Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation (3DATGvsCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Steward St. Elizabeth's Medical Center of Boston, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT01537237
First received: January 3, 2012
Last updated: October 12, 2012
Last verified: March 2012

January 3, 2012
October 12, 2012
August 2011
August 2013   (final data collection date for primary outcome measure)
Evidence of procedural success for an ablation procedure using 3DATG fusion [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
Case report forms were created to capture intraprodecure 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.
Evidence of procedural success for an ablation procedure using 3DATG [ Time Frame: within 3 months ] [ Designated as safety issue: No ]
Case report forms were created to capture intraprodecure 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 3 months from the procedure.
Complete list of historical versions of study NCT01537237 on ClinicalTrials.gov Archive Site
Overall radiation exposure to the patient [ Time Frame: Pre-procedure (for CT cohort) to end of procedure ] [ Designated as safety issue: No ]
Case report forms were created to capture the exposure each cohort of patients will be subjected to.
  • Overall radiation exposure time to the patient [ Time Frame: Pre-procedure (for CT cohort) to end of procedure ] [ Designated as safety issue: No ]
    Case report forms were created to capture the amount of time each cohort of patients will be subjected to flouroscopy during CT pre-procedural acquisision and intra-procedural flouroscopy time during creation of the anatomical map.
  • Number of overall hospital visits [ Time Frame: Pre-procedure to 3 months post-procedure ] [ Designated as safety issue: No ]
    Acquiring a CT image for mapping pre-procedure requires an additional hospital visit compared to intraprocedure 3DATG imaging. However, post-procedure uninticipated visits will also be captured and analyzed for procedural success (i.e. reason for hospital visit).
  • Procedural cost [ Time Frame: Pre-procedure to 3 months post-procedure ] [ Designated as safety issue: No ]
    All associated hospital visits will be evaluated. Number and type of hospital visits will be determined by procedure(s) done, time/length of procedure(s) and personnel involved.
Not Provided
Not Provided
 
Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

All patients undergoing a clinically indicated left-sided ablation procedure for atrial fibrillation who therefore satisfy conventional criteria for catheter ablation.

  • Atrial Fibrillation
  • Arrhythmia
Not Provided
  • intra-procedure 3DATG
    Patients who will undergo intra-procedure 3DATG rotational angiography to guide their ablation procedure
  • pre-procedure CT
    Patients who will undergo pre-procedure CT scan to guide their ablation procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Michael V Orlov, MD, PhD 617-789-3000 ext 2681 michael.orlov@steward.org
Contact: Lindsay Pothier 617-789-2023 lindsay.pothier@steward.org
United States,   France
 
NCT01537237
00591
Yes
Steward St. Elizabeth's Medical Center of Boston, Inc.
Steward St. Elizabeth's Medical Center of Boston, Inc.
Not Provided
Principal Investigator: Michael V Orlov, MD, PhD St. Elizabeth's Medical Center
Steward St. Elizabeth's Medical Center of Boston, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP