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Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial (VATCAT)

M

Medisch Spectrum Twente

Status

Terminated

Conditions

Atrial Fibrillation

Treatments

Procedure: VATS-PVI
Procedure: PVI

Study type

Interventional

Funder types

Other

Identifiers

NCT01319747
NL32865.044.10
Dutch trial register entry (Registry Identifier)
32865 (Other Identifier)

Details and patient eligibility

About

Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both interventions are limited.

The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalization, quality of Life, cost and to compare the satisfaction of the patients.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients > 18 years of age
  • Documented, symptomatic, episodes of paroxysmal or persistent AF
  • During the last 6 months patients must have at least 2 documented episodes of AF, despite the use of at least 1 anti arrhythmic drug.
  • Able of providing informed consent

Exclusion criteria

  • Pregnancy
  • Unwillingness to use or contra-indications for vitamin K antagonists
  • Severely enlarged left atrium (>50 mm) on echocardiography
  • Prior AF ablation or AF surgery
  • Intracardiac thrombus
  • Prior heart surgery or pulmonary disease hampering thoracoscopic surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

77 participants in 2 patient groups

Percutaneous therapy
Active Comparator group
Treatment:
Procedure: PVI
VATS therapy
Active Comparator group
Treatment:
Procedure: VATS-PVI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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