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

Conditions

Ventricular Arrhythmias

Keywords

Heart rhythm disturbances, Implantable cardiac defibrillator

Brief summary

This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the 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: 2x425 patients with class I or IIa indication for ICD therapy without an indication for pacing.

Louise R.A. Olde Nordkamp, Jolien A. de Veld, Abdul Ghani, Jürgen Kuschyk, Hendrik Bonnemeier et al. (51 authors)

Circulation2025-04-2513 citations

10.1161/circulationaha.125.074576

Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial

Louise R.A. Olde Nordkamp, Shari Pepplinkhuizen, Abdul Ghani, Lucas V.A. Boersma, Jürgen Kuschyk et al. (48 authors)

Circulation Arrhythmia and Electrophysiology2024-12-016 citations

10.1161/circep.124.012836

Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial

Reinoud E. Knops, Jolien A. de Veld, Abdul Ghani, Lucas V.A. Boersma, Jürgen Kuschyk et al. (48 authors)

Circulation Cardiovascular Quality and Outcomes2024-11-016 citations

10.1161/circoutcomes.124.010822

Abstract 13862: Appropriate Therapy in the Subcutaneous and Transvenous ICD: A Secondary Analysis of the PRAETORIAN Trial

Reinoud E. Knops, Willeke van der Stuijt, Peter Paul H.M. Delnoy, Lucas V.A. Boersma, Juergen Kuschyk et al. (48 authors)

Circulation2021-11-16

10.1161/circ.144.suppl_1.13862

Abstract 13768: Gender Differences in ICD-Related Complications in the PRAETORIAN Trial

Reinoud E. Knops, Louise R.A. Olde Nordkamp, Peter Paul H.M. Delnoy, Lucas V.A. Boersma, Juergen Kuschyk et al. (16 authors)

Circulation2021-11-16

10.1161/circ.144.suppl_1.13768

Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial

Reinoud E. Knops, Willeke van der Stuijt, Peter Paul H.M. Delnoy, Lucas V.A. Boersma, Juergen Kuschyk et al. (98 authors)

Circulation2021-11-1451 citations

10.1161/circulationaha.121.057816

Subcutaneous or Transvenous Defibrillator Therapy

Reinoud E. Knops, Louise R.A. Olde Nordkamp, Peter-Paul Delnoy, Lucas V.A. Boersma, Jürgen Kuschyk et al. (32 authors)

New England Journal of Medicine2020-08-05441 citations

10.1056/nejmoa1915932

Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy.

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.

2012-05-01110 citations

10.1016/j.ahj.2012.02.012

Interventions

DEVICEImplantation of subcutaneous ICD

Implantation of subcutaneous ICD

DEVICEImplantation of transvenous ICD

Implantation of transvenous ICD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events	48 months	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

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

Countries

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

Outcome results

None listed