Clinical trial NCT01085435: Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
Official title: Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachycardia, Ventricular
Keywords: ICD
defibrillator
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post CE mark ICD patients eligible for implantation of the S-ICD system

Brief summary: The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.

Detailed description: EFFORTLESS is an observational, post market, standard of care, Registry to be conducted at approximately 50 centers worldwide in patients requiring an ICD for the treatment of ventricular tachyarrhythmias. Patients included in the registry will have been implanted with the S-ICD system since its CE mark (commercial regulatory approval) and will be followed for up to 60 months. The patients' perception of their therapy will be evaluated using Quality of Life assessments and the Registry will include an exploratory analysis of resource utilization and costs based on measures of clinical outcome such as complication rates, unscheduled hospitalizations and length of stay. The objective will be to enable comparison of costs of the S-ICD system versus a standard transvenous system.

An Extension Phase Sub-Study will extend the EFFORTLESS S-ICD Registry in order to achieve an average of approximately 8 years of follow-up from index procedure. A subgroup of approximately 200 patients will be enrolled at a sub-set of EFFORTLESS sites. The data analysis will focus on long-term S-ICD system-related adverse events, S-ICD replacements and device longevity.

Eligibility criteria: Main study:

Inclusion Criteria

1. Age \>/= 18yrs
2. Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD system (Software (SW) version 1.59.0 or later)
3. Willing and able to provide written informed consent or have informed consent as provided by a legal representative

Exclusion Criteria:

1. Participation in any other investigational study that may interfere with interpretation of the Registry results
2. Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
3. Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing

Extension Phase Sub-study:

Inclusion Criteria

1. Subjects who are actively enrolled in the EFFORTLESS S-ICD Registry OR Subjects who completed the 5-year follow-up in the EFFORTLESS S-ICD Registry. All clinical events, spontaneous and induced episode data and system replacement or revision data since the last EFFORTLESS S-ICD Annual Follow-Up of the main study must be available in medical files or equivalent.
2. Subjects who are actively implanted with an S-ICD pulse generator (SQ-RX, EMBLEM or EMBLEM MRI) and an S-ICD electrode (Q-TRAK or EMBLEM) or any other future commercial available versions
3. Willing and able to provide written informed consent or have informed consent as provided by a legal representative and willing to participate in all testing and follow-ups as described the Sub-Study protocol
4. Age 18 or above, and of legal age to give informed consent specific to national laws

Exclusion Criteria

1. Subjects with device replacement from the S-ICD to a transvenous ICD
2. Subjects with unipolar pacemakers or implanted devices that revert to unipolar pacing
3. Subjects that are participating in any other investigational study that may interfere with interpretation of the Registry results, without the written approval of Boston Scientific

Primary outcomes:
measure: Perioperative S-ICD Complication Free Rate
timeFrame: 30 days post implant
measure: 360 Day S-ICD Complication Free Rate
timeFrame: Minimum 360 days post implant
measure: Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)
timeFrame: From enrollment to 5-year annual visit.
Secondary outcomes:
Other outcomes:
measure: Extension Phase Rate of Long-term S-ICD System-related Adverse Events
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase S-ICD Replacements for Functionality
timeFrame: From enrollment into the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Device Longevity
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Rate of Complications Related to the S-ICD Replacements
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Appropriate Shock Therapy for VT/VF
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Inappropriate Shock Therapy
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase VF Induction Testing at Replacement
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Additional Invasive Interventions
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Additional Invasive Interventions
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Use of Anti-arrhythmic Drugs
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Ventricular Rate of Episodes (Mean)
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Ventricular Rate of Episodes (Median)
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Ventricular Rate of Episodes (IQR)
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Ventricular Rate of Non-Sustained Episodes (Mean)
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Ventricular Rate of Non-Sustained Episodes (Median)
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Extension Phase Ventricular Rate of Non-Sustained Episodes (IQR)
timeFrame: From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.
measure: Complication Events
timeFrame: From enrollment in the initial main study until the 5th annual follow-up of the substudy.
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
state: Prague 5
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: København
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Marseille
country: France
facility: CHU La Timone
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut-L'évêque
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität München, Campus Großhadern
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Papenburg
country: Germany
facility: Marienkrankenhaus Papenburg
city: Catania
country: Italy
facility: Arnas Garibaldi Nesima
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Padova
country: Italy
facility: Azienda Ospedaliero Universitaria Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Rome
country: Italy
facility: Policlinico Casilino
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: AZ Maastricht
city: Eindhoven
country: Netherlands
facility: Catharina Eindhoven Hospital
state: EJ Eindhoven
city: Amsterdam
country: Netherlands
facility: Amsterdam Medisch Centrum
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Carnaxide
country: Portugal
facility: Hospital Santa Cruz
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
state: Cambridgeshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: Yorkshire
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
city: Glasgow
country: United Kingdom
facility: Yorkhill Children's Hospital
city: Leeds
country: United Kingdom
facility: Yorkshire Heart Centre
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Southampton
country: United Kingdom
facility: Southampton General
Study officials:
affiliation: St. Bartholomew's Hospital, London
name: Pier Lambiase, Prof.
role: STUDY_CHAIR
References:
citation: Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.
citation: Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.
citation: Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kaab S, Murgatroyd F, Reeve HL, Carter N, Boersma L; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.