Cardiac ArrhythmiasDx-AFNCT03110627
Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead
A study testing VDD ICD (experimental group) in people with Cardiac Arrhythmias and Atrial Fibrillation and Flutter, run by Unity Health Toronto at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Cardiac Arrhythmias, Atrial Fibrillation and Flutter, Cardiovascular Diseases
- What is being tested?
- VDD ICD (experimental group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 9 sitesCanada
- Study dates
- 31 Mar 2017to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1
IUCPQ - Institut universitaire de cardiologie et de pneumologie de Québec
Laval, Quebec, G1V 4G5
HSCM - L'Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L4
CHUS - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Scarborough and Rouge Hospital - Centenary Site
Toronto, Ontario, M1E 4B9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Vancouver Island Health Authority
Vancouver, British Columbia, V8R 1J8
About this study
Official title: Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead: The Dx-AF Study
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.
Read the detailed description
Recipients of implantable defibrillators (ICD) are at high risk of developing both AF and stroke, given the presence of multiple cardiovascular risk factors. Oral anticoagulation can prevent most strokes in patients with AF; provided that AF is recognized before a stroke occurs. Up to about 40% of incident AF may be sub-clinical, producing minimal or no symptoms, or being too short to allow detection.
DX AF is a prospective, randomized-controlled, open-label trial. Patients who are identified on clinical grounds for a single-chamber ICD will be 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.
- Conditions
- Cardiac Arrhythmias, Atrial Fibrillation and Flutter, Cardiovascular Diseases, Implantable Cardioverter-Defibrillators
- Being tested
- VDD ICD (experimental group), Single chamber VVI ICD (control group)
- Keywords
- Single-chamber ICD (implantable cardioverter-defibrillator), Cardiac Arrhythmias, Atrial fibrillation, Atrial flutter, Stroke
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Atrial Flutter, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDD ICD (experimental group)Device
Also called Experimental: DX ICD (experimental group)
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.
Single chamber VVI ICD (control group)Device
Also called Control: Single chamber VVI ICD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: VDD ICD (experimental group) |
| VVI ICD | Active comparator | VVI ICD - Single chamber ICD system - Control group Receives: Device: Single chamber VVI ICD (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the entire time of follow up - 3 years
Secondary outcomes (5)
Need for any ICD lead repositioning or replacement
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Measured: 60 days
Pneumothorax
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Measured: 60 days
New pericardial effusion
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Measured: 60 days
Cardiac tamponade
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Measured: 60 days
Procedure-related death or wound infection
Composite outcome of serious device-related complications occurring in the 60 days from the time of ICD insertion.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start31 Mar 2017
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Health Research Centre, Biotronik Canada Inc
- Responsible party
- Sponsor
- Investigators
- Eugene Crystal, MD, FRCP(C), Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110627
- Sponsor's protocol ID
- Dx01
- Acronym
- Dx-AF
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead: The Dx-AF Study
- ClinicalTrials.gov ID
- NCT03110627
- Acronym / sponsor ID
- Dx-AF / Dx01
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Applied Health Research Centre, Biotronik Canada Inc
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recipients of implantable defibrillators (ICD) are at high risk of developing both AF and stroke, given the presence of multiple cardiovascular risk factors. Oral anticoagulation can prevent most strokes in patients with AF; provided that AF is recognized before a stroke occurs. Up to about 40% of incident AF may be sub-clinical, producing minimal or no symptoms, or being too short to allow detection.
DX AF is a prospective, randomized-controlled, open-label trial. Patients who are identified on clinical grounds for a single-chamber ICD will be 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| VDD ICD | Experimental | Device: VDD ICD (experimental group)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 |
| VVI ICD | Active comparator | Device: Single chamber VVI ICD (control group)VVI ICD - Single chamber ICD system - Control group |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VDD ICD (experimental group)Also: Experimental: DX ICD (experimental group)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. | Device | VDD ICD |
| Single chamber VVI ICD (control group)Also: Control: Single chamber VVI ICDPatients 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. | Device | VVI ICD |
Primary outcome
Atrial Fibrillation or atrial flutter lasting at least 6 minutes
Time frame: During the entire time of follow up - 3 years
Atrial Fibrillation or atrial flutter lasting at least 6 minutes detected by the ICD, ECG, Holter monitor or telemetry.
5 secondary outcomes
Need for any ICD lead repositioning or replacement
Time frame: 60 days
Pneumothorax
Time frame: 60 days
New pericardial effusion
Time frame: 60 days
Cardiac tamponade
Time frame: 60 days
Procedure-related death or wound infection
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmias
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Crystal, MD, FRCP(C) principal investigator
Sunnybrook Health Sciences Centre
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VDD ICD (experimental group) in people with Cardiac Arrhythmias and Atrial Fibrillation and Flutter, run by Unity Health Toronto at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation or atrial flutter lasting at least 6 minutes (time frame: During the entire time of follow up - 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.