The Dx-AF study: a prospective, multicenter, randomized controlled trial comparing VDD-ICD to VVI-ICD in detecting sub-clinical atrial fibrillation in defibrillator patients
- 27.07.2017
Erschienen in:
- Verfasst von
- Mohammed Shurrab
- Amir Janmohamed
- Jean-François Sarrazin
- Felix Ayala-Paredes
- Marcio Sturmer
- Randall Williams
- Satish Toal
- Chris Lane
- Kevin E. Thorpe
- Jeff S. Healey
- Eugene Crystal
- Erschienen in
- Journal of Interventional Cardiac Electrophysiology | Ausgabe 1/2017
Abstract
Purpose
Atrial fibrillation (AF) is the most common cardiac dysrhythmia. Appropriate detection of AF and early initiation of oral anticoagulation therapy are critical to reduce the risk of stroke. Patients with implantable cardioverter defibrillators (ICD) are at high risk of developing AF. The purpose of the Dx-AF study is to demonstrate that a novel single-lead VDD-ICD system (Linox smart S DX) will facilitate adequate recognition of sub-clinical AF and ultimately stroke prevention with a comparable safety profile in comparison to VVI-ICD.
Methods and results
Dx-AF is a prospective, randomized controlled, open-label trial. Patients who are indicated to receive a single-chamber ICD will be randomized to a VDD-ICD (experimental group) or single-chamber ICD (control group). We have used a sample size of 355, which after generous allowance for loss-to-follow-up, yields a sample size of 378 patients at up to 13 Canadian sites. The trial will enroll patients with ischemic or non-ischemic cardiomyopathy, age > 50 years, LVEF < 50%, scheduled for primary or secondary prevention single-chamber ICD, with no ECG-documented history of AF or flutter. The primary (efficacy) outcome of this study will be the time to the first detected and confirmed episode of AF or atrial flutter lasting at least 6 min. The secondary (safety) outcome will be a composite outcome of serious device-related complications.
The proposed follow-up period in this trial will be 36 months after randomization.
Conclusions
The Dx-AF Study should provide significant scientific evidence and guidance to an adequate ICD system choice and early AF detection/management hence improve clinical outcomes in a large patient population.
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- Titel
- The Dx-AF study: a prospective, multicenter, randomized controlled trial comparing VDD-ICD to VVI-ICD in detecting sub-clinical atrial fibrillation in defibrillator patients
- Verfasst von
-
Mohammed Shurrab
Amir Janmohamed
Jean-François Sarrazin
Felix Ayala-Paredes
Marcio Sturmer
Randall Williams
Satish Toal
Chris Lane
Kevin E. Thorpe
Jeff S. Healey
Eugene Crystal
- Publikationsdatum
- 27.07.2017
- Verlag
- Springer US
- Erschienen in
-
Journal of Interventional Cardiac Electrophysiology / Ausgabe 1/2017
Print ISSN: 1383-875X
Elektronische ISSN: 1572-8595 - DOI
- https://doi.org/10.1007/s10840-017-0276-0
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