Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01085435




Registration number
NCT01085435
Ethics application status
Date submitted
10/03/2010
Date registered
11/03/2010
Date last updated
24/05/2024

Titles & IDs
Public title
Boston Scientific Post Market S-ICD Registry
Scientific title
Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)
Secondary ID [1] 0 0
90904925; 90904928
Universal Trial Number (UTN)
Trial acronym
EFFORTLESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tachycardia, Ventricular 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - S-ICD System

EFFORTLESS Main Study - Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.

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.


Treatment: Devices: S-ICD System
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Perioperative S-ICD Complication Free Rate
Timepoint [1] 0 0
30 days post implant
Primary outcome [2] 0 0
360 Day S-ICD Complication Free Rate
Timepoint [2] 0 0
Minimum 360 days post implant
Primary outcome [3] 0 0
Percentage of Inappropriate Shocks for AF/SVT
Timepoint [3] 0 0
From enrollment to 5-year annual visit.

Eligibility
Key inclusion 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 (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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2024
Sample size
Target
Accrual to date
Final
994
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Prague 5
Country [2] 0 0
Denmark
State/province [2] 0 0
København
Country [3] 0 0
Denmark
State/province [3] 0 0
Aalborg
Country [4] 0 0
Denmark
State/province [4] 0 0
Aarhus
Country [5] 0 0
Denmark
State/province [5] 0 0
Odense
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Nantes
Country [8] 0 0
France
State/province [8] 0 0
Pessac
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Krozingen
Country [10] 0 0
Germany
State/province [10] 0 0
Bernau
Country [11] 0 0
Germany
State/province [11] 0 0
Bielefeld
Country [12] 0 0
Germany
State/province [12] 0 0
Hannover
Country [13] 0 0
Germany
State/province [13] 0 0
Lübeck
Country [14] 0 0
Germany
State/province [14] 0 0
Mannheim
Country [15] 0 0
Germany
State/province [15] 0 0
Munich
Country [16] 0 0
Germany
State/province [16] 0 0
Münster
Country [17] 0 0
Germany
State/province [17] 0 0
Papenburg
Country [18] 0 0
Italy
State/province [18] 0 0
Catania
Country [19] 0 0
Italy
State/province [19] 0 0
Negrar
Country [20] 0 0
Italy
State/province [20] 0 0
Padova
Country [21] 0 0
Italy
State/province [21] 0 0
Pisa
Country [22] 0 0
Italy
State/province [22] 0 0
Rome
Country [23] 0 0
Netherlands
State/province [23] 0 0
AZ Maastricht
Country [24] 0 0
Netherlands
State/province [24] 0 0
EJ Eindhoven
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Netherlands
State/province [26] 0 0
Enschede
Country [27] 0 0
Netherlands
State/province [27] 0 0
Groningen
Country [28] 0 0
Netherlands
State/province [28] 0 0
Nieuwegein
Country [29] 0 0
Netherlands
State/province [29] 0 0
Rotterdam
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
Portugal
State/province [31] 0 0
Carnaxide
Country [32] 0 0
Spain
State/province [32] 0 0
A Coruña
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Cambridgeshire
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Yorkshire
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Brighton
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Bristol
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Dudley
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Glasgow
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Leeds
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Oxford
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Sheffield
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01085435
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pier Lambiase, Prof.
Address 0 0
St. Bartholomew's Hospital, London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01085435