NCT00671905

Brief Summary

The investigators have recently shown that anatomic ganglionated plexi (GP) ablation is inferior to circumferential pulmonary vein (PV) ablation for the treatment of paroxysmal AF. In this study, however, 26% of patients subjected to GP ablation alone without circumferential lesions were free of AF-recurrence up to one year after the ablation procedure. The investigators hypothesized that a combination of circumferential ablation with high-frequency-stimulation-identified GP ablation is superior to conventional circumferential ablation for the prevention of recurrences of paroxysmal atrial fibrillation (AF). The investigators are, therefore, conducting a randomized study comparing conventional circumferential ablation to a combination of circumferential ablation plus specific right and left atrial GP ablation in patients with drug-refractory paroxysmal AF.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2008

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

3 years

First QC Date

April 30, 2008

Last Update Submit

April 10, 2013

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationPV isolationablationganglionic plexiparasympathetic denervation

Outcome Measures

Primary Outcomes (1)

  • Freedom of AF or other atrial arrhythmia

    2 years

Secondary Outcomes (1)

  • Quality of life

    2 years

Study Arms (3)

1

ACTIVE COMPARATOR

Circumferential PV isolation

Procedure: PV isolation

2

ACTIVE COMPARATOR

HF stimulation-guided and anatomic ablation of the main right and left atrial GP.

Procedure: GP ablation

3

ACTIVE COMPARATOR

HF stimulation-guided and anatomic ablation of the main right and left atrial GP followed by circumferential PV isolation

Procedure: GP ablationProcedure: PV isolation

Interventions

GP ablationPROCEDURE

HF stimulation-guided and anatomic ablation of the main right and left atrial GP

23
PV isolationPROCEDURE

Circumferential PV isolation

13

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • paroxysmal AF
  • age \< 75 years
  • left atrial size \< 5 cm

You may not qualify if:

  • malignancies
  • LVEF \< 35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Athens Euroclinic

Athens, 11521, Greece

Location

State Research Institute of Circulation Pathology

Novosibirsk, Russia

Location

Related Publications (13)

  • Scanavacca M, Pisani CF, Hachul D, Lara S, Hardy C, Darrieux F, Trombetta I, Negrao CE, Sosa E. Selective atrial vagal denervation guided by evoked vagal reflex to treat patients with paroxysmal atrial fibrillation. Circulation. 2006 Aug 29;114(9):876-85. doi: 10.1161/CIRCULATIONAHA.106.633560. Epub 2006 Aug 21.

    PMID: 16923757BACKGROUND

  • Schauerte P, Scherlag BJ, Pitha J, Scherlag MA, Reynolds D, Lazzara R, Jackman WM. Catheter ablation of cardiac autonomic nerves for prevention of vagal atrial fibrillation. Circulation. 2000 Nov 28;102(22):2774-80. doi: 10.1161/01.cir.102.22.2774.

    PMID: 11094046BACKGROUND

  • Lemola K, Chartier D, Yeh YH, Dubuc M, Cartier R, Armour A, Ting M, Sakabe M, Shiroshita-Takeshita A, Comtois P, Nattel S. Pulmonary vein region ablation in experimental vagal atrial fibrillation: role of pulmonary veins versus autonomic ganglia. Circulation. 2008 Jan 29;117(4):470-7. doi: 10.1161/CIRCULATIONAHA.107.737023. Epub 2008 Jan 14.

    PMID: 18195170BACKGROUND

  • McClelland JH, Duke D, Reddy R. Preliminary results of a limited thoracotomy: new approach to treat atrial fibrillation. J Cardiovasc Electrophysiol. 2007 Dec;18(12):1289-95. doi: 10.1111/j.1540-8167.2007.00977.x. Epub 2007 Oct 5.

