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NCT01794416 Clinical Trial

Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Thoracoscopic Ablation Versus Endocardial Ablation in Patient With Paroxysmal Atrial Fibrillation After Failed Initial Endocardial Ablation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01794416
Other study ID # TA-EA-001
Secondary ID
Status Completed
Phase Phase 2
First received February 15, 2013
Last updated March 24, 2013
Start date May 2011
Est. completion date March 2013

Study information
Verified date March 2013
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

The investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- failed initial catheter ablation

- paroxysmal atrial fibrillation

Exclusion Criteria:

- chronic lung disease

- body mass index >35

- longstanding atrial fibrillation 1 year

- previous stroke or transient ischemic attack

- left atrial thrombus

- left atrial size >65 mm

- left ventricular ejection fraction <35%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Thoracoscopic epicardial ablation

• Endocardial catheter ablation

Device:
• Implantable loop recorder

Locations
Country Name City State
Russian Federation State Research Institute of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary freedom from any atrial arrhythmia 12 months Yes
Secondary rate of significant adverse events (SAEs) 12 months Yes
Secondary atrial fibrillation burden by ILR 12 months Yes
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