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

NCT ID: NCT02291393

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-10-31

Brief 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.

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient

Patients with previously confirmed Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Group Type: OTHER

80 lead ECG

Intervention Type: DEVICE

Healthy volunteers

Aged and gender matched healthy controls.

Group Type: OTHER

80 lead ECG

Intervention Type: DEVICE

Interventions

80 lead ECG

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

12/YH/0346

Identifier Type: OTHER

Identifier Source: secondary_id

CD12/10936

Identifier Type: -

Identifier Source: org_study_id