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Status unknownNCT03857711PULVABUpdated Feb 6, 2020

Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

An interventional study of Conventional CABG and CABG+ PVI in Arrhythmias, Cardiac, Cardiovascular Diseases and Postoperative Atrial Fibrillation, sponsored by National Research Center of Surgery, Russia. Status unknown at 2 sites in Russian Federation. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by National Research Center of Surgery, Russia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Arrhythmias, Cardiac
  • Cardiovascular Diseases
  • Postoperative Atrial Fibrillation
  • Myocardial Ischemia

Keywords

  • Bipolar radiofrequency ablation
  • Atrial Fibrillation New Onset
  • CABG
  • Coronary artery disease
  • Postoperative atrial fibrillation
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 280 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

National Research Center of Surgery, Russia is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients must have signed an informed consent.
  • patients had indications for two or more coronary arteries to be bypassed
  • no history of AF

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Active comparator
    Conventional CABG

    Coronary artery bypass grafting (CABG) treatment (CABG group,n=70)

    Procedure: Conventional CABG

  • Active comparator
    CABG+ PVI

    CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70)

    Procedure: CABG+ PVI

  • Active comparator
    CABG+ PVI+amiodarone

    CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70)

    Procedure: CABG+ PVI+amiodarone

  • Active comparator
    CABG+amiodarone

    CABG+class III antiarrhythmic drug- amiodarone, group, n=70

    Procedure: CABG+amiodarone

Interventions

  • ProcedureConventional CABG

    Coronary artery bypass grafting

  • ProcedureCABG+ PVI

    CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins

  • ProcedureCABG+ PVI+amiodarone

    CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)

  • ProcedureCABG+amiodarone
06

What researchers measure

Primary outcomes

  1. Incidence of atrial fibrillation after CABG

    Time frame: Through study completion, an average of 1 year

  2. 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

Secondary outcomes

  1. Sinus rhythm at the time of discharge of the patient from the hospital

    Time frame: Through study completion, an average of 1 year

  2. Duration of mechanical ventilation

    Time frame: Through study completion, an average of 1 year

  3. Incidence of implantation of the pacemaker

    Time frame: Through study completion, an average of 1 year

  4. Volume of intraoperative bleeding

    Time frame: Through study completion, an average of 1 year

  5. Time of CBP

    Time frame: Through study completion, an average of 1 year

  6. Time clamping of the aorta

    Time frame: Through study completion, an average of 1 year

  7. Length of stay in the intensive care unit

    Time frame: Through study completion, an average of 1 year

  8. Duration of the hospitalization

    Time frame: Through study completion, an average of 1 year

07

Study locations

2 of 2 sites recruiting
  • Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
    Kaliningrad, 236035, Russian Federation
    • Yuri A Schneider · Contact
    • Yuri A Schneider · Principal investigator
    Recruiting
  • A.V. Vishnevsky National Medical Research Center of Surgery.
    Moscow, 117997, Russian Federation
    • Amiran Sh. Revishvili · Contact · +7 (499) 236-72-90
    • Vadim A. Popov · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03857711
Lead sponsor
National Research Center of Surgery, Russia
Collaborators
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
Responsible party
Stepanova Yulia Aleksandrovna (Clinical Professor, National Research Center of Surgery, Russia) — Principal investigator
First posted
Feb 28, 2019
Start date
Sep 1, 2016
Primary completion
Dec 1, 2016
Completion
Dec 1, 2022 (estimated)
Last update
Feb 6, 2020

Study contacts

Amiran Sh. Revishvili
Contact
+7 (499) 236-72-90
Vadim A. Popov
Contact
drpopov@mail.ru
+7 9166706609
Amiran Sh. Revishvili
study chair · A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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