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OpenTrials
Completed

NCT Number: NCT01794416

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Thoracoscopic epicardial ablation

Procedure

Endocardial catheter ablation

Procedure

Implantable Loop Recorder

Device

Primary outcomes

  1. freedom from any atrial arrhythmia

    Time frame: 12 months

Secondary outcomes

  1. rate of significant adverse events (SAEs)

    Time frame: 12 months

  2. atrial fibrillation burden by ILR

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2013
Registry last updated
Mar 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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