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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03495297
Other study ID # NL64634_018_18
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 7, 2018
Est. completion date October 2024

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 965
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
ommitence of defibrillation testing
Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted

Locations

Country Name City State
Germany Asklepios Kliniken Hamburg
Germany Universitätsklinikum Schleswig-Holstein Kiel
Germany Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck
Germany Universitätsklinikum Mannheim Mannheim
Germany Universitätsklinikum Würzburg Würzburg
Netherlands Flevoziekenhuis Almere
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
United Kingdom 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 States Emory University Hospital Atlanta Georgia
United States Erlanger Health System Chattanooga Tennessee
United States CorVita Science Foundation Chicago Illinois
United States Englewood Hospital and Medical Center Englewood New Jersey
United States Icahn School of Medicine at Mount Sinaï New York New York
United States Mount Sinai Beth Israel New York New York
United States Adventh Health System Orlando Florida

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

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