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Circumferential Versus Ganglionated Plexi Ablation for Atrial Fibrillation (AF)

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ClinicalTrials.gov Identifier: NCT00671905
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Dr D Katritsis, Cardiovascular Research Society, Greece

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: GP ablation Procedure: PV isolation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Circumferential vs Ganglionated Plexi Ablation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Study
Study Start Date : May 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Circumferential PV isolation
Procedure: PV isolation
Circumferential PV isolation

Active Comparator: 2
HF stimulation-guided and anatomic ablation of the main right and left atrial GP.
Procedure: GP ablation
HF stimulation-guided and anatomic ablation of the main right and left atrial GP

Active Comparator: 3
HF stimulation-guided and anatomic ablation of the main right and left atrial GP followed by circumferential PV isolation
Procedure: GP ablation
HF stimulation-guided and anatomic ablation of the main right and left atrial GP

Procedure: PV isolation
Circumferential PV isolation




Primary Outcome Measures :
  1. Freedom of AF or other atrial arrhythmia [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • malignancies
  • LVEF < 35%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671905


Locations
Greece
Athens Euroclinic
Athens, Greece, 11521
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation
Sponsors and Collaborators
Cardiovascular Research Society, Greece
Investigators
Study Director: D Katritsis, MD Cardiovascular Research Society
Principal Investigator: E Pokushalov, MD State Research Institute of Circulation Pathology, Novosibirsk, Russia

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr D Katritsis, Dr Demosthenes Katritsis, MD, PhD(Lon), FRCP, FESC, FACC, Cardiovascular Research Society, Greece
ClinicalTrials.gov Identifier: NCT00671905     History of Changes
Other Study ID Numbers: 1. 25/4/08
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Dr D Katritsis, Cardiovascular Research Society, Greece:
atrial fibrillation
PV isolation
ablation
ganglionic plexi
parasympathetic denervation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes