Atrial FibrillationNCT02429648
Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation
A study testing DCC first then PVI and PVI then DCC after in people with Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein isolation (PVI)ablation in atrial fibrillation then Direct… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DCC first then PVI and PVI then DCC after
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent or long standing persistent AF resistant to anti-arrhythmic medication. Must have been present for more than 2 months
- Therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or TEE performed prior to the procedure
- Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control
- Scheduled for Pulmonary Vein Isolation
- Amiodarone will be stopped at least 3 months prior to procedure
Who cannot join
- Reversible causes of AF such as pericarditis, hyperthyroidism
- Presently with Valvular Heart disease requiring surgical intervention
- Presently with coronary artery disease requiring surgical intervention
- Early Post-operative AF (within three months of surgery)
- Previous MAZE or left atrial instrumentation
- Life expectancy <= 2 years
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- Social factors that would preclude follow up or make compliance difficult.
- Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
- Enrollment in another investigational drug or device study
- Patients with severe pulmonary disease
- Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of DCC in Patients Undergoing Pulmonary Vein Isolation Ablation (PVI) of Persistent/Permanent Atrial Fibrillation
The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the patient remains in atrial fibrillation.
Read the detailed description
Ablation of persistent/permanent Atrial Fibrillation (AF) remains a challenge. There are several strategies to improve the outcomes of persistent/permanent AF ablation. At the Cleveland Clinic one of the commonly used strategies is Direct Current Cardioversion (DCC). Depending on physician preference, patients may be ablated in atrial fibrillation then Direct current cardioverted; or Direct current cardioverted and ablated in sinus rhythm. Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice.
The purpose of this study is to compare which standard of care strategy is superior in patients with persistent/permanent Atrial Fibrillation undergoing ablation, direct current cardioversion prior to empirical pulmonary vein isolation; or ablation in atrial fibrillation then direct current cardioversion if the patient remains in atrial fibrillation
- Conditions
- Atrial Fibrillation
- Being tested
- DCC first then PVI, PVI then DCC after
- Keywords
- AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCC first then PVIProcedure or surgery
DCC performed prior to PVI
PVI then DCC afterProcedure or surgery
DCC performed after PVI, if patient remains in Atrial Fibrillation
| Study group | Role | What they receive |
|---|---|---|
| PVI performed in Normal Sinus Rhythm | Active comparator | DCC first then PVI Receives: Procedure: DCC first then PVI |
| PVI performed in Atrial Fibrillation | Active comparator | PVI then DCC after if patient remains in Atrial Fibrillation Receives: Procedure: PVI then DCC after |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of procedure
Measured: day of procedure
Secondary outcomes (3)
Composite of duration of fluoroscopy, and radiation exposure doses
Measured: day of procedure
Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG
Measured: 12 months
frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2009
- Primary completionJul 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Saliba, The Cleveland Clinic
- Investigators
- Walid Saliba, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429648
- Sponsor's protocol ID
- 09-308
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2010
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bassiouny M, Saliba W, Hussein A, Rickard J, Diab M, Aman W, Dresing T, Callahan T 4th, Bhargava M, Martin DO, Shao M, Baranowski B, Tarakji K, Tchou PJ, Hakim A, Kanj M, Lindsay B, Wazni O. Randomized Study of Persistent Atrial Fibrillation Ablation: Ablate in Sinus Rhythm Versus Ablate Complex-Fractionated Atrial Electrograms in Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e003596. doi: 10.1161/CIRCEP.115.003596.
PubMed 26857909
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of DCC in Patients Undergoing Pulmonary Vein Isolation Ablation (PVI) of Persistent/Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02429648
- Acronym / sponsor ID
- 09-308
- Conditions
- Atrial Fibrillation
- Keywords
- AF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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.
The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the patient remains in atrial fibrillation.
Detailed description
Ablation of persistent/permanent Atrial Fibrillation (AF) remains a challenge. There are several strategies to improve the outcomes of persistent/permanent AF ablation. At the Cleveland Clinic one of the commonly used strategies is Direct Current Cardioversion (DCC). Depending on physician preference, patients may be ablated in atrial fibrillation then Direct current cardioverted; or Direct current cardioverted and ablated in sinus rhythm. Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice.
The purpose of this study is to compare which standard of care strategy is superior in patients with persistent/permanent Atrial Fibrillation undergoing ablation, direct current cardioversion prior to empirical pulmonary vein isolation; or ablation in atrial fibrillation then direct current cardioversion if the patient remains in atrial fibrillation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI performed in Normal Sinus Rhythm | Active comparator | Procedure: DCC first then PVIDCC first then PVI |
| PVI performed in Atrial Fibrillation | Active comparator | Procedure: PVI then DCC afterPVI then DCC after if patient remains in Atrial Fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persistent or long standing persistent AF resistant to anti-arrhythmic medication. Must have been present for more than 2 months
- Therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or TEE performed prior to the procedure
- Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control
- Scheduled for Pulmonary Vein Isolation
- Amiodarone will be stopped at least 3 months prior to procedure
Key exclusion criteria (11 listed)
- Reversible causes of AF such as pericarditis, hyperthyroidism
- Presently with Valvular Heart disease requiring surgical intervention
- Presently with coronary artery disease requiring surgical intervention
- Early Post-operative AF (within three months of surgery)
- Previous MAZE or left atrial instrumentation
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 |
|---|---|---|
| DCC first then PVIDCC performed prior to PVI | Procedure or surgery | PVI performed in Normal Sinus Rhythm |
| PVI then DCC afterDCC performed after PVI, if patient remains in Atrial Fibrillation | Procedure or surgery | PVI performed in Atrial Fibrillation |
Primary outcome
Duration of procedure
Time frame: day of procedure
3 secondary outcomes
Composite of duration of fluoroscopy, and radiation exposure doses
Time frame: day of procedure
Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG
Time frame: 12 months
frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG
Time frame: 12 months
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 10 Feb 2017.
- Derived from this study: PubMed 26857909Bassiouny M, Saliba W, Hussein A, Rickard J, Diab M, Aman W, Dresing T, Callahan T 4th, Bhargava M, Martin DO, Shao M, Baranowski B, Tarakji K, Tchou PJ, Hakim A, Kanj M, Lindsay B, Wazni O. Randomized Study of Persistent Atrial Fibrillation Ablation: Ablate in Sinus Rhythm Versus Ablate Complex-Fractionated Atrial Electrograms in Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e003596. doi: 10.1161/CIRCEP.115.003596.
- Individual participant dataSharing planned: No
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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.
Walid Saliba, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCC first then PVI and PVI then DCC after in people with Atrial Fibrillation, run by The Cleveland Clinic 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 5 inclusion and 11 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 10 Feb 2017. 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?
Duration of procedure (time frame: day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429648, which also lists 1 linked publication.
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 10 Feb 2017.