Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead

NCT03110627 | Unknown DMC

• 1 other identifier: Dx01
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 9

Brief Summary

This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

Conditions

Cardiac Arrhythmias; Atrial Fibrillation and Flutter; Cardiovascular Diseases; Implantable Cardioverter-Defibrillators

Keywords

Single-chamber ICD (implantable cardioverter-defibrillator); Cardiac Arrhythmias; Atrial fibrillation; Atrial flutter; Stroke

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation or atrial flutter lasting at least 6 minutes

  Atrial Fibrillation or atrial flutter lasting at least 6 minutes detected by the ICD, ECG, Holter monitor or telemetry.

  During the entire time of follow up - 3 years

Secondary Outcomes (5)

• Need for any ICD lead repositioning or replacement

  60 days

• Pneumothorax

  60 days

• New pericardial effusion

  60 days

• Cardiac tamponade

  60 days

• Procedure-related death or wound infection

  60 days

Study Arms (2)

VDD ICD

EXPERIMENTAL

VDD ICD - A single-lead ICD system with the ability to sense atrial rhythm from the floating electrode (a VDD-ICD known as the DX) - Experimental group

Device: VDD ICD (experimental group)

VVI ICD

ACTIVE COMPARATOR

VVI ICD - Single chamber ICD system - Control group

Device: Single chamber VVI ICD (control group)

Interventions

VDD ICD (experimental group) DEVICE

Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group). The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

Also known as: Experimental: DX ICD (experimental group)

VDD ICD

Single chamber VVI ICD (control group) DEVICE

Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group). The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

Also known as: Control: Single chamber VVI ICD

VVI ICD

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ischemic or non-ischemic cardiomyopathy,
• LVEF\<50%, scheduled for primary or secondary prevention ICD
• Treating physicians feel that the use of single chamber ICD is appropriate
• No ECG-documented history of AF or flutter
• Age \> 50 years

You may not qualify if:

• Known AF or flutter
• Current use of class I or III anti-arrhythmic medications
• Participants unwilling to attend study follow-up visits, considered unreliable for compliance or with an anticipated life expectancy less than 3 years

Sponsors & Collaborators

• Unity Health Toronto: lead
• Applied Health Research Centre: collaborator
• Biotronik Canada Inc: collaborator

Study Sites (9)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Vancouver Island Health Authority

Vancouver, British Columbia, V8R 1J8, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L4, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Scarborough and Rouge Hospital - Centenary Site

Toronto, Ontario, M1E 4B9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

IUCPQ - Institut universitaire de cardiologie et de pneumologie de Québec

Laval, Quebec, G1V 4G5, Canada

Location

HSCM - L'Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

CHUS - Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Cardiovascular Diseases; Atrial Flutter; Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Eugene Crystal, MD, FRCP(C)

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: DX AF is a prospective, randomized-controlled, open-label trial. Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group).

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: March 31, 2017
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)