Back to resultsA Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Primary Purpose
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NUVISION NAV Ultrasound Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Scar-related Atrial Tachycardia
Eligibility Criteria
Inclusion Criteria: Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included) Signed participants Informed Consent Form (ICF) Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: Structural heart defect which can only be repaired by cardiac surgery Pericarditis within 6 months Left ventricular ejection fraction (LVEF) less than or equal to (<=) 25 percent (%) for ventricular tachycardia (VT) participants LVEF <= 40% for participants with atrial arrhythmia History of chronic gastro-intestinal medical problems involving the esophagus, stomach and/or untreated acid reflux History of abnormal bleeding and/or clotting disorder Clinically significant infection or sepsis History of stroke or transient ischemic attack (TIA) within the past 6 months of enrollment Uncontrolled heart failure or New York Heart Association (NYHA) function class IV Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days) Implanted with a mechanical valve Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation Any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism, or significant coagulation disorder) Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being Concurrent enrollment in an investigational study evaluating another device or drug
Sites / Locations
- KBC SplitRecruiting
- Sourasky (Ichilov) Medical Center
- Yitzhak Shamir Medical Center
- Centro Cardiologico Monzino
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NUVISION NAV Ultrasound Catheter
Arm Description
Participants with five different subgroups (scar-related atrial tachycardia, persistent atrial fibrillation [PsAF], paroxysmal atrial fibrillation [PVF], ventricular tachycardia [VT], and premature ventricular complex [PVC]) will be treated using NUVISION NAV ultrasound catheter per investigator's standard of care and followed until 7 days post-procedure.
Outcomes
Primary Outcome Measures
Number of Participants with Completion of Imaging with the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
Number of participants who have successfully completed the procedure (imaging with the NUVISION NAV ultrasound catheter) without resort to a non-study ultrasound device will be reported.
Number of Participants with Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
Secondary Outcome Measures
Physician Assessment of Deployment, Maneuverability, Navigational Features and Imaging Quality Acquired with the NUVISION NAV Ultrasound Catheter During the Study Procedures
Physician assessment on deployment, maneuverability, navigational features, and imaging quality acquired with the NUVISION NAV ultrasound catheter will be reported. A post-procedure survey will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.
Number of Participants with Other SAEs (Excluding NUVISION NAV Ultrasound Catheter Related SAE) Within 7 Days of Index Procedure
Number of Participants with other SAEs (excluding NUVISION NAV ultrasound catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
Number of Participants with Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. An adverse event is any untoward medical occurrence in a participant whether or not related to the investigational device.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05970120
Brief Title
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Official Title
Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
December 24, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the performance and safety of using the investigational catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia, Premature Ventricular Complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NUVISION NAV Ultrasound Catheter
Arm Type
Experimental
Arm Description
Participants with five different subgroups (scar-related atrial tachycardia, persistent atrial fibrillation [PsAF], paroxysmal atrial fibrillation [PVF], ventricular tachycardia [VT], and premature ventricular complex [PVC]) will be treated using NUVISION NAV ultrasound catheter per investigator's standard of care and followed until 7 days post-procedure.
Intervention Type
Device
Intervention Name(s)
NUVISION NAV Ultrasound Catheter
Intervention Description
Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
Primary Outcome Measure Information:
Title
Number of Participants with Completion of Imaging with the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
Description
Number of participants who have successfully completed the procedure (imaging with the NUVISION NAV ultrasound catheter) without resort to a non-study ultrasound device will be reported.
Time Frame
Up to 5 months
Title
Number of Participants with Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Description
Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
Time Frame
Up to 7 days of index procedure
Secondary Outcome Measure Information:
Title
Physician Assessment of Deployment, Maneuverability, Navigational Features and Imaging Quality Acquired with the NUVISION NAV Ultrasound Catheter During the Study Procedures
Description
Physician assessment on deployment, maneuverability, navigational features, and imaging quality acquired with the NUVISION NAV ultrasound catheter will be reported. A post-procedure survey will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.