    PMID: 17919294BACKGROUND

  • Nakagawa H, Jackman WM, Scherlag BJ, Lazzara R. Pulmonary vein isolation during atrial fibrillation: insight into the mechanism of pulmonary vein firing. J Cardiovasc Electrophysiol. 2003 Mar;14(3):261-2. doi: 10.1046/j.1540-8167.2003.03002.x. No abstract available.

    PMID: 12716107BACKGROUND

  • Pappone C, Santinelli V, Manguso F, Vicedomini G, Gugliotta F, Augello G, Mazzone P, Tortoriello V, Landoni G, Zangrillo A, Lang C, Tomita T, Mesas C, Mastella E, Alfieri O. Pulmonary vein denervation enhances long-term benefit after circumferential ablation for paroxysmal atrial fibrillation. Circulation. 2004 Jan 27;109(3):327-34. doi: 10.1161/01.CIR.0000112641.16340.C7. Epub 2004 Jan 5.

    PMID: 14707026BACKGROUND

  • Oh S, Zhang Y, Bibevski S, Marrouche NF, Natale A, Mazgalev TN. Vagal denervation and atrial fibrillation inducibility: epicardial fat pad ablation does not have long-term effects. Heart Rhythm. 2006 Jun;3(6):701-8. doi: 10.1016/j.hrthm.2006.02.020. Epub 2006 Mar 6.

    PMID: 16731474BACKGROUND

  • Hirose M, Leatmanoratn Z, Laurita KR, Carlson MD. Partial vagal denervation increases vulnerability to vagally induced atrial fibrillation. J Cardiovasc Electrophysiol. 2002 Dec;13(12):1272-9. doi: 10.1046/j.1540-8167.2002.01272.x.

    PMID: 12521345BACKGROUND

  • Cummings JE, Gill I, Akhrass R, Dery M, Biblo LA, Quan KJ. Preservation of the anterior fat pad paradoxically decreases the incidence of postoperative atrial fibrillation in humans. J Am Coll Cardiol. 2004 Mar 17;43(6):994-1000. doi: 10.1016/j.jacc.2003.07.055.

    PMID: 15028356BACKGROUND

  • Pokushalov E, Turov A, Shugayev P, Artyomenko S, Romanov A, Shirokova N. Catheter ablation of left atrial ganglionated plexi for atrial fibrillation. Asian Cardiovasc Thorac Ann. 2008 Jun;16(3):194-201. doi: 10.1177/021849230801600304.

    PMID: 18515667BACKGROUND

  • Katritsis D, Giazitzoglou E, Sougiannis D, Goumas N, Paxinos G, Camm AJ. Anatomic approach for ganglionic plexi ablation in patients with paroxysmal atrial fibrillation. Am J Cardiol. 2008 Aug 1;102(3):330-4. doi: 10.1016/j.amjcard.2008.03.062. Epub 2008 May 22.

    PMID: 18638596BACKGROUND

  • Katritsis DG, Pokushalov E, Romanov A, Giazitzoglou E, Siontis GC, Po SS, Camm AJ, Ioannidis JP. Autonomic denervation added to pulmonary vein isolation for paroxysmal atrial fibrillation: a randomized clinical trial. J Am Coll Cardiol. 2013 Dec 17;62(24):2318-25. doi: 10.1016/j.jacc.2013.06.053. Epub 2013 Aug 21.

    PMID: 23973694DERIVED

  • Katritsis DG, Giazitzoglou E, Zografos T, Pokushalov E, Po SS, Camm AJ. Rapid pulmonary vein isolation combined with autonomic ganglia modification: a randomized study. Heart Rhythm. 2011 May;8(5):672-8. doi: 10.1016/j.hrthm.2010.12.047. Epub 2010 Dec 31.

    PMID: 21199686DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • D Katritsis, MD

    Cardiovascular Research Society

    STUDY DIRECTOR

  • E Pokushalov, MD

    State Research Institute of Circulation Pathology, Novosibirsk, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Demosthenes Katritsis, MD, PhD(Lon), FRCP, FESC, FACC

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 5, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

RU(1)GR(1)