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

Ventricular Arrythmia Clinical Trial

— PRAETORIAN-DFT  

Official title:

A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03495297
• Other study ID #: NL64634_018_18
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrythmia

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