Survival of Patients With Primary Prophylactic ICD Indication (SPIRIT-ICD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00619593
First received: February 11, 2008
Last updated: August 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Primary Prevention
Tachycardia, Ventricular
Sudden Cardiac Death
Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy
Other: Standard follow-up
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sudden cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Non-sudden cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Risk of 1st heart failure hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • No. of VT Storms (> 3 VT/24h) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • No. of delivered ICD therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 504
Study Start Date: February 2008
Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Standard follow-up in patients without appropriate ICD therapy
Other: Standard follow-up
Standard follow-up in patients without appropriate ICD therapy
Other Name: Standard follow-up
Experimental: 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.
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 Name: Intensified diagnostic and treatment measures

  Hide Detailed Description

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619593

  Show 37 Study Locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Robert Hatala, Prof. MUDr. Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00619593     History of Changes
Other Study ID Numbers: TA079
Study First Received: February 11, 2008
Last Updated: August 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Heart failure
Ventricular Fibrillation
Sudden cardiac death
Hospitalization due to heart failure
Implantable cardioverter-defibrillator
Risk of 1st heart failure hospitalization

Additional relevant MeSH terms:
Death
Tachycardia
Tachycardia, Ventricular
Death, Sudden, Cardiac
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on August 28, 2014