IUAF: CARTO® 3 System and Real Time Intracardiac Ultrasound

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01716663
• Collaborator: (none)
• Enrollment: 234
• Locations: 26
• Duration (Months): 11
• Patients Per Site: 9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Paroxysmal AF	Device: Catheter Ablation

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 234 participants
• Time Perspective: Prospective
• Official Title: CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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; NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module); Other Names: CARTO® 3 System and Real Time Intracardiac Ultrasound

Outcome Measures

Primary Outcome Measures

1. Total Fluoroscopy Time [Day 0]

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

Secondary Outcome Measures

1. Total Procedure Time [Day 0]

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

2. Acute Procedural Success [Day 0]

   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.

3. Mean Number of Radiofrequency (RF) Applications [Day 0]

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

4. Total Radiofrequency (RF) Time [Day 0]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

• Principal Investigator: Usman Siddiqui, MD, Osceola Regional Medical Center
• Principal Investigator: Mathew Hutchinson, MD, University of Pennsylvania
• Principal Investigator: Andy Tran, MD, Scottsdale Healthcare Research
• Principal Investigator: Saumil Oza, MD, East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.
• Principal Investigator: Robert Fishel, MD, JFK Medical Center
• Principal Investigator: Vijendra Swarup, MD, AZ Heart Rhythm Research Center
• Principal Investigator: Mohit Rastogi, MD, Washington Adventist Hospital CCVR
• Principal Investigator: Brett Gidney, MD, Santa Barbara Cottage Hospital
• Principal Investigator: John Scherschel, MD, University of Nebraska
• Principal Investigator: Dilip Mathew, MD, Pepin Heart Hospital
• Principal Investigator: William Sauer, MD, University of Colorado, Denver
• Principal Investigator: Marcie Berger, MD, Medical College of Wisconsin
• Principal Investigator: Khawaja Baig, MD, Kettering Medical Center
• Principal Investigator: Farhat Khairallah, MD, Tallahassee Research Institute
• Principal Investigator: David Fitzgerald, MD, Scott & White Memorial Hospital
• Principal Investigator: Gopi Dandamudi, MD, Geisinger Heart Institute
• Principal Investigator: Ahmad Abdul-Karim, MD, Provena St. Joseph Medical Center
• Principal Investigator: Douglas Esberg, MD, Main Line Health
• Principal Investigator: Scott Burke, MD, St. Mary Medical Center
• Principal Investigator: Gregory Jones, MD, Wellmont CVA Heart Institute
• Principal Investigator: Tapan Rami, MD, The Methodist Hospital Research Institute
• Principal Investigator: Salem Sayar, MD, Northeast Georgia Heart Center, PC
• Principal Investigator: Gunjan Shukla, MD, Hackensack Meridian Health
• Principal Investigator: Philip Gentlesk, MD, Sentara Norfolk General Hospital
• Principal Investigator: Asim Yunus, MD, Michigan CardioVascular Institute
• Principal Investigator: Scott Reich, MD, Northeast Baptist Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT01716663
• Other Study ID Numbers: IUAF
• First Posted: Oct 30, 2012
• Last Update Posted: Dec 1, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Biosense Webster, Inc.: Symptomatic paroxysmal; Atrial fibrillation; Observational; Acute procedural outcomes; Ablation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Period Title: Overall Study
STARTED	234
Safety	230
COMPLETED	228
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Overall Participants	234
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	120 51.3%
>=65 years	114 48.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.1 (11.6)
Sex: Female, Male (Count of Participants)
Female	94 40.2%
Male	140 59.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 1.7%
Not Hispanic or Latino	230 98.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%
Asian	3 1.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 1.7%
White	223 95.3%
More than one race	1 0.4%
Unknown or Not Reported	2 0.9%

Outcome Measures

1. Primary Outcome

Title	Total Fluoroscopy Time
Description	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

Outcome Measure Data

Analysis Population Description

Those patients with non-missing fluoroscopy time.

Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Measure Participants	221
Mean (Standard Deviation) [minutes]	28.3 (29.71)

2. Secondary Outcome

Title	Total Procedure Time
Description	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

Outcome Measure Data

Analysis Population Description

The number of patients with non-missing procedure time data.

Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Measure Participants	225
Mean (Standard Deviation) [minutes]	150.2 (76.32)

3. Secondary Outcome

Title	Acute Procedural Success
Description	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

Outcome Measure Data

Analysis Population Description

Acute effectiveness and efficiency cohort

Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Measure Participants	228
Number [participants]	226 96.6%

4. Secondary Outcome

Title	Mean Number of Radiofrequency (RF) Applications
Description	RF application is defined as the number of times RF energy is delivered during the procedure.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Patients with non-missing RF application values

Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Measure Participants	227
Mean (Standard Deviation) [number of applications]	54.2 (43.95)

5. Secondary Outcome

Title	Total Radiofrequency (RF) Time
Description	Total RF time is defined as the total time RF is delivered during the procedure.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Patients with non-missing RF application time.

Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Measure Participants	227
Mean (Standard Deviation) [minutes]	104.7 (57.64)

Adverse Events

Time Frame	7 days
Arm/Group Title	Experimental: Catheter Ablation
Arm/Group Description	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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
All Cause Mortality
	Experimental: Catheter Ablation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Experimental: Catheter Ablation
	Affected / at Risk (%)	# Events
Total	22/230 (9.6%)
Cardiac disorders
atrial fibrillation	1/230 (0.4%)
atrial flutter	1/230 (0.4%)
atrioventricular block	1/230 (0.4%)
cardiac failure congestive	2/230 (0.9%)
pericardial effusion/tamponade	3/230 (1.3%)
pericarditis	3/230 (1.3%)
Ear and labyrinth disorders
vertigo positional	1/230 (0.4%)
General disorders
chest pain	1/230 (0.4%)
puncture site hemorrhage	1/230 (0.4%)
Infections and infestations
pneumonia	1/230 (0.4%)
Injury, poisoning and procedural complications
post procedural hematoma	1/230 (0.4%)
vascular pseudoaneurysm	2/230 (0.9%)
Investigations
cardiac telemetry abnormal	1/230 (0.4%)
Metabolism and nutrition disorders
fluid overload	1/230 (0.4%)
Nervous system disorders
migraine	1/230 (0.4%)
Respiratory, thoracic and mediastinal disorders
bronchospasm	1/230 (0.4%)
hypoxia	1/230 (0.4%)
pulmonary edema	1/230 (0.4%)
Other (Not Including Serious) Adverse Events
	Experimental: Catheter Ablation
	Affected / at Risk (%)	# Events
Total	13/230 (5.7%)
Cardiac disorders
atrial fibrillation	7/230 (3%)
pericarditis	3/230 (1.3%)
General disorders
pyrexia	4/230 (1.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present, or publish trial results after the trial is completed. Please contact Biosense Webster for additional information.