The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Arrhythmogenic Right Ventricular Cardiomyopathy Clinical Trial

Official title:

The Role of High Density Surface Cardiac Electrographic Mapping in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy :A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291393
• Other study ID #: CD12/10936
• Secondary ID: 12/YH/0346
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: May 18, 2015
• Start date: August 2012
• Est. completion date: October 2012

Study information

• Verified date: May 2015
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: HRA: UK
• Study type: Interventional

Clinical Trial Summary

The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80 lead ECG may increase the specificity and sensitivity in diagnosing this potentially life threatening inherited cardiac condition. This pilot would form the basis of a much larger clinical trial to test the utility of this novel diagnostic tool.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic

Exclusion Criteria:

• Inability to consent

• Pacing dependent patients

• Other concomitant cardiag disease e.g. coronary artery disease

• Atrial fibrillation

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Cardiomyopathy
• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies

Intervention

Device:
• 80 lead ECG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QRS wave dispersion in an ECG	The difference in QRS wave dispersion between the right and left ventricular leads	5 minutes	No