Survival of Patients With Primary Prophylactic ICD Indication

NCT00619593 | Completed Phase 4

• 1 other identifier: TA079
• Study Type: interventional
• Target: 504
• Locations: 11 countries
• Sites: 37

Brief 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

Primary Prevention; Tachycardia, Ventricular; Sudden Cardiac Death

Keywords

Heart failure; Ventricular Fibrillation; Sudden cardiac death; Hospitalization due to heart failure; Implantable cardioverter-defibrillator; Risk of 1st heart failure hospitalization

Outcome Measures

Primary Outcomes (1)

• Mortality

  12 months

Secondary Outcomes (5)

• Sudden cardiac death

  12 months

• Non-sudden cardiac death

  12 months

• Risk of 1st heart failure hospitalization

  12 months

• No. of VT Storms (> 3 VT/24h)

  12 months

• No. of delivered ICD therapies

  12 months

Study Arms (2)

2

ACTIVE COMPARATOR

Standard follow-up in patients without appropriate ICD therapy

Other: Standard follow-up

1

EXPERIMENTAL

Following 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy.

Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy

Interventions

Intensified diagnostic and treatment measures following 1st appropriate ICD therapy OTHER

* 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

Also known as: Intensified diagnostic and treatment measures

1

Standard follow-up OTHER

Standard follow-up in patients without appropriate ICD therapy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for ICD implantation according to MADIT-II:
• Myocardial infarction 30 days or more before implantation
• LVEF of 30% or less within 3 months before implantation
• Angiography within the preceding 12 months
• The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent

You may not qualify if:

• Patients with contraindication for ICD implantation
• Conventional ICD indication (i.e. other than MADIT-II)
• Myocardial infarction within the past 30 days
• Coronary revascularisation within the preceding 3 months (i.e., if revascularization has been performed wait at least 3 months until enrolment, given that no appropriate/ inappropriate ICD therapy has occured)
• NYHA functional class IV
• Unexplained syncope within 3 years
• Advanced cerebrovascular disease
• Life expectancy very probably below 12 months
• Pregnant or breast-feeding women
• Age \< 18 years
• Patients who are already enrolled in another study (therapy/intervention phase)

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (37)

A.ö. Krankenhaus der Stadt Linz

Linz, 4020, Austria

Location

Landesklinikum St. Pölten

Sankt Pölten, 3100, Austria

Location

Wilhelminenspital der Stadt Wien

Vienna, 1160, Austria

Location

Brno Bohunice

Brno, 62500, Czechia

Location

Fakultni nemocnice u Svety Anny

Brno, 65691, Czechia

Location

FN Olomouc, Inerni klinika

Olomouc, 77520, Czechia

Location

Online 24 S.R.O.

Prague, 12000, Czechia

Location

Institute of clinical and experimental medicine

Prague, 1421, Czechia

Location

University Hospital RWTH Aachen

Aachen, 52074, Germany

Location

Herz- und Gefäss-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Klinikum Bielefeld

Bielefeld, 33604, Germany

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

St. Marien Hospital

Bonn, 53115, Germany

Location

Klinikum Detmold Lippe

Detmold, 32756, Germany

Location

Klinikum Mitte

Dortmund, 44137, Germany

Location

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, 01067, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Hermann-Josef-Krankenhaus

Erkelenz, 41812, Germany

Location

Justus Liebig Universität Gießen

Giessen, 35392, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Krankenhaus Landshut-Achdorf

Landshut, 84034, Germany

Location

Krankenhaus St. Franziskus

Mönchengladbach, 41063, Germany

Location

St. Vincenz Krankenhaus

Paderborn, 33098, Germany

Location

University Hospital Rostock

Rostock, 18055, Germany

Location

Katharinenhospital

Unna, 59423, Germany

Location

Semmelweis University

Budapest, 1122, Hungary

Location

The University of Medicine Debrecen

Debrecen, 4012, Hungary

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Latvian Center of Cardiology

Riga, 1002, Latvia

Location

Health Waikato, Cardiology Department

Hamilton, New Zealand

Location

MULTI-MED PLUS Spolka z o.o

Lodz, 95336, Poland

Location

Instytut Kardiologii

Warzawa, 04-628, Poland

Location

Ssusch

Banská Bystrica, 97401, Slovakia

Location

Kardiologická klinika

Bratislava, 833 48, Slovakia

Location

VUSCH East Slovak Cardiology Institute

Košice, 04001, Slovakia

Location

H. Univ. La Fe

Valencia, 46009, Spain

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Death, Sudden, Cardiac; Heart Failure; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Officials

• Robert Hatala, Prof. MUDr.

  Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01

Locations

IL (1); LA (1); DE (17); NZ (1); HU (2); SL (3); PL (2); AU (3); CZ (5); CH (1); ES (1)