St. Antonius Hospital

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Study Start: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol Septal Ablation	Alcohol Septal Ablation	-
Surgical Septal Myectomy	Surgical Septal Myectomy	-

Primary Outcome Measures

Name	Time	Method
Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test	1 year after the invasive treatment	The primary endpoint is the improvement of 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 Outcome Measures

Name	Time	Method
Number of participants with hospital Readmittance	Follow up will be 1,3 and 5 years
Number of participants with with complete heart block requiring permanent pacemaker implantation	Follow up will be 1,3 and 5 years
Number of participants with re-intervention	Follow up will be 1,3 and 5 years	One more time need for Alcohol septal ablation or surgical septal myectomy
Number of participants with cardiovascular mortality	Follow up will be 1,3 and 5 years
Number of participants with ventricular arrhythmias	Follow up will be 1,3 and 5 years
Number of participants with all-cause mortality	Follow up will be 1,3 and 5 years
Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ)	Follow up will be 1,3 and 5 years	In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion.
Transthoracic echocardiogram	Follow up will be 1,3 and 5 years	Interventricular septal thickness (mm)
Number of participants with transient Ischemic Attack	Follow up will be 1,3 and 5 years
Number of participants with with occurrence of atrial fibrillation	Follow up will be 1,3 and 5 years
Number of participants with major bleeding	First 30 days	Bleeding rate will be analysed using Bleeding Academic Research Consortium (type 3,4 or 5), TIMI major and VARC major criteria.
Blood sample results	Follow up will be 1,3 and 5 years	Creatine-kinase (CK in U/l)
Cardiac Magnetic Resonance Imaging (CMR) parameters	Follow up will be 1,3 and 5 years	Left ventricle end diastolic volume (ml), left ventricle systolic volume (ml)

Trial Locations

Locations (1)

St. Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands