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Survival of Patients With Primary Prophylactic ICD Indication

NCT00619593 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2015-01-12

No results posted yet for this study

Summary

The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients.

This trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.

Conditions

Interventions

OTHER

Intensified diagnostic and treatment measures following 1st appropriate ICD therapy

* Assessment of general health status (weight, BP, NYHA) * Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15) * Echocardiography (LVEF, LVEDD, mitral regurgitation) * Non-invasive ischemia evaluation * Coronary angiography (if indicated by ischemia evaluation) * Upgrade to CRT, if indicated * Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry) * 24 hrs ECG Holter (Heart rate variability) * Further treatment (if applicable) * Changes in ICD settings, or medication

OTHER

Standard follow-up

Standard follow-up in patients without appropriate ICD therapy

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Robert Hatala, Prof. MUDr. · Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2014-04-30
Completion
2014-07-31

Countries

  • Austria
  • Czechia
  • Germany
  • Hungary
  • Israel
  • Latvia
  • New Zealand
  • Poland
  • Slovakia
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT00619593 on ClinicalTrials.gov