Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2015 |
Start Date: | August 2011 |
End Date: | September 2013 |
Contact: | Michael V Orlov, MD, PhD |
Email: | michael.orlov@steward.org |
Phone: | 617-789-3000 |
Randomized 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.
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.
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.
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.
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.
We found this trial at
2
sites
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