Time Frame
Up to 5 months
Title
Number of Participants with Other SAEs (Excluding NUVISION NAV Ultrasound Catheter Related SAE) Within 7 Days of Index Procedure
Description
Number of Participants with other SAEs (excluding NUVISION NAV ultrasound catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
Time Frame
Up to 7 days of index procedure
Title
Number of Participants with Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Description
Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. An adverse event is any untoward medical occurrence in a participant whether or not related to the investigational device.
Time Frame
Up to 7 days of index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)
Signed participants Informed Consent Form (ICF)
Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
Structural heart defect which can only be repaired by cardiac surgery
Pericarditis within 6 months
Left ventricular ejection fraction (LVEF) less than or equal to (<=) 25 percent (%) for ventricular tachycardia (VT) participants
LVEF <= 40% for participants with atrial arrhythmia
History of chronic gastro-intestinal medical problems involving the esophagus, stomach and/or untreated acid reflux
History of abnormal bleeding and/or clotting disorder
Clinically significant infection or sepsis
History of stroke or transient ischemic attack (TIA) within the past 6 months of enrollment
Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
Implanted with a mechanical valve
Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
Any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention
Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism, or significant coagulation disorder)
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
Concurrent enrollment in an investigational study evaluating another device or drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
+32 479 97 05 05
Email
nmacours1@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biosense Webster, Inc Clinical Trial
Organizational Affiliation
Biosense Webster, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
KBC Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Sourasky (Ichilov) Medical Center
City
Tel Aviv-Yafo
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Yitzhak Shamir Medical Center
City
Zerifin
ZIP/Postal Code
7033001
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
IPD Sharing URL
http://yoda.yale.edu
Citations:
PubMed Identifier
19647156
Citation
Perk G, Lang RM, Garcia-Fernandez MA, Lodato J, Sugeng L, Lopez J, Knight BP, Messika-Zeitoun D, Shah S, Slater J, Brochet E, Varkey M, Hijazi Z, Marino N, Ruiz C, Kronzon I. Use of real time three-dimensional transesophageal echocardiography in intracardiac catheter based interventions. J Am Soc Echocardiogr. 2009 Aug;22(8):865-82. doi: 10.1016/j.echo.2009.04.031.
Results Reference
background
PubMed Identifier
24651102
Citation
Faletra FF, Pedrazzini G, Pasotti E, Muzzarelli S, Dequarti MC, Murzilli R, Schlossbauer SA, Slater IP, Moccetti T. 3D TEE during catheter-based interventions. JACC Cardiovasc Imaging. 2014 Mar;7(3):292-308. doi: 10.1016/j.jcmg.2013.10.012.
Results Reference
background
PubMed Identifier
25034183
Citation
Anter E, Silverstein J, Tschabrunn CM, Shvilkin A, Haffajee CI, Zimetbaum PJ, Buxton AE, Josephson ME, Gelfand E, Manning WJ. Comparison of intracardiac echocardiography and transesophageal echocardiography for imaging of the right and left atrial appendages. Heart Rhythm. 2014 Nov;11(11):1890-7. doi: 10.1016/j.hrthm.2014.07.015. Epub 2014 Jul 14.
Results Reference
background
PubMed Identifier
24898198
Citation
Rigatelli G, Dell'Avvocata F, Giordan M, Viceconte N, Osanna RA, Braggion G, Aggio S, Cardaioli P, Chen JP. Usefulness of intracardiac echocardiography with a mechanical probe for catheter-based interventions: a 10-year prospective registry. J Clin Ultrasound. 2014 Nov-Dec;42(9):534-43. doi: 10.1002/jcu.22177. Epub 2014 Jun 4.
Results Reference
background
PubMed Identifier
24998516
Citation
Medford BA, Taggart NW, Cabalka AK, Cetta F, Reeder GS, Hagler DJ, Johnson JN. Intracardiac echocardiography during atrial septal defect and patent foramen ovale device closure in pediatric and adolescent patients. J Am Soc Echocardiogr. 2014 Sep;27(9):984-90. doi: 10.1016/j.echo.2014.05.017. Epub 2014 Jul 4.
