Arrhythmias, CardiacPULVABNCT03857711
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
A study testing Conventional CABG, CABG+ PVI and CABG+ PVI+amiodarone in people with Arrhythmias, Cardiac and Cardiovascular Diseases, run by National Research Center of Surgery, Russia at 2 sites in Russia.
Trial summary
To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Arrhythmias, Cardiac, Cardiovascular Diseases, Postoperative Atrial Fibrillation
- What is being tested?
- Conventional CABG, CABG+ PVI and CABG+ PVI+amiodarone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Sep 2016to 1 Dec 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients must have signed an informed consent.
- patients had indications for two or more coronary arteries to be bypassed
- no history of AF
Who cannot join
- acute coronary syndrome
- previous CABG.
- a significant decrease in the contractile function of the heart (EF <40%)
- significant heart valve disease requiring surgical repair
- long-standing persistent, persistent, or paroxysmal forms of atrial fibrillation
- respiratory failure
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- left ventricular aneurysm requiring surgical correction
- chronic renal failure (≤60 mL/min/1⋅73 m2)
- chronic diseases that make a significant contribution to the prognosis of life (e.g. oncology)
- participation in other clinical trials
Trial locations and contacts
2 sites in 1 country.
Amiran Sh. Revishvili contact
Russia2 sites, 2 recruiting
- Recruiting
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
Kaliningrad, 236035
Yuri A Schneider
Yuri A Schneider
- Recruiting
A.V. Vishnevsky National Medical Research Center of Surgery.
Moscow, 117997
Amiran Sh. Revishvili, +7 (499) 236-72-90
Vadim A. Popov
About this study
Official title: Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.
Read the detailed description
Prospective, multicenter, randomized trial, intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation.
The study includes 4 groups of patients:
Group I (conventional CABG)
Group II (CABG + pulmonary veins isolation). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation.
Group III (CABG+ pulmonary veins isolation + amiodarone). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode.
Group IV (CABG+ amiodarone). Conventional CABG with administration of amiodarone in postoperative periode.
- Conditions
- Arrhythmias, Cardiac, Cardiovascular Diseases, Postoperative Atrial Fibrillation, Myocardial Ischemia
- Being tested
- Conventional CABG, CABG+ PVI, CABG+ PVI+amiodarone, CABG+amiodarone
- Keywords
- Bipolar radiofrequency ablation, Atrial Fibrillation New Onset, CABG, Coronary artery disease, Postoperative atrial fibrillation
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional CABGProcedure or surgery
Coronary artery bypass grafting
CABG+ PVIProcedure or surgery
CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins
CABG+ PVI+amiodaroneProcedure or surgery
CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)
CABG+amiodaroneProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Conventional CABG | Active comparator | Coronary artery bypass grafting (CABG) treatment (CABG group,n=70) Receives: Procedure: Conventional CABG |
| CABG+ PVI | Active comparator | CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70) Receives: Procedure: CABG+ PVI |
| CABG+ PVI+amiodarone | Active comparator | CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70) Receives: Procedure: CABG+ PVI+amiodarone |
| CABG+amiodarone | Active comparator | CABG+class III antiarrhythmic drug- amiodarone, group, n=70 Receives: Procedure: CABG+amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation after CABG
Measured: Through study completion, an average of 1 year
Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Sinus rhythm at the time of discharge of the patient from the hospital
Measured: Through study completion, an average of 1 year
Duration of mechanical ventilation
Measured: Through study completion, an average of 1 year
Incidence of implantation of the pacemaker
Measured: Through study completion, an average of 1 year
Volume of intraoperative bleeding
Measured: Through study completion, an average of 1 year
Time of CBP
Measured: Through study completion, an average of 1 year
Time clamping of the aorta
Measured: Through study completion, an average of 1 year
Length of stay in the intensive care unit
Measured: Through study completion, an average of 1 year
Duration of the hospitalization
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Sep 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center of Surgery, Russia
- Sponsor type
- Other government
- Collaborators
- Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
- Responsible party
- Principal investigator, Stepanova Yulia Aleksandrovna, National Research Center of Surgery, Russia
- Investigators
- Amiran Sh. Revishvili, Study chair, A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857711
- Sponsor's protocol ID
- q9ics7t8
- Acronym
- PULVAB
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
- ClinicalTrials.gov ID
- NCT03857711
- Acronym / sponsor ID
- PULVAB / q9ics7t8
- Conditions
- Arrhythmias, Cardiac, Cardiovascular Diseases, Postoperative Atrial Fibrillation, Myocardial Ischemia
- Keywords
- Bipolar radiofrequency ablation, Atrial Fibrillation New Onset, CABG, Coronary artery disease, Postoperative atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- National Research Center of Surgery, RussiaOther government
- Collaborators
- Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
- Study start
- 1 Sep 2016
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Feb 2019 (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.
