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Circumferential Versus Ganglionated Plexi Ablation for Atrial Fibrillation (AF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr D Katritsis, Cardiovascular Research Society, Greece
ClinicalTrials.gov Identifier:
NCT00671905
First received: April 30, 2008
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Atrial Fibrillation
 Procedure: GP ablation
Procedure: PV isolation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Circumferential vs Ganglionated Plexi Ablation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiovascular Research Society, Greece:

Primary Outcome Measures:
  • Freedom of AF or other atrial arrhythmia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: May 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • malignancies
  • LVEF < 35%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Additional 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
Study First Received: April 30, 2008
Last Updated: April 10, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013