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

Not Applicable

Active, not recruiting

• Conditions: Ventricular Arrythmia

• Registration Number: NCT03495297
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-12
• Study Start: 2018-05-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 965

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Failed first appropriate shock in a spontaneous episode	40 months	Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode

Secondary Outcome Measures

Name	Time	Method
PRAETORIAN Score	up to 24 hours	Implant position will be scored using the PRAETORIAN score
Overall DFT conversion success	40 months	The percentage of patients with at least one induced episode teminated by an S-ICD shock within five seconds post shock delivery
Length of hospitalization	40 months	Length of hospitalization post implant (nights)
Appropriate ICD therapy	40 months	Shocks given for VT or VF
Successful DFT	40 months	A successful DFT is defined as conversion to SR or AF in less than 5 seconds from appropriate shock delivery.
Shock efficacy	40 months	Percentage of appropriate shocks that was successfull
Conversion efficacy within 5 shocks in spontaneous episodes	40 months	Conversion efficacy within 5 shocks in spontaneous episodes
S-ICD related complications	40 months	S-ICD related complications requiring invasive intervention
Mortality	40 months	All cause mortality; arrhythmic death; cardiovascular death; unexplained death
DFT related complications	24 hours or 30 days	Number of patients experiencing DFT related complications occurring within 24h or 30 days after DFT
Pain post implant	1-4 hours post implant	Pain score measured with McGill questionnaire
Time to therapy	40 months	Time to therapy is the time between the start of VT or VF in a treated episode until the first shock in seconds.
Time to succesful therapy	40 months	Time to successful therapy is the time between the start of VT or VF until the first successful shock.
MACE post DFT	30 days	Number of Major Adverse Cardiac Events after DFT procedure
Cardiac (pre-)syncope	40 months	Number of episodes of cardiac (pre-)syncope
Device or lead repositioning	40 months	Number of procedures for device or lead repositioning
ICD related infection	40 months	Number of infections related to implanted ICD
Composite complications 30 days after implant	30 days	Number of patients experiencing complications occurring within 30 days after implant
Inappropriate ICD therapy	40 months	Shocks given for anything else than VT or VF
Cardiac decompensation	40 months	Number of episodes of cardiac decompensation

Trial Locations

Locations (32)

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

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