Avoid Transvenous Leads in Appropriate Subjects

Ventricular Arrhythmia Clinical Trial

— ATLAS S-ICD  

Official title:

Avoid Transvenous Leads in Appropriate Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881255
• Other study ID #: ATLAS S-ICD
• Status: Completed
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: February 10, 2022

Study information

• Verified date: May 2022
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare standard, single chamber transvenous ICD to sub-cutaneous ICD in occurrence of perioperative and long term device related complications and failed appropriate clinical shocks and arrhythmic death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: February 10, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: patient must satisfy any ONE of the following two criteria:

1. Patient is = 18 - 60 years old AND has a standard indication for ICD; OR

2. Patient is = 18 years old AND has any one of the following present:

• An inherited arrhythmia syndrome (i.e. Long QT, Brugada, ARVC, hypertrophic or dilated cardiomyopathy, early repolarization syndrome, idiopathic ventricular fibrillation, etc.)

• Prior pacemaker or ICD removal for infection

• Need for hemodialysis

• Prior heart valve surgery (repair or replacement)

• Chronic obstructive pulmonary disease (with FEV1 < 1.5 L)

Exclusion Criteria:

• Mechanical tricuspid valve

• Fontan repair

• Presence of an intra-cardiac shunt

• Known lack of upper extremity venous access

• Need for cardiac pacing for bradycardia indication

• PR interval of > 240 msec

• Patients with permanent pacemaker

• Clinical indication for biventricular pacing

• Patients unwilling to provide informed consent or comply with follow-up

• Pregnant at time of enrollment and implant

• Patients who currently have a ventricular assist device (i.e. LVAD)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrhythmia

Intervention

Device:
• Implantable Cardioverter Defibrillator
Patients will be randomized to receive either a subcutaneous or transvenous ICD.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Mazankowski Alberta Heart Institute	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	IUCPQ-Universite Laval	Laval	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	McGill University Health Centre	Montréal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Victoria Cardiac Arrhythmia Trials Inc.	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Boston Scientific Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Mondésert B, Bashir J, Philippon F, Dubuc M, Amit G, Exner D, Joza J, Birnie DH, Lane C, Tsang B, Korley V, Spears D, Ling A, Djuric A, Crystal E, Hruczkowski T, Roux JF, Carroll S, Essebag V, Krahn AD, Healey JS. Rationale and design of the randomized prospective ATLAS study: Avoid Transvenous Leads in Appropriate Subjects. Am Heart J. 2019 Jan;207:1-9. doi: 10.1016/j.ahj.2018.09.008. Epub 2018 Oct 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of lead-related perioperative complications	This composite includes: Hemothorax or pneumothorax; Cardiac perforation, tamponade, pericardial effusion or pericarditis; Lead dislodgement or loss of pacing/sensing requiring revision; New moderate-severe or severe tricuspid insufficiency (3+ or 4+); Ipsilateral upper extremity deep venous thrombosis.	6 months post-ICD implantation
Primary	Additional safety composite	This composite includes: Device-related infection requiring surgical revision; Significant wound hematoma (requiring evacuation or interruption of oral anticoagulation); Myocardial infarction; Stroke; Death;	6 months post-ICD implantation
Secondary	Late device-related complications	The following complications will be measured by their presence or absence; they will be presented as individual complications and also as a composite of late device-related complications: Lead dislodgement or fracture; or loss of adequate sensing or pacing; Device-related infection; Pericarditis or pericardial effusion; New severe tricuspid insufficiency; Ipsilateral upper extremity deep venous thrombosis; Need to revise dialysis access; Need to revise ICD or lead for any reason; Non-systemic embolism; Pulmonary embolism; Wound dehiscence or disjunction; Allergic reaction to ICD	Greater than 6 months post-ICD implantation
Secondary	Total device-related complications	This is a composite of: all components of the primary and secondary safety outcomes, and late device-related complications.	Greater than 6 months post-ICD implantation
Secondary	Occurrence of failed appropriate shock or arrhythmic death	Efficacy outcome	6 months post-ICD implantation
Secondary	Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure	Efficacy outcome. Hospital, emergency department or clinic visits for ICD therapy (shocks or anti-tachycardia pacing, both appropriate and inappropriate), device-related complications, arrhythmia or heart failure	6 months post-ICD implantation
Secondary	Any inappropriate ICD therapy shock	Efficacy outcome	6 months post-ICD implantation
Secondary	All-cause mortality	Efficacy outcome	6 months post-ICD implantation
Secondary	Provincial healthcare payer health economics analysis	A formal health economics analysis will be completed as part of this study, using the perspective of a provincial healthcare payer. Procedural costs will be obtained from the Ontario schedule of benefits and the cost of device-implantation will be taken from existing, local case-costing data. The cost-effectiveness analysis will take into consideration any differences in survival, complication rates and resource utilization. Sensitivity analyses will be done, varying the price of the S-ICD, in order to generate cost-acceptability curves.	6 months post-ICD implantation
Secondary	Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS)	Patient acceptance of ICD will be measured using the Florida Patient Acceptance Survey (FPAS).	1 month and 6 month post-ICD implantation
Secondary	Patient Health Survey as measured by Short Form Health Survey (SF36)	Patient health will be assessed by a generic instrument, the Short Form Health Survey (SF36). This survey provides scores for each of the eight health domains and psychometrically-based physical component summary and mental component summary scores.	Baseline and 6 months post-ICD implantation