Atrial FibrillationIUAFNCT01716663
CARTO® 3 System and Real Time Intracardiac Ultrasound
An observational study of Atrial Fibrillation and Paroxysmal AF, run by Biosense Webster, Inc. at 26 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal AF
- What is being tested?
- Catheter Ablation
- Type of treatment
- Medical device
- How many people
- 234 participants
- Where
- 26 sitesUnited States
- Study dates
- Oct 2012to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
JFK Medical Center
Atlantis, Florida, 33462
University of Colorado Denver
Aurora, Colorado, 80045
Northeast Georgia Heart Center, PC
Gainsville, Georgia, 30501
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The Methodist Hospital Research Institute
Houston, Texas, 77030
East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida, 33204
Provena St. Joseph Medical Center
Joliet, Illinois, 60435
Kettering Medical Center
Kettering, Ohio, 45429
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
St. Mary Medical Center
Newtown, Pennsylvania, 18940
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
AZ Heart Rhythm Research Center
Phoenix, Arizona, 85013
Michigan CardioVascular Institute
Saginaw, Michigan, 48601
Northeast Baptist Hospital
San Antonio, Texas, 78217
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, 85260
Washington Adventist Hospital CCVR
Takoma Park, Maryland, 20912
Tallahassee Research Institute
Tallahassee, Florida, 32308
Pepin Heart Hospital
Tampa, Florida, 33613
Scott & White Memorial Hospital
Temple, Texas, 76508
Geisinger Heart Institute
Wilkes-Barre, Pennsylvania, 18711
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
About this study
Official title: CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study
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
- Atrial Fibrillation, Paroxysmal AF
- Being tested
- Catheter Ablation
- Keywords
- Symptomatic paroxysmal, Atrial fibrillation, Observational, Acute procedural outcomes, Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationDevice
Also called CARTO® 3 System and Real Time Intracardiac Ultrasound
NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
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.
Measured: 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.
Measured: Day 0
Mean Number of Radiofrequency (RF) Applications
RF application is defined as the number of times RF energy is delivered during the procedure.
Measured: Day 0
Total Radiofrequency (RF) Time
Total RF time is defined as the total time RF is delivered during the procedure.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Usman Siddiqui, MD, Principal investigator, Osceola Regional Medical CenterMathew Hutchinson, MD, Principal investigator, University of PennsylvaniaAndy Tran, MD, Principal investigator, Scottsdale Healthcare ResearchSaumil Oza, MD, Principal investigator, East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.Robert Fishel, MD, Principal investigator, JFK Medical CenterVijendra Swarup, MD, Principal investigator, AZ Heart Rhythm Research CenterMohit Rastogi, MD, Principal investigator, Washington Adventist Hospital CCVRBrett Gidney, MD, Principal investigator, Santa Barbara Cottage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716663
- Sponsor's protocol ID
- IUAF
- Acronym
- IUAF
- Status last verified
- Nov 2014
- First submitted
- 19 Oct 2012
- Last updated
- 1 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study
- ClinicalTrials.gov ID
- NCT01716663
- Acronym / sponsor ID
- IUAF / IUAF
- Conditions
- Atrial Fibrillation, Paroxysmal AF
- Keywords
- Symptomatic paroxysmal, Atrial fibrillation, Observational, Acute procedural outcomes, Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 1 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Catheter Ablation | – | Device: Catheter AblationThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter AblationAlso: CARTO® 3 System and Real Time Intracardiac UltrasoundNAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module) | Device | Experimental: Catheter Ablation |
Primary outcome
Total Fluoroscopy Time
Time frame: 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.
4 secondary outcomes
Total Procedure Time
Time frame: Day 0
Acute Procedural Success
Time frame: Day 0
Mean Number of Radiofrequency (RF) Applications
Time frame: Day 0
Total Radiofrequency (RF) Time
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Paroxysmal AF, run by Biosense Webster, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Fluoroscopy Time (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2014.