To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.
Detailed description
Prospective, multicenter, randomized trial, intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation.
The study includes 4 groups of patients:
Group I (conventional CABG)
Group II (CABG + pulmonary veins isolation). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation.
Group III (CABG+ pulmonary veins isolation + amiodarone). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode.
Group IV (CABG+ amiodarone). Conventional CABG with administration of amiodarone in postoperative periode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional CABG | Active comparator | Procedure: Conventional CABGCoronary artery bypass grafting (CABG) treatment (CABG group,n=70) |
| CABG+ PVI | Active comparator | Procedure: CABG+ PVICABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70) |
| CABG+ PVI+amiodarone | Active comparator | Procedure: CABG+ PVI+amiodaroneCABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70) |
| CABG+amiodarone | Active comparator | Procedure: CABG+amiodaroneCABG+class III antiarrhythmic drug- amiodarone, group, n=70 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients must have signed an informed consent.
- patients had indications for two or more coronary arteries to be bypassed
- no history of AF
Key exclusion criteria (10 listed)
- acute coronary syndrome
- previous CABG.
- a significant decrease in the contractile function of the heart (EF <40%)
- significant heart valve disease requiring surgical repair
- long-standing persistent, persistent, or paroxysmal forms of atrial fibrillation
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 |
|---|---|---|
| Conventional CABGCoronary artery bypass grafting | Procedure or surgery | Conventional CABG |
| CABG+ PVICABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins | Procedure or surgery | CABG+ PVI |
| CABG+ PVI+amiodaroneCABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone) | Procedure or surgery | CABG+ PVI+amiodarone |
| CABG+amiodarone | Procedure or surgery | CABG+amiodarone |
Primary outcome
Incidence of atrial fibrillation after CABG
Time frame: Through study completion, an average of 1 year
Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.
Time frame: Through study completion, an average of 1 year
8 secondary outcomes
Sinus rhythm at the time of discharge of the patient from the hospital
Time frame: Through study completion, an average of 1 year
Duration of mechanical ventilation
Time frame: Through study completion, an average of 1 year
Incidence of implantation of the pacemaker
Time frame: Through study completion, an average of 1 year
Volume of intraoperative bleeding
Time frame: Through study completion, an average of 1 year
Time of CBP
Time frame: Through study completion, an average of 1 year
Time clamping of the aorta
Time frame: Through study completion, an average of 1 year
Length of stay in the intensive care unit
Time frame: Through study completion, an average of 1 year
Duration of the hospitalization
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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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.
Amiran Sh. Revishvili contact
Amiran Sh. Revishvili study chair
A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional CABG, CABG+ PVI and CABG+ PVI+amiodarone in people with Arrhythmias, Cardiac and Cardiovascular Diseases, run by National Research Center of Surgery, Russia at 2 sites in Russia.
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 10 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 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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?
Contact Amiran Sh. Revishvili (+7 (499) 236-72-90), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial fibrillation after CABG (time frame: Through study completion, an average of 1 year). 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 6 Feb 2020.