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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT03110627
• Date of registration: 07/04/2017
• Prospective Registration: No
• Primary sponsor: Unity Health Toronto
• Public title: Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead Dx-AF
• Scientific title: Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead: The Dx-AF Study
• Date of first enrolment: March 31, 2017
• Target sample size: 188
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03110627
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Eugene Crystal, MD, FRCP(C)
• Affiliation: Sunnybrook Health Sciences Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 51 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Implantable Cardioverter-Defibrillators

Cardiac Arrhythmias

Atrial Fibrillation and Flutter

Intervention(s)

Device: VDD ICD (experimental group)

Device: Single chamber VVI ICD (control group)

Primary Outcome(s)

Atrial Fibrillation or atrial flutter lasting at least 6 minutes [Time Frame: During the entire time of follow up - 3 years]

Secondary Outcome(s)

Pneumothorax [Time Frame: 60 days]

Procedure-related death or wound infection [Time Frame: 60 days]

Cardiac tamponade [Time Frame: 60 days]

New pericardial effusion [Time Frame: 60 days]

Need for any ICD lead repositioning or replacement [Time Frame: 60 days]

Secondary ID(s)

Dx01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Applied Health Research Centre

Biotronik Canada Inc