CARTO® 3 System and Real Time Intracardiac Ultrasound
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/1/2014 |
Start Date: | October 2012 |
End Date: | October 2013 |
Contact: | Timothy Hentges |
Email: | thentges@its.jnj.com |
Phone: | 623-326-4343 |
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).
years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal
Atrial Fibrillation (AF).
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.
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.
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
We found this trial at
19
sites
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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