Atrial FibrillationCONTROL-AFNCT01360918
Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
A study testing Epicardial pulmonary vein isolation in people with Atrial Fibrillation, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial summary
Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Epicardial pulmonary vein isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to May 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- EHRA class ≤ 2
- Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
- Patients will have elective coronary surgery planned Able of providing informed consent
Who cannot join
- Patients ≥70 years of age
- Pregnancy Patients with contraindications for oral anticoagulant agents
- Patients undergoing emergency operation
- Patients undergoing concomitant valve replacement
- Severely enlarged LA (>50 mm) on echocardiography
- Prior AF ablation or AF surgery
Trial locations and contacts
1 site in 1 country.
About this study
Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.
- Conditions
- Atrial Fibrillation
- Being tested
- Epicardial pulmonary vein isolation, Usual care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial pulmonary vein isolationDevice
Also called Medtronic Cardioblate BP2
After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.
Usual careOther
Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Not described Receives: Other: Usual care |
| Pulmonary vein isolation | Active comparator | Not described Receives: Device: Epicardial pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.
Measured: one year
Secondary outcomes (1)
Duration of hospitalization
Secondary objectives include the duration of hospitalization
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2014
Why it stopped: Inclusion rate insufficiënt
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
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Cardiovascular Research and Education Enschede
- Responsible party
- Principal investigator, B. Oude Velthuis, Medisch Spectrum Twente
- Investigators
- Marcoen Scholten, MD PhD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360918
- Sponsor's protocol ID
- NL35192.044.11
- Acronym
- CONTROL-AF
- Status last verified
- Jul 2016
- First submitted
- 13 May 2011
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01360918
- Acronym / sponsor ID
- CONTROL-AF / NL35192.044.11
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rate insufficiënt
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- Foundation of Cardiovascular Research and Education Enschede
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 May 2011 (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.
Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual care |
| Pulmonary vein isolation | Active comparator | Device: Epicardial pulmonary vein isolation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age
- EHRA class ≤ 2
- Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
- Patients will have elective coronary surgery planned Able of providing informed consent
Key exclusion criteria (6 listed)
- Patients ≥70 years of age
- Pregnancy Patients with contraindications for oral anticoagulant agents
- Patients undergoing emergency operation
- Patients undergoing concomitant valve replacement
- Severely enlarged LA (>50 mm) on echocardiography
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 |
|---|---|---|
| Epicardial pulmonary vein isolationAlso: Medtronic Cardioblate BP2After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation. | Device | Pulmonary vein isolation |
| Usual careManagement of atrial fibrillation according to current guidelines using rate control pharmacological therapy. | Other | Usual care |
Primary outcome
Recurrence of atrial fibrillation
Time frame: one year
The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.
1 secondary outcome
Duration of hospitalization
Time frame: One year
Results and safety
The study was stopped early (reason given: Inclusion rate insufficiënt). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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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.
Marcoen Scholten, MD PhD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epicardial pulmonary vein isolation in people with Atrial Fibrillation, run by Medisch Spectrum Twente at 1 site in Netherlands.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Jul 2016. 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 Netherlands. 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 was stopped early (reason given: Inclusion rate insufficiënt). 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?
Recurrence of atrial fibrillation (time frame: one year). 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 7 Jul 2016.