Clinical trial NCT01716663: CARTO® 3 System and Real Time Intracardiac Ultrasound
Official title: CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Paroxysmal AF
Keywords: Symptomatic paroxysmal
Atrial fibrillation
Observational
Acute procedural outcomes
Ablation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF

Brief summary: This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Detailed description: This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.

Eligibility criteria: Inclusion Criteria:

* Drug refractory, recurrent symptomatic paroxysmal AF
* Age 18 years or older
* Patients able and willing to provide written informed consent to participate in the study and comply with study requirements

Exclusion Criteria:

* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for atrial fibrillation
* AF episodes that last longer than 30 days
* Uncontrolled heart failure, or NYHA Class III or IV heart failure
* Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
* Contraindication to anticoagulation
* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
* Awaiting cardiac transplantation
* Heart disease for which corrective surgery is anticipated within 6 months
* Enrollment in other investigational drug or device study
* Subjects unwilling to comply with protocol or follow-up requirements
* Patients who are pregnant

Primary outcomes:
measure: Total Fluoroscopy Time
timeFrame: Day 0
Secondary outcomes:
measure: Total Procedure Time
timeFrame: Day 0
measure: Acute Procedural Success
timeFrame: Day 0
measure: Mean Number of Radiofrequency (RF) Applications
timeFrame: Day 0
measure: Total Radiofrequency (RF) Time
timeFrame: Day 0
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AZ Heart Rhythm Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Research Institute
state: Arizona
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Hospital
state: Florida
city: Gainsville
country: United States
facility: Northeast Georgia Heart Center, PC
state: Georgia
city: Joliet
country: United States
facility: Provena St. Joseph Medical Center
state: Illinois
city: Takoma Park
country: United States
facility: Washington Adventist Hospital CCVR
state: Maryland
city: Saginaw
country: United States
facility: Michigan CardioVascular Institute
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Newtown
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Heart Institute
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: San Antonio
country: United States
facility: Northeast Baptist Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Osceola Regional Medical Center
name: Usman Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mathew Hutchinson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scottsdale Healthcare Research
name: Andy Tran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.
name: Saumil Oza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JFK Medical Center
name: Robert Fishel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Heart Rhythm Research Center
name: Vijendra Swarup, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Adventist Hospital CCVR
name: Mohit Rastogi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Barbara Cottage Hospital
name: Brett Gidney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: John Scherschel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pepin Heart Hospital
name: Dilip Mathew, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: William Sauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Marcie Berger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kettering Medical Center
name: Khawaja Baig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tallahassee Research Institute
name: Farhat Khairallah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott & White Memorial Hospital
name: David Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Heart Institute
name: Gopi Dandamudi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Provena St. Joseph Medical Center
name: Ahmad Abdul-Karim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Main Line Health
name: Douglas Esberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mary's Medical Center
name: Scott Burke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellmont CVA Heart Institute
name: Gregory Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Tapan Rami, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeast Georgia Heart Center, PC
name: Salem Sayar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack Meridian Health
name: Gunjan Shukla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sentara Norfolk General Hospital
name: Philip Gentlesk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan CardioVascular Institute
name: Asim Yunus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeast Baptist Hospital
name: Scott Reich, MD
role: PRINCIPAL_INVESTIGATOR
References: