A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

NCT ID: NCT03495297

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 965 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2025-07-31

Brief Summary

This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

Detailed Description

Implantable Cardioverter Defibrillator (ICD) implant improves survival in patients with a higher risk for sudden cardiac death. There are 2 types of ICD available; transvenous ICD (TV-ICD) and subcutaneous ICD (S-ICD). During ICD implant, defibrillation testing (DFT) is performed to test functionality of the device. However, DFT can be associated with complications such as inability to convert, complications arising from general anaesthesia, prolonged resuscitation, stroke and death. Whereas DFT may be associated with complications, the benefit of DFT is debated as literature shows there is only a modest average effect of DFT, if any, on mortality, shock efficacy or safety. Recently it was shown in a randomized controlled trial called 'SIMPLE' that routine defibrillation testing of TV-ICDs at the time of implant does not improve shock efficacy or reduce arrhythmic death. For S-ICD there is only limited data available of the effect of DFT on S-ICD efficacy. Data have however shown that the conversion efficacy of the S-ICD is comparable to TV-ICD.

DFT is currently performed in standard S-ICD implants, but is omitted in specific cases. However, an alternative method to evaluate the correct position may be desired when omitting DFT. The PRAETORIAN Score is developed using computer modelling data on factors influencing defibrillation thresholds. The PRAETORIAN score represents the chance of a patient having an elevated defibrillation threshold and consequently failing a DFT or conversion of a spontaneous arrhythmia episode. The score was retrospectively validated in two studies with 180 and 321 patients.

It was reported that most S-ICD implants are performed under general anesthesia, however other anesthesia protocols are used as well. One of the most predominant factors to use general anesthesia is the performance of the DFT. If this is omitted, other anesthesia protocols may be a good option for many patients as well.

Conditions

Ventricular Arrythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

S-ICD Implant with defibrillation test

Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant

Group Type: NO_INTERVENTION

No interventions assigned to this group

S-ICD Implant without defibrillation test

Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant

Group Type: EXPERIMENTAL

ommitence of defibrillation testing

Intervention Type: PROCEDURE

Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted

Interventions

ommitence of defibrillation testing

Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD
• Patients must pass S-ICD screening per local routine
• Patients over 18 years of age, willing and capable to give informed consent
• Patients must be willing and capable of complying to follow up visits
• Patient must be eligible for either DFT strategy per physician discretion

Exclusion Criteria

• Patient with a life expectancy shorter than 12 months due to any medical condition
• Patients known to be pregnant
• Patients with intracardiac thrombus
• Patients with atrial fibrillation without appropriate anticoagulation
• Patients likely to undergo heart transplant within 12 months
• Patients with LVAD
• Patients with other contra-indications for DFT per physician's discretion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

R.E. Knops

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reinoud E Knops, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Adventh Health System

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

CorVita Science Foundation

Chicago, Illinois, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Mount Sinai Beth Israel

New York, New York, United States

Icahn School of Medicine at Mount Sinaï

New York, New York, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Asklepios Kliniken

Hamburg, , Germany

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Universitätsklinikum Mannheim

Mannheim, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Flevoziekenhuis

Almere Stad, , Netherlands

Academic Medical Center Amsterdam

Amsterdam, , Netherlands

OLVG

Amsterdam, , Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

UMCG

Groningen, , Netherlands

Spaarne Gasthuis

Haarlem, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Basildon and Thurrock Univerity Hospital NHS Foundation Trust

Basildon, , United Kingdom

Blackpool Victoria Hospital NHS Foundation Trust

Blackpool, , United Kingdom

Royal Papworth Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

Barts Health NHS Trust of the Royal London Hospital

London, , United Kingdom

Manchester Heart Center, Manchester Royal Infirmary

Manchester, , United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital

Sheffield, , United Kingdom

The Royal Wolverhampton NHS Trust, the New Cross Hospital

Wolverhampton, , United Kingdom

Countries

United States; Germany; Netherlands; United Kingdom

References

Quast ABE, Baalman SWE, Betts TR, Boersma LVA, Bonnemeier H, Boveda S, Brouwer TF, Burke MC, Delnoy PPHM, El-Chami M, Kuschyk J, Lambiase P, Marquie C, Miller MA, Smeding L, Wilde AAM, Knops RE. Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing. Am Heart J. 2019 Aug;214:167-174. doi: 10.1016/j.ahj.2019.05.002. Epub 2019 May 16.

Reference Type: BACKGROUND

PMID: 31220775 (View on PubMed)

Other Identifiers

NL64634_018_18

Identifier Type: -

Identifier Source: org_study_id