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

Atrial Fibrillation Clinical Trial

— 3DATGvsCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537237
• Other study ID #: 00591
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: November 24, 2014
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: March 2012
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Locations

Country	Name	City	State
United States	St. Elizabeth's Medical Center	Brighton	Massachusetts
United States	Holy Cross Hospital	Fort Lauderdale	Florida

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of procedural success for an ablation procedure using 3DATG fusion	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.	within 6 months	No
Secondary	Overall radiation exposure to the patient	Case report forms were created to capture the exposure each cohort of patients will be subjected to.	Pre-procedure (for CT cohort) to end of procedure	No