A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy (PRAETORIAN)
This study is currently recruiting participants.
Verified December 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
Top Medical
Information provided by (Responsible Party):
R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01296022
First received: January 12, 2011
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
| Condition | Intervention |
|---|---|
|
Ventricular Arrhythmias |
Device: Implantation of subcutaneous ICD Device: Implantation of transvenous ICD |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing |
Resource links provided by NLM:
Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Primary Outcome Measures:
- Number of participants with implantable cardioverter defibrillator (ICD) related adverse events [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]ICD related adverse events are defined as inappropriate shocks and/or implant-, lead- and device related complications. An inappropriate shock is shock therapy for anything else but ventricular fibrillation or ventricular tachycardia. Implant related complications are defined as ICD related infections, ICD related bleedings, thrombotic events, need for lead reposition, post-implant pneumothorax, post-implant hematothorax, or post-implant perforation/tamponade. Lead- or device related complications are all complications related to the lead or device.
Secondary Outcome Measures:
- Number of Major Adverse Cardiac Event (MACE) [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery
- Number of appropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
- Number of inappropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Inappropriate shocks are defined as above.
- Number of complications individually [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Complications are defined as above.
- Quality of life [ Time Frame: 30 months ] [ Designated as safety issue: No ]The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
- Time to successful therapy [ Time Frame: 30 months ] [ Designated as safety issue: No ]Time to successful therapy is the time between the start of VT or VF until the first successful shock or first successful ATP episode. This includes the time of sensing and charging.
- First shock conversion efficacy [ Time Frame: 30 months ] [ Designated as safety issue: No ]First shock conversion efficacy is the amount of patients with VT or VF who are successfully converted with the first shock given by the transvenous ICD or subcutaneous ICD.
- Implant procedure time [ Time Frame: 30 months ] [ Designated as safety issue: No ]Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).
- Hospitalization rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
- Fluoroscopy time [ Time Frame: 30 months ] [ Designated as safety issue: No ]Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.
- Cardiac (pre-)syncope events [ Time Frame: 30 months ] [ Designated as safety issue: No ]Cardiac syncope is a loss of consciousness due to cerebral hypoperfusion caused by cardiac arrhythmias or presumed cardiac arrhythmias
- Cross-overs to the other arm [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm
| Estimated Enrollment: | 700 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Subcutaneous ICD
Subcutaneous Implantable Cardioverter Defibrillator
|
Device: Implantation of subcutaneous ICD
Implantation of subcutaneous ICD
|
|
Active Comparator: Transvenous ICD
Transvenous Implantable Cardioverter Defibrillator
|
Device: Implantation of transvenous ICD
Implantation of transvenous ICD
|
Detailed Description:
Background of the study: The use of implantable cardioverter defibrillators (ICDs) is an established therapy for the prevention of death from ventricular arrhythmia. Recently a new subcutaneous ICD has been introduced, eliminating the need for transvenous lead placement in or on the heart which is mandatory in the transvenous ICD. The new subcutaneous ICD therapy already proved to be feasible and safe and is an approved therapy in Europe. It is likely that the eliminated need for transvenous lead placement substantially reduces the implantation related complications and elongates lead longevity and thus reduces inappropriate shocks associated with lead fractures. On the other hand it is unclear whether the lack of capability to provide antitachy-pacing (ATP) in the subcutaneous ICD may be a limitation for patients with frequent recurrent ventricular tachycardia. This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous ICD.
Objectives of the study: (1) To compare the subcutaneous ICD to the transvenous ICD for major adverse events (i.e. inappropriate shocks, acute and chronic implant related complications and lead- or device related complications). (2) To determine to which degree the lack of ATP function leads to more appropriate shocks in patients with a subcutaneous ICD.
Study design: Multicenter, prospective, randomized controlled trial with either treatment with the transvenous ICD or subcutaneous ICD (1:1).
Study population: 2x350 patients with class I or IIa indication for ICD therapy without an indication for pacing.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients 18 years and older
- Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
Exclusion Criteria:
- Patients with documented therapy refractory monomorphic ventricular tachycardia
- Patients having an indication for pacing therapy
- Patients with ventricular tachycardia less than 170 bpm
- Patients failing appropriate QRS/T-wave sensing with the S-ICD ECG patient screening tool provided by Cameron Health
- Patients with incessant ventricular tachycardia
- Patients with a serious known concomitant disease with a life expectancy of less than one year
- Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.)
- Patients who are unable to give informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296022
Contacts
| Contact: Reinoud E Knops, MD | +31205663072 | r.e.knops@amc.nl |
| Contact: Louise R Olde Nordkamp, MD | +31205663072 | l.r.oldenordkamp@amc.nl |
Locations
| Netherlands | |
| Academic Medical Center - University of Amsterdam (AMC-UvA) | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Reinoud E Knops, MD +31205663072 r.e.knops@amc.nl | |
| Principal Investigator: Reinoud E Knops, MD | |
| Sub-Investigator: Louise R Olde Nordkamp, MD | |
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Top Medical
Investigators
| Principal Investigator: | Reinoud E Knops, MD | Academic Medical Center - University of Amsterdam (AMC-UvA) |
More Information
No publications provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | R.E. Knops, Drs. R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT01296022 History of Changes |
| Other Study ID Numbers: | NL34725.018.10, NL34725.018.10 |
| Study First Received: | January 12, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
Heart rhythm disturbances Implantable cardiac defibrillator |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013