A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy

Ventricular Arrhythmias Clinical Trial

— PRAETORIAN  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01296022
• Other study ID #: NL34725.018.10
• Secondary ID: NL34725.018.10
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2011
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.

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: 2x425 patients with class I or IIa indication for ICD therapy without an indication for pacing.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 850
• Est. completion date: December 2023
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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/Boston Scientific

• 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 have had a previous ICD implant

• Patient who receive cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy.

• Patients who are unable to give informed consent

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrhythmias

Intervention

Device:
• Implantation of subcutaneous ICD
Implantation of subcutaneous ICD
• Implantation of transvenous ICD
Implantation of transvenous ICD

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague
Denmark	Rigshospitalet	Copenhagen
Germany	Herzzentrum Dresden	Dresden
Germany	Universitätsklinikum Jena	Jena
Germany	Universtätsklinikum Kiel	Kiel
Germany	Herzzentrum Leipzig	Leipzig
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	University Hospital Grosshadern	Munich
Germany	Universitätsklinikum Wurzburg	Wurzburg
Netherlands	Noordwest Hospital	Alkmaar
Netherlands	Flevoziekenhuis	Almere
Netherlands	Academic Medical Center - University of Amsterdam (AMC-UvA)	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	VU Medical Center	Amsterdam
Netherlands	Amphia Hospital	Breda
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Radboudumc	Nijmegen
Netherlands	ErasmusMC	Rotterdam
Netherlands	Isala Klinikum Zwolle	Zwolle
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Heart & Chest Hospital	Liverpool
United Kingdom	Hammersmith Hospital	London
United Kingdom	Saint Bartholomew's Hospital	London
United Kingdom	St. Georges Hospital of London	London
United Kingdom	Oxford University Hospitals NHS Trust	Oxford
United States	Emory University Hospital	Atlanta	Georgia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	The University of Chicago Medicine	Chicago	Illinois
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Mount SinaÏ Hospital	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	The Valley Hospital	Ridgewood	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Czechia,  Denmark,  Germany,  Netherlands,  United Kingdom, 

References & Publications (4)

Knops RE, Olde Nordkamp LRA, Delnoy PHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, Smeding L, van der Stuijt W, de Weger A, de Wilde KC, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman — View Citation

Knops RE, Pepplinkhuizen S, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, van der Stuijt W, Smeding L, de Veld JA, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman — View Citation

Knops RE, van der Stuijt W, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, Smeding L, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Ve — View Citation

Olde Nordkamp LR, Knops RE, Bardy GH, Blaauw Y, Boersma LV, Bos JS, Delnoy PP, van Dessel PF, Driessen AH, de Groot JR, Herrman JP, Jordaens LJ, Kooiman KM, Maass AH, Meine M, Mizusawa Y, Molhoek SG, van Opstal J, Tijssen JG, Wilde AA. Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am Heart J. 2012 May;163(5):753-760.e2. doi: 10.1016/j.ahj.2012.02.012. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with implantable cardioverter defibrillator (ICD) related adverse events	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.	48 months
Secondary	Number of Major Adverse Cardiac Event (MACE)	MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery	48 months
Secondary	Number of appropriate shocks	An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.	48 months
Secondary	Number of inappropriate shocks	Inappropriate shocks are defined as above.	48 months
Secondary	Number of complications individually	Complications are defined as above.	48 months
Secondary	Quality of life	The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.	30 months
Secondary	Time to successful therapy	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.	48 months
Secondary	First shock conversion efficacy	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.	48 months
Secondary	Implant procedure time	Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).	48 months
Secondary	Hospitalization rate	The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.	48 months
Secondary	Fluoroscopy time	Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.	48 months
Secondary	Cardiac (pre-)syncope events	Cardiac syncope is a loss of consciousness due to cerebral hypoperfusion caused by cardiac arrhythmias or presumed cardiac arrhythmias	48 months
Secondary	Cross-overs to the other arm	A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm	48 months
Secondary	Cardiac decompensation	Cardiac decompensation refers to acute failure of the heart to maintain adequate blood circulation for which hospitalization and medical treatment is necessary.	48 months