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NCT02806479 Clinical Trial

Hypertrophic Cardiomyopathy Pilot Study

Coronary Artery Disease Clinical Trial

Official title:
Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02806479
Other study ID # 15049
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date September 2020

Study information
Verified date September 2020
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Diagnosed HCM

- Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest

- Maximal left ventricular wall thickness of > 30mm

- Extensive fibrosis on cardiac MRI (>15% of total myocardial volume)

- >7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD

Exclusion Criteria:

- age < 18 years

- Pregnancy

- Atrial Fibrillation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observational: Arrhythmogenic Substrate

Locations
Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Perez-Alday EA, Haq KT, German DM, Hamilton C, Johnson K, Phan F, Rogovoy NM, Yang K, Wirth A, Thomas JA, Dalouk K, Fuss C, Ferencik M, Heitner S, Tereshchenko LG. Mechanisms of Arrhythmogenicity in Hypertrophic Cardiomyopathy: Insight From Non-invasive E — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Non-invasively reconstructed epicardial activation map within one day
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