An Arrhythmia Risk Predictor Trial

Sponsor

University Medical Center Goettingen (Other)

Overall Status

Completed

CT.gov ID

NCT02010515

Collaborator

(none)

282

Enrollment

Location

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective single-center study is an observational risk stratification trial in about 250 patients with standard indications for ICD treatment.

Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current guidelines recommend their use for primary and secondary prevention of sudden cardiac death (SCD). However, a large number of patients never receive an appropriate therapy from their device. In contrast, electrical sorm and multiple ICD shocks occur in other patients.

Thus, identification of predictors for survival or ICD shocks is necessary for improved patient selection and optimized therapeutic strategies.

Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave alternans (TWA) and Holter ECG including premature ventricular contractions (PVC), non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and deceleration capacity, as well as clinical variables is possible, but not implemented in clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD for primary or secondary prevention of SCD following current guidelines.

Patients will be prospectively followed and the predictive value of the risk markers mentioned above to predict all-cause mortality or appropriate ICD shocks will be investigated.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathy Heart Failure

Study Design

Study Type:

Observational

Actual Enrollment :

282 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Clinical-Electrophysiological Risk Marker Trial Goettingen

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Sinus rhythm, first ICD implantation

Outcome Measures

Primary Outcome Measures

All-Cause Mortality [2008-2013]
First Appropriate ICD Shock [2008-2013]
First ICD discharge for malignant ventricular arrhythmia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ischemic or dilated cardiomyopathy
sinusrhythm
ICD indication strictly following current guidelines (primary and secondary prevention of SCD)
Age 18 years or older