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Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

NCT04230551 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-09-16

No results posted yet for this study

Summary

Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients.

The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.

Conditions

  • HOCM, Hypertrophic Obstructive Cardiomyopathy
  • LVOTO - Left Ventricular Outflow Tract Obstruction
  • Remodeling, Ventricular

Interventions

PROCEDURE

PTSMA

Alcohol Septal Ablation

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Jurrien M ten Berg, MD PhD · St. Antonius Hospital

  • Fatih Arslan, MD PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2023-12-31
Completion
2024-01-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04230551 on ClinicalTrials.gov