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A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation

Primary Purpose

Atrial Fibrillation, Arrhythmia

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Catheter ablation (pulmonary vein isolation)

About this trial

This is an interventional educational/counseling/training trial for Atrial Fibrillation focused on measuring Catheter ablation, Atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: symptomatic paroxysmal or persistent AF for more than 6 months, with at least 3 episodes in 3 months and with insufficient effect of at least 2 pharmacological regimens Exclusion Criteria: congenital heart disease age under 18 years significant valve disease left atrial size > 55 mm prior ablation for AF Severe heart failure (LVEF < 20 % and/or NYHA class IV)

Sites / Locations

Righospitalet, Copenhagen University Hospital

Outcomes

Primary Outcome Measures

overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)

Secondary Outcome Measures

- safety

- resumption of LA-PV conduction

- neurohormones

- socio-economics (cost effectiveness)

- inflammatory markers

- quality of life

- signal averaged P wave signals-

Full Information

NCT ID

NCT00192972

First Posted

September 12, 2005

Last Updated

December 21, 2005

Sponsor

Rigshospitalet, Denmark

Collaborators

Medtronic, Biosense Webster, Inc., Abbott Medical Devices, Guidant Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00192972

Brief Title

A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation

Official Title

A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2003

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Medtronic, Biosense Webster, Inc., Abbott Medical Devices, Guidant Corporation

4. Oversight

5. Study Description

Brief Summary

Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation. In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.

Detailed Description

Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation. In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure. Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction. Secondary endpoints were: safety resumption of LA-PV conduction alterations in neurohormones socio-economics aspects(cost effectiveness) changes in inflammatory markers quality of life alterations in signal averaged P wawe signals evaluation of the predictive value of these variables to predict recurrence of AF

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Arrhythmia

Keywords

Catheter ablation, Atrial fibrillation

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Catheter ablation (pulmonary vein isolation)

Primary Outcome Measure Information:

Title

overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)

Secondary Outcome Measure Information:

Title

- safety

Title

- resumption of LA-PV conduction

Title

- neurohormones

Title

- socio-economics (cost effectiveness)

Title

- inflammatory markers

Title

- quality of life

Title

- signal averaged P wave signals-

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: