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An Arrhythmia Risk Predictor Trial

Clinical-Electrophysiological Risk Marker Trial Goettingen

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02010515
Enrollment
282
Registered
2013-12-12
Start date
2008-01-31
Completion date
2013-05-31
Last updated
2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Heart Failure

Keywords

sudden cardiac death, risk stratification, t-wave alternans, Holter electrocardiography, heart rate turbulence

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.

Interventions

None listed

Sponsors

University Medical Center Goettingen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All-Cause Mortality2008-2013
First Appropriate ICD Shock2008-2013First ICD discharge for malignant ventricular arrhythmia

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026