Survival of Patients With Primary Prophylactic ICD Indication

Sudden Cardiac Death Clinical Trial

— SPIRIT-ICD  

Official title:

Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619593
• Other study ID #: TA079
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2008
• Last updated: January 9, 2015
• Start date: February 2008
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Primary Prevention
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular

Intervention

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
• Standard follow-up
Standard follow-up in patients without appropriate ICD therapy

Locations

Country	Name	City	State
Austria	A.ö. Krankenhaus der Stadt Linz	Linz
Austria	Landesklinikum St. Pölten	St. Poelten
Austria	Wilhelminenspital der Stadt Wien	Wien
Czech Republic	Brno Bohunice	Brno
Czech Republic	Fakultni nemocnice u Svety Anny	Brno
Czech Republic	FN Olomouc, Inerni klinika	Olomouc
Czech Republic	Institute of clinical and experimental medicine	Praha
Czech Republic	Online 24 S.R.O.	Praha
Germany	University Hospital RWTH Aachen	Aachen
Germany	Herz- und Gefäss-Klinik GmbH Bad Neustadt	Bad Neustadt
Germany	Klinikum Bielefeld	Bielefeld
Germany	St. Marien Hospital	Bonn
Germany	Universitätsklinikum Bonn	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	Hannover
Germany	Krankenhaus Landshut-Achdorf	Landshut
Germany	Krankenhaus St. Franziskus	Mönchengladbach
Germany	St. Vincenz Krankenhaus	Paderborn
Germany	University Hospital Rostock	Rostock
Germany	Katharinenhospital	Unna
Hungary	Semmelweis University	Budapest
Hungary	The University of Medicine Debrecen	Debrecen
Israel	Chaim Sheba Medical Center	Tel Hashomer
Latvia	Latvian Center of Cardiology	Riga
New Zealand	Health Waikato, Cardiology Department	Hamilton
Poland	MULTI-MED PLUS Spolka z o.o	Lodz
Poland	Instytut Kardiologii	Warzawa
Slovakia	Ssusch	Banska Bystrica
Slovakia	Kardiologická klinika	Bratislava
Slovakia	VUSCH East Slovak Cardiology Institute	Kosice
Spain	H. Univ. La Fe	Valencia
Switzerland	Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany,  Hungary,  Israel,  Latvia,  New Zealand,  Poland,  Slovakia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		12 months	No
Secondary	Sudden cardiac death		12 months	No
Secondary	Non-sudden cardiac death		12 months	No
Secondary	Risk of 1st heart failure hospitalization		12 months	No
Secondary	No. of VT Storms (> 3 VT/24h)		12 months	No
Secondary	No. of delivered ICD therapies		12 months	No