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An Arrhythmia Risk Predictor Trial

NCT02010515 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 282

Last updated 2013-12-12

No results posted yet for this study

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

Sponsors & Collaborators

  • University Medical Center Goettingen

    lead OTHER

Principal Investigators

  • Markus Zabel, M.D. · University Medical Center Goettingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010515 on ClinicalTrials.gov