Status:
RECRUITING
Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
Lead Sponsor:
St. Antonius Hospital
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
40-75 years
Phase:
NA
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...
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 hype...
Eligibility Criteria
Inclusion
- Age between 40-75 years including 40 and 75 years of age
- HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab.
- Left ventricle outflow tract (LVOT) obstruction \> 30mmHg at rest or during physiological provocation by transthoracic echocardiogram
- Symptomatic (New York Heart Association classification (NYHA) \>1 or Canadian Cardiovascular Society (CCS) class \>1) and/or syncope due to HOCM
Exclusion
- Unable to give informed consent
- A life expectancy of less than 1 year
- Concomitant (structural valve disease, aorta, rhythm, CABG) surgery during the same session
- Not able to perform bicycle ergometry exercise test
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04684290
Start Date
June 30 2021
End Date
May 1 2026
Last Update
September 16 2021
Active Locations (1)
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1
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435cm