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
  Purpose

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.


Condition
Atrial Fibrillation
Arrhythmia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Randomized Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation

Resource links provided by NLM:


Further study details as provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537237

Contacts
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

Locations
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Cheryl Langer, RN    954-229-8557    cheryl.langer@holy-cross.com   
Principal Investigator: Rishi Anand, MD         
United States, Massachusetts
St. Elizabeth's Medical Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Michael V Orlov, MD, PhD, FACC    617-789-3000 ext 2681    michael.orlov@steward.org   
Contact: Lindsay Pothier    617-789-2023    lindsay.pothier@steward.org   
Sub-Investigator: John Wylie, MD         
Sub-Investigator: Shaw Natan, MD         
France
Hopital Cardiologique du Haut-Leveque Not yet recruiting
Bordeaux, France
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
Principal Investigator: Michael V Orlov, MD, PhD St. Elizabeth's Medical Center
  More Information

No publications provided

Responsible Party: Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT01537237     History of Changes
Other Study ID Numbers: 00591
Study First Received: January 3, 2012
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:
Atrial Fibrillation
Catheter-based ablation
Pulmonary vein isolation
Electro-anatomical mapping
Rotational angiography

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014