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

NCT01537237 | Completed DMC

• 1 other identifier: 00591
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation; Arrhythmia

Keywords

Atrial Fibrillation; Catheter-based ablation; Pulmonary vein isolation; Electro-anatomical mapping; Rotational angiography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Overall radiation exposure to the patient

  Pre-procedure (for CT cohort) to end of procedure

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael V Orlov, MD, PhD

  St. Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: February 23, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2014
• Last Updated: November 25, 2014

Record last verified: 2012-03

Locations

US (2)