Boston Scientific Post Market S-ICD Registry

Tachycardia, Ventricular Clinical Trial

— EFFORTLESS  

Official title:

Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085435
• Other study ID #: 90904925; 90904928
• Status: Completed
• Start date: February 2, 2011
• Est. completion date: January 2024

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 994
• Est. completion date: January 2024
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague	Prague 5
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen	København
Denmark	Odense University Hospital	Odense
France	CHU La Timone	Marseille
France	Nouvelles Cliniques Nantaises	Nantes
France	Hôpital Cardiologique du Haut-L'évêque	Pessac
Germany	Universitäts-Herzzentrum Freiburg-Bad Krozingen	Bad Krozingen
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Germany	Klinikum Bielefeld	Bielefeld
Germany	Medizinische Hochschule Hannover	Hannover
Germany	University Hospital Schleswig-Holstein	Lübeck
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Ludwig-Maximilians-Universität München, Campus Großhadern	Munich
Germany	Universitätsklinikum Münster	Münster
Germany	Marienkrankenhaus Papenburg	Papenburg
Italy	Arnas Garibaldi Nesima	Catania
Italy	Ospedale Sacro Cuore Don Calabria	Negrar
Italy	Azienda Ospedaliero Universitaria Padova	Padova
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Policlinico Casilino	Rome
Netherlands	Amsterdam Medisch Centrum	Amsterdam
Netherlands	Catharina Eindhoven Hospital	Eindhoven	EJ Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht	AZ Maastricht
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus Medical Center	Rotterdam
New Zealand	Auckland City Hospital	Auckland
Portugal	Hospital Santa Cruz	Carnaxide
Spain	Complexo Hospitalario Universitario	A Coruña
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Papworth Hospital	Cambridge	Cambridgeshire
United Kingdom	Russells Hall Hospital	Dudley
United Kingdom	Yorkhill Children's Hospital	Glasgow
United Kingdom	Leeds General Infirmary	Leeds	Yorkshire
United Kingdom	Yorkshire Heart Centre	Leeds
United Kingdom	Kings College Hospital	London
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	Southampton General	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Czechia,  Denmark,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days post implant
Primary	360 Day S-ICD Complication Free Rate	The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.	Minimum 360 days post implant
Primary	Percentage of Inappropriate Shocks for AF/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.	From enrollment to 5-year annual visit.