CompletedNCT01716663IUAFUpdated Dec 1, 2014Results posted

CARTO® 3 System and Real Time Intracardiac Ultrasound

An observational study in Atrial Fibrillation and Paroxysmal AF, sponsored by Biosense Webster, Inc.. Completed at 26 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-01.

Sponsored by Biosense Webster, Inc. · Observational

Study type: Observational
Time perspective: Prospective
Enrollment: 234
Ages: 18 Years and older
Sex: All

Study 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).

Read the 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.

Conditions studied

Atrial Fibrillation
Paroxysmal AF

Browse trials for

Atrial Fibrillation 3,870

Keywords

Symptomatic paroxysmal
Atrial fibrillation
Observational
Acute procedural outcomes
Ablation

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 234 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Biosense Webster, Inc. is the lead sponsor of 65 studies on the registry; 10 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF

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

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

Study design

Time perspective: Prospective
Enrollment: 234 participants (actual)

Groups and cohorts

Experimental: Catheter Ablation
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Device: Catheter Ablation

Interventions

DeviceCatheter Ablation
NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Also known as: CARTO® 3 System and Real Time Intracardiac Ultrasound

What researchers measure

Primary outcomes

Total Fluoroscopy Time
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
Time frame: Day 0

Secondary outcomes

Total Procedure Time
The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
Time frame: Day 0
Acute Procedural Success
Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.
Time frame: Day 0
Mean Number of Radiofrequency (RF) Applications
RF application is defined as the number of times RF energy is delivered during the procedure.
Time frame: Day 0
Total Radiofrequency (RF) Time
Total RF time is defined as the total time RF is delivered during the procedure.
Time frame: Day 0

Results

Posted Dec 1, 2014

Participant flow

Participant flow — Overall Study
Milestone	Experimental: Catheter Ablation
Started	234
Safety	230
Completed	228
Not completed	6
Withdrew: Withdrawn prior to procedure	4
Withdrew: Treated with non-study catheter	2

Outcome measures

PrimaryTotal Fluoroscopy Time

The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.

Time frame:: Day 0
Reported as:: Mean · minutes

Total Fluoroscopy Time
minutes	Experimental: Catheter Ablation
Total Fluoroscopy Time	28.3 ± 29.71

SecondaryTotal Procedure Time

The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.

Time frame:: Day 0
Reported as:: Mean · minutes

Total Procedure Time
minutes	Experimental: Catheter Ablation
Total Procedure Time	150.2 ± 76.32

SecondaryAcute Procedural Success

Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.

Time frame:: Day 0
Reported as:: Number · participants

Acute Procedural Success
participants	Experimental: Catheter Ablation
Acute Procedural Success	226

SecondaryMean Number of Radiofrequency (RF) Applications

RF application is defined as the number of times RF energy is delivered during the procedure.

Time frame:: Day 0
Reported as:: Mean · number of applications

Mean Number of Radiofrequency (RF) Applications
number of applications	Experimental: Catheter Ablation
Mean Number of Radiofrequency (RF) Applications	54.2 ± 43.95

SecondaryTotal Radiofrequency (RF) Time

Total RF time is defined as the total time RF is delivered during the procedure.

Time frame:: Day 0
Reported as:: Mean · minutes

Total Radiofrequency (RF) Time
minutes	Experimental: Catheter Ablation
Total Radiofrequency (RF) Time	104.7 ± 57.64

Adverse events

Collected over 7 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Experimental: Catheter Ablation	—	22/230 (9.6%)	13/230 (5.7%)

Most frequent serious events

Showing 10 of 18

Most frequent serious events
Event	Experimental: Catheter Ablation
pericardial effusion/tamponadeCardiac disorders	3/230
pericarditisCardiac disorders	3/230
cardiac failure congestiveCardiac disorders	2/230
vascular pseudoaneurysmInjury, poisoning and procedural complications	2/230
atrial fibrillationCardiac disorders	1/230
atrial flutterCardiac disorders	1/230
atrioventricular blockCardiac disorders	1/230
vertigo positionalEar and labyrinth disorders	1/230
chest painGeneral disorders	1/230
puncture site hemorrhageGeneral disorders	1/230

Most frequent other events

Most frequent other events
Event	Experimental: Catheter Ablation
atrial fibrillationCardiac disorders	7/230
pyrexiaGeneral disorders	4/230
pericarditisCardiac disorders	3/230

Baseline characteristics

Enrolled

Age, Categorical
Age, Categorical(Participants)	Experimental: Catheter Ablation
<=18 years	0
Between 18 and 65 years	120
>=65 years	114

Age, Continuous
Age, Continuous(years)	Experimental: Catheter Ablation
Mean	62.1 ± 11.6

Sex: Female, Male
Sex: Female, Male(Participants)	Experimental: Catheter Ablation
Female	94
Male	140

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Experimental: Catheter Ablation
Hispanic or Latino	4
Not Hispanic or Latino	230
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Experimental: Catheter Ablation
American Indian or Alaska Native	1
Asian	3
Native Hawaiian or Other Pacific Islander	0
Black or African American	4
White	223
More than one race	1
Unknown or Not Reported	2

Study locations

26 sites

AZ Heart Rhythm Research Center
Phoenix, Arizona 85013, United States
Scottsdale Healthcare Research Institute
Scottsdale, Arizona 85260, United States
Santa Barbara Cottage Hospital
Santa Barbara, California 93105, United States
University of Colorado Denver
Aurora, Colorado 80045, United States
JFK Medical Center
Atlantis, Florida 33462, United States
East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida 33204, United States
Osceola Regional Medical Center
Kissimmee, Florida 34741, United States
Tallahassee Research Institute
Tallahassee, Florida 32308, United States
Pepin Heart Hospital
Tampa, Florida 33613, United States
Northeast Georgia Heart Center, PC
Gainsville, Georgia 30501, United States
Provena St. Joseph Medical Center
Joliet, Illinois 60435, United States
Washington Adventist Hospital CCVR
Takoma Park, Maryland 20912, United States
Michigan CardioVascular Institute
Saginaw, Michigan 48601, United States
University of Nebraska Medical Center
Omaha, Nebraska 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey 07601, United States
Kettering Medical Center
Kettering, Ohio 45429, United States
St. Mary Medical Center
Newtown, Pennsylvania 18940, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Geisinger Heart Institute
Wilkes-Barre, Pennsylvania 18711, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania 19096, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee 37660, United States
The Methodist Hospital Research Institute
Houston, Texas 77030, United States
Northeast Baptist Hospital
San Antonio, Texas 78217, United States
Scott & White Memorial Hospital
Temple, Texas 76508, United States
Sentara Norfolk General Hospital
Norfolk, Virginia 23507, United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01716663
Lead sponsor: Biosense Webster, Inc.
Responsible party: Sponsor
First posted: Oct 30, 2012
Start date: Oct 2012
Primary completion: Sep 2013
Completion: Sep 2013
Results posted: Dec 1, 2014
Last update: Dec 1, 2014

Study contacts

Usman Siddiqui, MD

principal investigator · Osceola Regional Medical Center

Mathew Hutchinson, MD

principal investigator · University of Pennsylvania

Andy Tran, MD

principal investigator · Scottsdale Healthcare Research

Saumil Oza, MD

principal investigator · East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.

Robert Fishel, MD

principal investigator · JFK Medical Center

Vijendra Swarup, MD

principal investigator · AZ Heart Rhythm Research Center

Mohit Rastogi, MD

principal investigator · Washington Adventist Hospital CCVR

Brett Gidney, MD

principal investigator · Santa Barbara Cottage Hospital

John Scherschel, MD

principal investigator · University of Nebraska

Dilip Mathew, MD

principal investigator · Pepin Heart Hospital

William Sauer, MD

principal investigator · University of Colorado, Denver

Marcie Berger, MD

principal investigator · Medical College of Wisconsin

Khawaja Baig, MD

principal investigator · Kettering Medical Center

Farhat Khairallah, MD

principal investigator · Tallahassee Research Institute

David Fitzgerald, MD

principal investigator · Scott & White Memorial Hospital

Gopi Dandamudi, MD

principal investigator · Geisinger Heart Institute

Ahmad Abdul-Karim, MD

principal investigator · Provena St. Joseph Medical Center

Douglas Esberg, MD

principal investigator · Main Line Health

Scott Burke, MD

principal investigator · St. Mary's Medical Center

Gregory Jones, MD

principal investigator · Wellmont CVA Heart Institute

Tapan Rami, MD

principal investigator · The Methodist Hospital Research Institute

Salem Sayar, MD

principal investigator · Northeast Georgia Heart Center, PC

Gunjan Shukla, MD

principal investigator · Hackensack Meridian Health

Philip Gentlesk, MD

principal investigator · Sentara Norfolk General Hospital

Asim Yunus, MD

principal investigator · Michigan CardioVascular Institute

Scott Reich, MD

principal investigator · Northeast Baptist Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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