Primary PreventionPhase 4SPIRIT-ICDNCT00619593
Survival of Patients With Primary Prophylactic ICD Indication
A Phase 4 study testing Intensified diagnostic and treatment measures following 1st appropriate ICD therapy and Standard follow-up in people with Primary Prevention and Tachycardia, Ventricular, run by Biotronik SE & Co. KG at 37 sites in 11 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Prevention, Tachycardia, Ventricular, Sudden Cardiac Death
- What is being tested?
- Intensified diagnostic and treatment measures following 1st appropriate ICD therapy and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 37 sitesin 11 countries
- Study dates
- Feb 2008to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
37 sites in 11 countries.
37 sites in 11 countries
Germany17 sites
University Hospital RWTH Aachen
Aachen, 52074
Herz- und Gefäss-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, 97616
Klinikum Bielefeld
Bielefeld, 33604
Universitätsklinikum Bonn
Bonn, 53105
St. Marien Hospital
Bonn, 53115
Klinikum Detmold Lippe
Detmold, 32756
Klinikum Mitte
Dortmund, 44137
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, 01067
Evangelisches Krankenhaus
Düsseldorf, 40217
Hermann-Josef-Krankenhaus
Erkelenz, 41812
Justus Liebig Universität Gießen
Giessen, 35392
Medizinische Hochschule Hannover
Hanover, 30625
Krankenhaus Landshut-Achdorf
Landshut, 84034
Krankenhaus St. Franziskus
Mönchengladbach, 41063
St. Vincenz Krankenhaus
Paderborn, 33098
University Hospital Rostock
Rostock, 18055
Katharinenhospital
Unna, 59423
Czechia5 sites
Brno Bohunice
Brno, 62500
Fakultni nemocnice u Svety Anny
Brno, 65691
FN Olomouc, Inerni klinika
Olomouc, 77520
Online 24 S.R.O.
Prague, 12000
Institute of clinical and experimental medicine
Prague, 1421
Austria3 sites
A.ö. Krankenhaus der Stadt Linz
Linz, 4020
Landesklinikum St. Pölten
Sankt Pölten, 3100
Wilhelminenspital der Stadt Wien
Vienna, 1160
Slovakia3 sites
Ssusch
Banská Bystrica, 97401
Kardiologická klinika
Bratislava, 833 48
VUSCH East Slovak Cardiology Institute
Košice, 04001
Hungary2 sites
Semmelweis University
Budapest, 1122
The University of Medicine Debrecen
Debrecen, 4012
Poland2 sites
MULTI-MED PLUS Spolka z o.o
Lodz, 95336
Instytut Kardiologii
Warzawa, 04-628
About this study
Official title: Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy
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.
Read the 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
- Being tested
- Intensified diagnostic and treatment measures following 1st appropriate ICD therapy, Standard follow-up
- Keywords
- Heart failure, Ventricular Fibrillation, Sudden cardiac death, Hospitalization due to heart failure, Implantable cardioverter-defibrillator, Risk of 1st heart failure hospitalization
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac, Heart Failure, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified diagnostic and treatment measures following 1st appropriate ICD therapyOther
Also called Intensified diagnostic and treatment measures
- 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-upOther
Standard follow-up in patients without appropriate ICD therapy
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Standard follow-up in patients without appropriate ICD therapy Receives: 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. Receives: Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 12 months
Secondary outcomes (5)
Sudden cardiac death
Measured: 12 months
Non-sudden cardiac death
Measured: 12 months
Risk of 1st heart failure hospitalization
Measured: 12 months
No. of VT Storms (> 3 VT/24h)
Measured: 12 months
No. of delivered ICD therapies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Hatala, Prof. MUDr., Principal investigator, Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619593
- Sponsor's protocol ID
- TA079
- Acronym
- SPIRIT-ICD
- Status last verified
- Jan 2015
- First submitted
- 11 Feb 2008
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy
- ClinicalTrials.gov ID
- NCT00619593
- Acronym / sponsor ID
- SPIRIT-ICD / TA079
- Keywords
- Heart failure, Ventricular Fibrillation, Sudden cardiac death, Hospitalization due to heart failure, Implantable cardioverter-defibrillator, Risk of 1st heart failure hospitalization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Other: Standard follow-upStandard follow-up in patients without appropriate ICD therapy |
| 1 | Experimental | Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapyFollowing 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indication for ICD implantation according to MADIT-II:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified diagnostic and treatment measures following 1st appropriate ICD therapyAlso: Intensified diagnostic and treatment measures* 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 | 1 |
| Standard follow-upStandard follow-up in patients without appropriate ICD therapy | Other | 2 |
Primary outcome
Mortality
Time frame: 12 months
5 secondary outcomes
Sudden cardiac death
Time frame: 12 months
Non-sudden cardiac death
Time frame: 12 months
Risk of 1st heart failure hospitalization
Time frame: 12 months
No. of VT Storms (> 3 VT/24h)
Time frame: 12 months
No. of delivered ICD therapies
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hatala, Prof. MUDr. principal investigator
Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia
37 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intensified diagnostic and treatment measures following 1st appropriate ICD therapy and Standard follow-up in people with Primary Prevention and Tachycardia, Ventricular, run by Biotronik SE & Co. KG at 37 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, Czechia, Austria, Slovakia, Hungary and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.