NCT02010515

An Arrhythmia Risk Predictor Trial

Clinical-Electrophysiological Risk Marker Trial Goettingen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 282 (actual)
• Sponsor: University Medical Center Goettingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiomyopathy
• Heart Failure

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-12-12
• Last updated: 2013-12-12

Locations

1 site across 1 country: Germany