Tachycardia, VentricularEFFORTLESSNCT01085435
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
An observational study of Tachycardia, Ventricular, run by Boston Scientific Corporation at 44 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- S-ICD System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 994 participants
- Where
- 44 sitesin 10 countries
- Study dates
- 2 Feb 2011to Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post CE mark ICD patients eligible for implantation of the S-ICD system
Who may be able to join
- Age >/= 18yrs
- 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)
- Willing and able to provide written informed consent or have informed consent as provided by a legal representative
- 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.
- 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
- 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
- Age 18 or above, and of legal age to give informed consent specific to national laws
Who cannot join
- Participation in any other investigational study that may interfere with interpretation of the Registry results
- Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
- Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
- Extension Phase Sub-study:
- Subjects with device replacement from the S-ICD to a transvenous ICD
- Subjects with unipolar pacemakers or implanted devices that revert to unipolar pacing
- 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
Trial locations and contacts
44 sites in 10 countries.
44 sites in 10 countries
United Kingdom12 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Bristol Royal Infirmary
Bristol, BS2 8HW
Papworth Hospital
Cambridge, Cambridgeshire, CB23 3RE
Russells Hall Hospital
Dudley, DY1 2HQ
Yorkhill Children's Hospital
Glasgow, G3 8SJ
Leeds General Infirmary
Leeds, Yorkshire, LS1 1YY
Yorkshire Heart Centre
Leeds
St. Bartholomew's Hospital
London, W1G 8SE
Kings College Hospital
London
John Radcliffe Hospital
Oxford, OX3 9DU
Northern General Hospital
Sheffield
Southampton General
Southampton
Germany9 sites
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau
Klinikum Bielefeld
Bielefeld
Medizinische Hochschule Hannover
Hanover
University Hospital Schleswig-Holstein
Lübeck
Universitätsmedizin Mannheim
Mannheim
Ludwig-Maximilians-Universität München, Campus Großhadern
Munich, 81377
Universitätsklinikum Münster
Münster
Marienkrankenhaus Papenburg
Papenburg
Netherlands7 sites
Amsterdam Medisch Centrum
Amsterdam, 1105 AZ
Catharina Eindhoven Hospital
Eindhoven, EJ Eindhoven, 5623
Medisch Spectrum Twente
Enschede, 7513 ER
University Medical Center Groningen
Groningen, 9713
Maastricht University Medical Center
Maastricht, AZ Maastricht, 6202
St Antonius Ziekenhuis
Nieuwegein, 3430 EM
Erasmus Medical Center
Rotterdam, 3000 CA
Italy5 sites
Arnas Garibaldi Nesima
Catania
Ospedale Sacro Cuore Don Calabria
Negrar
Azienda Ospedaliero Universitaria Padova
Padova
Azienda Ospedaliero Universitaria Pisana
Pisa
Policlinico Casilino
Rome
Denmark4 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Rigshospitalet
Copenhagen, København, 2100
Odense University Hospital
Odense, 5000
France3 sites
CHU La Timone
Marseille
Nouvelles Cliniques Nantaises
Nantes
Hôpital Cardiologique du Haut-L'évêque
Pessac
About this study
Official title: Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)
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.
Read the 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.
- Conditions
- Tachycardia, Ventricular
- Being tested
- S-ICD System
- Keywords
- ICD, defibrillator
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ICD SystemDevice
Also called S-ICD Pulse Generator, S-ICD Subcutaneous Electrode, S-ICD Electrode Insertion Tool, S-ICD Programmer
The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
| Study group | Role | What they receive |
|---|---|---|
| EFFORTLESS Main Study | Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study. Receives: Device: S-ICD System | |
| Extension Phase Sub Study | The Sub-Study patients were preferably recruited from the active EFFORTLESS S-ICD patient population. Patients, who had already completed the EFFORTLESS S-ICD Registry in the past, were considered secondarily for participation in the Sub-Study. Receives: Device: S-ICD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative S-ICD Complication Free Rate
The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.
Measured: 30 days post implant
360 Day S-ICD Complication Free Rate
The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.
Measured: Minimum 360 days post implant
Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)
The number of subjects who received at least one inappropriate shock for SVT above the discrimination zone and SVT discriminator errors divided by the total implanted subjects.
Measured: From enrollment to 5-year annual visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study start2 Feb 2011
- Primary completion29 Feb 2020
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 994 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pier Lambiase, Prof., Study chair, St. Bartholomew's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085435
- Sponsor's protocol ID
- 90904925; 90904928
- Acronym
- EFFORTLESS
- Status last verified
- Nov 2024
- First submitted
- 10 Mar 2010
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 28797351Burke 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.
PubMed 25908064Lambiase 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.
PubMed 24670710
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)
- ClinicalTrials.gov ID
- NCT01085435
- Acronym / sponsor ID
- EFFORTLESS / 90904925; 90904928
- Conditions
- Tachycardia, Ventricular
- Keywords
- ICD, defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 994 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2011 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFFORTLESS Main Study | – | Device: S-ICD SystemPatients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study. |
| Extension Phase Sub Study | – | Device: S-ICD SystemThe Sub-Study patients were preferably recruited from the active EFFORTLESS S-ICD patient population. Patients, who had already completed the EFFORTLESS S-ICD Registry in the past, were considered secondarily for participation in the Sub-Study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post CE mark ICD patients eligible for implantation of the S-ICD system
Key inclusion criteria (7 listed)
- Age >/= 18yrs
- 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)
- Willing and able to provide written informed consent or have informed consent as provided by a legal representative
- 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.
- 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
Key exclusion criteria (7 listed)
- Participation in any other investigational study that may interfere with interpretation of the Registry results
- Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
- Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
- Subjects with device replacement from the S-ICD to a transvenous ICD
- Subjects with unipolar pacemakers or implanted devices that revert to unipolar pacing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-ICD SystemAlso: S-ICD Pulse Generator, S-ICD Subcutaneous Electrode, S-ICD Electrode Insertion Tool, S-ICD ProgrammerThe S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool. | Device | EFFORTLESS Main Study, Extension Phase Sub Study |
Primary outcome
Perioperative S-ICD Complication Free Rate
Time frame: 30 days post implant
The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.
360 Day S-ICD Complication Free Rate
Time frame: Minimum 360 days post implant
The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.
Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)
Time frame: From enrollment to 5-year annual visit.
The number of subjects who received at least one inappropriate shock for SVT above the discrimination zone and SVT discriminator errors divided by the total implanted subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28797351Boersma 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.
- Derived from this study: PubMed 25908064Burke 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.
- Derived from this study: PubMed 24670710Lambiase 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.
Related trials for Tachycardia, Ventricular
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier Lambiase, Prof. study chair
St. Bartholomew's Hospital, London
44 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia, Ventricular, run by Boston Scientific Corporation at 44 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United Kingdom, Germany, Netherlands, Italy, Denmark and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative S-ICD Complication Free Rate (time frame: 30 days post implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085435, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.