Clinical trial NCT03495297: A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing
Official title: A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventricular Arrythmia
Keywords: subcutaneous implantable cardioverter defibrillator
Defibrillation testing
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2018-04-12
Enrollment: 965
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Failed first appropriate shock in a spontaneous episode
timeFrame: 40 months
Secondary outcomes:
measure: DFT related complications
timeFrame: 24 hours or 30 days
measure: PRAETORIAN Score
timeFrame: up to 24 hours
measure: Pain post implant
timeFrame: 1-4 hours post implant
measure: Appropriate ICD therapy
timeFrame: 40 months
measure: Inappropriate ICD therapy
timeFrame: 40 months
measure: Overall DFT conversion success
timeFrame: 40 months
measure: Successful DFT
timeFrame: 40 months
measure: Time to therapy
timeFrame: 40 months
measure: Time to succesful therapy
timeFrame: 40 months
measure: Shock efficacy
timeFrame: 40 months
measure: Conversion efficacy within 5 shocks in spontaneous episodes
timeFrame: 40 months
measure: S-ICD related complications
timeFrame: 40 months
measure: MACE post DFT
timeFrame: 30 days
measure: Cardiac (pre-)syncope
timeFrame: 40 months
measure: Cardiac decompensation
timeFrame: 40 months
measure: Mortality
timeFrame: 40 months
measure: Length of hospitalization
timeFrame: 40 months
measure: Device or lead repositioning
timeFrame: 40 months
measure: ICD related infection
timeFrame: 40 months
measure: Composite complications 30 days after implant
timeFrame: 30 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Adventh Health System
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: CorVita Science Foundation
state: Illinois
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinaï
state: New York
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Hamburg
country: Germany
facility: Asklepios Kliniken
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
city: Amsterdam
country: Netherlands
facility: OLVG
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Groningen
country: Netherlands
facility: UMCG
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock Univerity Hospital NHS Foundation Trust
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Heart and Chest Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust of the Royal London Hospital
city: Manchester
country: United Kingdom
facility: Manchester Heart Center, Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust, the New Cross Hospital
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Reinoud E Knops, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.