Paroxysmal Atrial FibrillationFIN-PVINCT01791218
Surgical Pulmonary Vein Isolation Efficiency Study
A study testing CABG, AVR or CABG+AVR and PVI and CABG, AVR or CABG+AVR in people with Paroxysmal Atrial Fibrillation and Coronary Artery Disease, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- CABG, AVR or CABG+AVR and PVI and CABG, AVR or CABG+AVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2012to Sep 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
- At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months
- Duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion
- written and verbal consent
Who cannot join
- Prior cardiac surgery
- Active pacemaker treatment
- Active anti-arrhythmic treatment(AAD) class I and III
- Contraindication to oral anticoagulant/heparin treatment
- Ejection fraction less than 30 % (EF < 30 %)assessed by transthoracic echocardiography
- Left atrial diameter less than 55mm assessed by transthoracic echocardiography
Show all 9Show fewer
- Renal insufficiency requiring dialysis
- Heart valve disease requiring invasive treatment
- Heart anomaly requiring regular controls and/or invasive treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting and Aortic Valve Replacement for Aortic Stenosis: a Prospective Study
A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.
There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.
- Being tested
- CABG, AVR or CABG+AVR and PVI, CABG, AVR or CABG+AVR
- Keywords
- Pulmonary vein isolation, Paroxysmal atrial fibrillation, Quality of life
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG, AVR or CABG+AVR and PVIProcedure or surgery
CABG, AVR or CABG+AVRProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CABG, AVR or CABG+AVR and PVI | Experimental | Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis (AVR) or combination (CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation (PVI) in CBP prior to occlusion and CABG Receives: Procedure: CABG, AVR or CABG+AVR and PVI |
| CABG, AVR or CABG+AVR | Active comparator | Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis(AVR) or combination(CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. No operative procedures for the treatment of atrial fibrillation Receives: Procedure: CABG, AVR or CABG+AVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation burden
Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring
Measured: Within one year after operative treatment
Freedom of symptomatic and asymptomatic atrial fibrillation after surgery
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds.
Freedom of atrial fibrillation is defined as duration of atrial fibrillation less than 0,5% of the one week Holter monitoring
Measured: Within one year after operative treatment
Secondary outcomes (6)
Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation
Measured: Within one year after operative treatment
Adverse events after surgery in both arms
Measured: Within one year after operative treatment
Anti-arrhythmic treatment after surgery
Measured: Within one year after treatment
Hospitalization due to atrial fibrillation after surgery
Measured: Within one year after operative treatment
Cardioversion for the treatment of atrial fibrillation after surgery
Measured: Within one year after operative treatment
Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding
Measured: Within one year after operative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2020
- Study completionSep 2020
Why it stopped: Not enough patients for study arms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791218
- Sponsor's protocol ID
- KUH5101071
- Acronym
- FIN-PVI
- Status last verified
- Sep 2020
- First submitted
- 12 Feb 2013
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting and Aortic Valve Replacement for Aortic Stenosis: a Prospective Study
- ClinicalTrials.gov ID
- NCT01791218
- Acronym / sponsor ID
- FIN-PVI / KUH5101071
- Keywords
- Pulmonary vein isolation, Paroxysmal atrial fibrillation, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients for study arms
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 13 Feb 2013 (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.
A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.
There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG, AVR or CABG+AVR and PVI | Experimental | Procedure: CABG, AVR or CABG+AVR and PVICoronary artery bypass (CABG), aortic valve replacement for aortic stenosis (AVR) or combination (CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation (PVI) in CBP prior to occlusion and CABG |
| CABG, AVR or CABG+AVR | Active comparator | Procedure: CABG, AVR or CABG+AVRCoronary artery bypass (CABG), aortic valve replacement for aortic stenosis(AVR) or combination(CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. No operative procedures for the treatment of atrial fibrillation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
- At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months
- Duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion
- written and verbal consent
Key exclusion criteria (9 listed)
- Prior cardiac surgery
- Active pacemaker treatment
- Active anti-arrhythmic treatment(AAD) class I and III
- Contraindication to oral anticoagulant/heparin treatment
- Ejection fraction less than 30 % (EF < 30 %)assessed by transthoracic 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 |
|---|---|---|
| CABG, AVR or CABG+AVR and PVI | Procedure or surgery | CABG, AVR or CABG+AVR and PVI |
| CABG, AVR or CABG+AVR | Procedure or surgery | CABG, AVR or CABG+AVR |
Primary outcome
Atrial fibrillation burden
Time frame: Within one year after operative treatment
Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring
Freedom of symptomatic and asymptomatic atrial fibrillation after surgery
Time frame: Within one year after operative treatment
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Freedom of atrial fibrillation is defined as duration of atrial fibrillation less than 0,5% of the one week Holter monitoring
6 secondary outcomes
Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation
Time frame: Within one year after operative treatment
Adverse events after surgery in both arms
Time frame: Within one year after operative treatment
Anti-arrhythmic treatment after surgery
Time frame: Within one year after treatment
Hospitalization due to atrial fibrillation after surgery
Time frame: Within one year after operative treatment
Cardioversion for the treatment of atrial fibrillation after surgery
Time frame: Within one year after operative treatment
Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding
Time frame: Within one year after operative treatment
Results and safety
The study was stopped early (reason given: Not enough patients for study arms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Related trials for Paroxysmal Atrial Fibrillation
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Recruiting
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Not yet recruiting
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
Recruiting
Feasibility Study of the FARAFLEX Mapping and PFA System
Atrial Fibrillation, Persistent 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CABG, AVR or CABG+AVR and PVI and CABG, AVR or CABG+AVR in people with Paroxysmal Atrial Fibrillation and Coronary Artery Disease, run by Kuopio University Hospital at 1 site in Finland.
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 9 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 2 Sep 2020. 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 Finland. 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: Not enough patients for study arms). 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 burden (time frame: Within one year after operative treatment). The study lists 2 primary outcomes in all. 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 2 Sep 2020.