Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation

NCT01036724 | Terminated Results

• 1 other identifier: BWICO1
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation with either the CARTO® 3 or the NavX(TM) System. It is hypothesized that described features will reduce the median radiation exposure during the CARTO® 3 system-guided procedures compared to the NavX(TM) system-guided procedures.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Total Fluoroscopy Time

  The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures.

  Throughout the Total Duration of the Procedure

Secondary Outcomes (1)

• Total Procedure Time

  Total Duration of the Procedure

Study Arms (2)

Carto 3

Those subjects whose cases use the CARTO 3 EP Navigation System.

Device: Cardiac Mapping

NAVX

Those subjects whose cases use the NAVX(TM) EP Navigational System.

Device: Cardiac Mapping

Interventions

Cardiac Mapping DEVICE

Generating a cardiac map using the study device (CARTO 3) compared to the control device (NAVX\[TM\]) and measuring the amount of radiation exposure duration for each.

Carto 3; NAVX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects referred for Radiofrequency ablation treatment for paroxysmal atrial fibrillation.

You may qualify if:

• All patients referred for a first radiofrequency ablation procedure for treatment of paroxysmal atrial fibrillation (AF episodes that last less than 30 days and are not terminated via cardioversion) and who are considered eligible for treatment by the physician.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (6)

Vancouver Island Health Authority - Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

QE II Health Sciences Center

Halifax, Nova Scotia, B3H 3Q7, Canada

Location

London Health Sciences

London, Ontario, N6A 5A5, Canada

Location

Southlake Regional Healthcare Centre

Newmarket, Ontario, L3Y8C3, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Laval Hopital

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated early, with 107 enrolled and 93 evaluable subjects, due to difficulty enrolling despite prolonged extension of the enrollment period. The original design called for 176 enrolled and 122 evaluable patients.

Results Point of Contact

• Title: Dr. Tina Hunter, Consulting Statistician to Biosense Webster
• Organization: CTI Clinical Trials and Consulting

tinah@s2stats.com

513-619-5541

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 25, 2010
• Last Updated: September 27, 2017
• Results First Posted: July 21, 2014

Record last verified: 2017-08

Locations

CA (6)