Survival of Patients With Primary Prophylactic ICD Indication

NCT ID: NCT00619593

Last Updated: 2015-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2014-07-31

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.

Detailed Description

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.

After standard ICD implantation procedure, the following steps are performed at the pre-discharge follow-up:

• Programming: VR-T: VVI 40 ppm, Onset 20%, Stability 20 ms
• DR-T: DDD 50-60 ppm, activation of IRSplus and SMART
• HF-T: DDD-BiV 50-60 ppm, achieve at least 85% biventricular resynchronisation, activation of SMART
• All devices: VT zone as therapy zone, VF zone. Programming recommendations for VT/VF zones to standardize treatment:

• VF zone: 200-250 bpm/ 300-240 ms, ATPoneshot ON
• VT1 zone: 167-200 bpm/ 360-300 ms, ATP ON
• VT2 zone: 120-167 bpm/ 500-360 ms, ATP ON
• Activation of Home Monitoring (HM) and online registration for HM service

Standard Follow-up: Timing and scope of follow-up in patients without episodes is to the physician's own discretion and should follow the standard clinical routine.

Follow-up after 1st appropriate ICD therapy: Immediately after having received the 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy. Standard ICD follow-up has to be started within 72 hours after 1st appropriate ICD therapy.

• ICD interrogation
• 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
• Adverse events / adverse device effects

Final follow-up visit: For patients without appropriate ICD therapy, the final follow-up shall be performed 12 months after enrolment.

For patients with appropriate ICD therapy, the final follow-up shall be performed 12 months after 1st appropriate ICD therapy.

The final follow-up visit comprises:

• ICD interrogation
• General health status (weight, BP, NYHA)
• Echocardiography (LVEF, LVEDD, mitral regurgitation)
• Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15)
• 24 hrs ECG Holter (Heart rate variability)
• Further treatment (if applicable)
• Changes in ICD settings, or medication
• Adverse events / adverse device effects

Conditions

Primary Prevention; Tachycardia, Ventricular; Sudden Cardiac Death

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2

Standard follow-up in patients without appropriate ICD therapy

Group Type: ACTIVE_COMPARATOR

Standard follow-up

Intervention Type: OTHER

Standard follow-up in patients without appropriate ICD therapy

1

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.

Group Type: EXPERIMENTAL

Intensified diagnostic and treatment measures following 1st appropriate ICD therapy

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Standard follow-up

Standard follow-up in patients without appropriate ICD therapy

Intervention Type: OTHER

Other Intervention Names

Intensified diagnostic and treatment measures

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hatala, Prof. MUDr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

A.ö. Krankenhaus der Stadt Linz

Linz, , Austria

Landesklinikum St. Pölten

Sankt Pölten, , Austria

Wilhelminenspital der Stadt Wien

Vienna, , Austria

Brno Bohunice

Brno, , Czechia

Fakultni nemocnice u Svety Anny

Brno, , Czechia

FN Olomouc, Inerni klinika

Olomouc, , Czechia

Online 24 S.R.O.

Prague, , Czechia

Institute of clinical and experimental medicine

Prague, , Czechia

University Hospital RWTH Aachen

Aachen, , Germany

Herz- und Gefäss-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, , Germany

Klinikum Bielefeld

Bielefeld, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

St. Marien Hospital

Bonn, , Germany

Klinikum Detmold Lippe

Detmold, , Germany

Klinikum Mitte

Dortmund, , Germany

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, , Germany

Evangelisches Krankenhaus

Düsseldorf, , Germany

Hermann-Josef-Krankenhaus

Erkelenz, , Germany

Justus Liebig Universität Gießen

Giessen, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Krankenhaus Landshut-Achdorf

Landshut, , Germany

Krankenhaus St. Franziskus

Mönchengladbach, , Germany

St. Vincenz Krankenhaus

Paderborn, , Germany

University Hospital Rostock

Rostock, , Germany

Katharinenhospital

Unna, , Germany

Semmelweis University

Budapest, , Hungary

The University of Medicine Debrecen

Debrecen, , Hungary

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Latvian Center of Cardiology

Riga, , Latvia

Health Waikato, Cardiology Department

Hamilton, , New Zealand

MULTI-MED PLUS Spolka z o.o

Lodz, , Poland

Instytut Kardiologii

Warzawa, , Poland

Ssusch

Banská Bystrica, , Slovakia

Kardiologická klinika

Bratislava, , Slovakia

VUSCH East Slovak Cardiology Institute

Košice, , Slovakia

H. Univ. La Fe

Valencia, , Spain

Universitätsspital Basel

Basel, , Switzerland

Countries

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

Other Identifiers

TA079

Identifier Type: -

Identifier Source: org_study_id