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OpenTrials
Completed

NCT Number: NCT01034852

Efficacy Study for Surgery After Previous Failed Catheter Ablation

Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.

Primary Objectives:

1. Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF 2. Record and evaluate all complications associated with the surgical procedure.

Secondary Objectives:

1. Evaluate usage of anticoagulants at 6, and 12 months. 2. Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endovascular Research, Springfield, Oregon, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of atrial fibrillation
  • Has undergone one or more catheter based ablation procedures for AF and the procedure failed
  • Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF

Treatment and study plan

Totally Thoracoscopic Maze

Procedure

Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician

Other names: Minimally invasive maze, Cox Maze procedure

Primary outcomes

  1. Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF.

    Time frame: 1 year post operatively

  2. Record and evaluate all complications associated with the surgical procedure.

    Time frame: 1 year post operatively

Secondary outcomes

  1. Evaluate usage of anticoagulants at 6 and 12 months.

    Time frame: 1 year post operatively

  2. Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.

    Time frame: 1 year post operatively

Sponsors and collaborators

Lead sponsor

Cardiopulmonary Research Science and Technology Institute

Other

Collaborators

  • AtriCure, Inc.
  • Virginia Commonwealth University

Registry information

Official study title

Surgery After Previous Failed Catheter Ablation

Acronym: SAVED

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 18, 2009
Registry last updated
Feb 22, 2012

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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