Efficacy Study for Surgery After Previous Failed Catheter Ablation

Surgery After Previous Failed Catheter Ablation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01034852

Acronym

SAVED

Enrollment

Registered

2009-12-18

Start date

2009-05-31

Completion date

2011-01-31

Last updated

2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Ablation

Keywords

Atrial Fibrillation, Maze, Ablation

Brief summary

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

Interventions

PROCEDURETotally Thoracoscopic Maze

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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	1 year post operatively
Record and evaluate all complications associated with the surgical procedure.	1 year post operatively

Secondary

Measure	Time frame
Evaluate usage of anticoagulants at 6 and 12 months.	1 year post operatively
Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.	1 year post operatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026