CARTO® 3 System and Real Time Intracardiac Ultrasound

CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01716663

Acronym

IUAF

Enrollment

234

Registered

2012-10-30

Start date

2012-10-31

Completion date

2013-09-30

Last updated

2014-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Paroxysmal AF

Keywords

Symptomatic paroxysmal, Atrial fibrillation, Observational, Acute procedural outcomes, Ablation

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.

Interventions

DEVICECatheter Ablation

NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
Mean Number of Radiofrequency (RF) Applications	Day 0	RF application is defined as the number of times RF energy is delivered during the procedure.
Total Radiofrequency (RF) Time	Day 0	Total RF time is defined as the total time RF is delivered during the procedure.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)	234
Total	234

Arm

Count

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. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

234

Total

234

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Treated with non-study catheter	2
Overall Study	Withdrawn prior to procedure	4

Baseline characteristics

Characteristic	Experimental: Catheter Ablation
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	114 Participants
Age, Categorical Between 18 and 65 years	120 Participants
Age, Continuous	62.1 years STANDARD_DEVIATION 11.6
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	230 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	3 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) White	223 Participants
Sex: Female, Male Female	94 Participants
Sex: Female, Male Male	140 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	13 / 230
serious Total, serious adverse events	22 / 230

Arm	Measure	Value (MEAN)	Dispersion
Experimental: Catheter Ablation	Total Radiofrequency (RF) Time	104.7 minutes	Standard Deviation 57.64

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026