Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Medisch Spectrum Twente
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Recurrence of AF
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
VATS therapy
Intervention: VATS-PVI (Procedure)
Percutaneous therapy
Intervention: PVI (Procedure)
Outcomes
Primary Outcomes
Recurrence of AF
Time Frame: one year
The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.
Secondary Outcomes
- Treatment impact(one year)
Investigators
B. Oude Velthuis
B. Oude Velthuis MD
Medisch Spectrum Twente