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Completed

NCT Number: NCT01537237

Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation

The purpose of this study is to compare rotational angiography (3DATG technology)intra-procedure (during the ablation procedure) with CT (x-ray) pre-procedure (before the ablation procedure) fusion to create an anatomical picture of a heart to help adequately guide an ablation procedure for patients with arrhythmias.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holy Cross Hospital, Fort Lauderdale, Florida, United States

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About this study

Rotational angiography (or three dimensional arteriography or "3DATG") is a new tool used to guide atrial fibrillation (AF) ablation. The current approach to imaging for AF ablation involves obtaining a computer tomography (CT) angiogram of the atrium pre-procedure and combining it with an electro-anatomical map, a process called merging or overlay. The investigators propose to investigate the quality of the 3DATG as a replacement for the CT in obtaining a left atrial angiogram (to guide AF ablation).

All imaging modalities to be evaluated in this study are currently used in clinical practice. They are not experimental methods. The goal is to compare two modalities that have never been directly compared before. The CT angiography utilizes a standard CT scanner and intravenously injected contrast agent to visualize the left atrium. While the 3DATG is a method that achieves similar results to a CT scanner, the difference is that the 3DATG images are acquired by rotating the X-ray source around the patient on a C-arm instead of a dedicated CT scanner.

60 participants will be consented and randomized to either pre-procedure CT or intra-procedure 3DATG. Scheduled participants will undergo sedation and catheter instrumentation as appropriate. CT anatomy data will then be merged with the live X-ray via the EP Navigator system in standard fashion or the patient will be prepped for appropriate 3DATG anatomy data acquisition and merged with the EP Navigator system. The EP Navigator system will then be used to send either data to NavX or CARTO to create the intended electro-anatomical map.

Using the CT or 3DATG acquired electro-anatomical map, the ablation procedure will be conducted in the same way as would the local practice and standard of care for any patient not participating in the study.

The ablation procedure and the sites of ablation lesions will be tagged on the 3D overlaid anatomy in the same fashion as previously published and all participants will be followed as routine at a 1 month and 3 month follow up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients undergoing a clinically indicated left-sided ablation procedure for atrial fibrillation

Exclusion criteria

  • Patients not willing or able to provide consent to participate or already involved in another clinical trial.

Treatment and study plan

Primary outcomes

  1. Evidence of procedural success for an ablation procedure using 3DATG fusion

    Time frame: within 6 months

    Case report forms were created to capture intraprocedure data (i.e.noticeable map drift) of the maps created and used to create ablation lesions. Procedure user's overall clinical evaluation (i.e.feedback) and experience (i.e. radiation time, number of mapping points collected per map, mapping time) will also be collected and analyzed. And patients will be followed as routine for overall disease evaluation (i.e. ECG and patient reported symptoms) within 6 months from the procedure.

Secondary outcomes

  1. Overall radiation exposure to the patient

    Time frame: Pre-procedure (for CT cohort) to end of procedure

    Case report forms were created to capture the exposure each cohort of patients will be subjected to.

Sponsors and collaborators

Lead sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

Other

Registry information

Official study title

Randomized Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation

Acronym: 3DATGvsCT

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 23, 2012
Registry last updated
Nov 25, 2014

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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