Atrial FibrillationNCT03164395
The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation
A study testing Internal Cardioversion and External Cardioversion in people with Atrial Fibrillation, run by University of Kentucky at 1 site in United States.
Trial summary
This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Internal Cardioversion and External Cardioversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 23 Oct 2018
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- greater than 18 years of age
- persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion
- have an implantable cardiac defibrillator
Who cannot join
- over the age of 99
- pregnant
- prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation
This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.
Read the detailed description
This study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion, but the presence of the SVC defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. Currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. Internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. External cardioversion may carry a small risk of damaged to the CIED.
The investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion.
- Conditions
- Atrial Fibrillation
- Being tested
- Internal Cardioversion, External Cardioversion
- Keywords
- atrial fibrillation, implantable cardiac defibrillator, cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal CardioversionProcedure or surgery
Internal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol
External CardioversionProcedure or surgery
External Cardioversion per institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| Internal Cardioversion | Experimental | Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol. Receives: Procedure: Internal Cardioversion |
| External Cardioversion | Active comparator | Patients randomized to internal cardioversion will have a maximum energy shock delivered from the device between the RV coil and can. If cardioversion is not successful they will then undergo external cardioversion per institutional protocol. Receives: Procedure: External Cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Conversion of Atrial Fibrillation to Sinus Rhythm
Does the patient return for at least one beat to sinus rhythm following the administration of a shock
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jul 2017
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in block fashion to either internal or external cardioversion
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samy C Elayi, MD, University of Kentucky
- Investigators
- Samy C Elayi, MD, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164395
- Sponsor's protocol ID
- 16-0536
- Status last verified
- Mar 2019
- First submitted
- 21 May 2017
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03164395
- Acronym / sponsor ID
- 16-0536
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, implantable cardiac defibrillator, cardioversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 23 May 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 seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.
Detailed description
This study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion, but the presence of the SVC defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. Currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. Internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. External cardioversion may carry a small risk of damaged to the CIED.
The investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in block fashion to either internal or external cardioversion
| Arm | Type | Receives |
|---|---|---|
| Internal Cardioversion | Experimental | Procedure: Internal CardioversionPatients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol. |
| External Cardioversion | Active comparator | Procedure: External CardioversionPatients randomized to internal cardioversion will have a maximum energy shock delivered from the device between the RV coil and can. If cardioversion is not successful they will then undergo external cardioversion per institutional protocol. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- greater than 18 years of age
- persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion
- have an implantable cardiac defibrillator
Key exclusion criteria (3 listed)
- over the age of 99
- pregnant
- prisoner
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 |
|---|---|---|
| Internal CardioversionInternal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol | Procedure or surgery | Internal Cardioversion |
| External CardioversionExternal Cardioversion per institutional protocol | Procedure or surgery | External Cardioversion |
Primary outcome
Acute Conversion of Atrial Fibrillation to Sinus Rhythm
Time frame: Immediate
Does the patient return for at least one beat to sinus rhythm following the administration of a shock
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Samy C Elayi, MD study chair
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Cardioversion and External Cardioversion in people with Atrial Fibrillation, run by University of Kentucky at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute Conversion of Atrial Fibrillation to Sinus Rhythm (time frame: Immediate). 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 22 Mar 2019.