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OpenTrials
Completed

NCT Number: NCT02010515

An Arrhythmia Risk Predictor Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Goettingen

Göttingen, 37075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no consent
  • atrial fibrillation

Treatment and study plan

Primary outcomes

  1. All-Cause Mortality

    Time frame: 2008-2013

  2. First Appropriate ICD Shock

    Time frame: 2008-2013

    First ICD discharge for malignant ventricular arrhythmia

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Official study title

Clinical-Electrophysiological Risk Marker Trial Goettingen

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2013
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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