Results Reference
background
PubMed Identifier
20473373
Citation
Kabra R, Singh J. Recent trends in imaging for atrial fibrillation ablation. Indian Pacing Electrophysiol J. 2010 May 5;10(5):215-27.
Results Reference
background
PubMed Identifier
21768032
Citation
Lee W, Griffin W, Wildes D, Buckley D, Topka T, Chodakauskas T, Langer M, Calisti S, Bergstol S, Malacrida JP, Lanteri F, Maffre J, McDaniel B, Shivkumar K, Cummings J, Callans D, Silvestry F, Packer D. A 10-Fr ultrasound catheter with integrated micromotor for 4-D intracardiac echocardiography. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Jul;58(7):1478-91. doi: 10.1109/TUFFC.2011.1967.
Results Reference
background
PubMed Identifier
24930123
Citation
Silvestry FE, Kadakia MB, Willhide J, Herrmann HC. Initial experience with a novel real-time three-dimensional intracardiac ultrasound system to guide percutaneous cardiac structural interventions: a phase 1 feasibility study of volume intracardiac echocardiography in the assessment of patients with structural heart disease undergoing percutaneous transcatheter therapy. J Am Soc Echocardiogr. 2014 Sep;27(9):978-83. doi: 10.1016/j.echo.2014.04.022. Epub 2014 Jun 11.
Results Reference
background
PubMed Identifier
32327072
Citation
Alkhouli M, Chaker Z, Alqahtani F, Raslan S, Raybuck B. Outcomes of Routine Intracardiac Echocardiography to Guide Left Atrial Appendage Occlusion. JACC Clin Electrophysiol. 2020 Apr;6(4):393-400. doi: 10.1016/j.jacep.2019.11.014. Epub 2020 Jan 29.
Results Reference
background
PubMed Identifier
35926926
Citation
Flautt T, Da-Wariboko A, Lador A, Patel A, Guevara M, Valderrabano M. Left Atrial Appendage Occlusion Without Fluoroscopy: Optimization by 4D Intracardiac Echocardiography. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1592-1594. doi: 10.1016/j.jcin.2022.05.008. No abstract available.
Results Reference
background
PubMed Identifier
19497437
Citation
Kim SS, Hijazi ZM, Lang RM, Knight BP. The use of intracardiac echocardiography and other intracardiac imaging tools to guide noncoronary cardiac interventions. J Am Coll Cardiol. 2009 Jun 9;53(23):2117-28. doi: 10.1016/j.jacc.2009.01.071.
Results Reference
background
PubMed Identifier
24144789
Citation
Bartel T, Muller S, Biviano A, Hahn RT. Why is intracardiac echocardiography helpful? Benefits, costs, and how to learn. Eur Heart J. 2014 Jan;35(2):69-76. doi: 10.1093/eurheartj/eht411. Epub 2013 Oct 21.
Results Reference
background
PubMed Identifier
33990269
Citation
Gianni C, Sanchez JE, Della Rocca DG, Al-Ahmad A, Horton RP, Di Biase L, Natale A. Intracardiac Echocardiography to Guide Catheter Ablation of Atrial Fibrillation. Card Electrophysiol Clin. 2021 Jun;13(2):303-311. doi: 10.1016/j.ccep.2021.03.009. Epub 2021 Apr 23.
Results Reference
background
Citation
D. Fornell, "First-in-Human Experience With Novel 4D ICE Catheter For Catheter Ablation and LAA Closure Procedures," 05 Aug 2021. [Online]. Available: https://www.dicardiology.com/content/first-human-experience-novel-4d-ice-catheter-catheter-ablation-and-laa-closure-procedures. [Accessed 18 Oct 2022].
Results Reference
background
PubMed Identifier
29021841
Citation
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. J Arrhythm. 2017 Oct;33(5):369-409. doi: 10.1016/j.joa.2017.08.001. Epub 2017 Sep 15. No abstract available.
Results Reference
background
PubMed Identifier
10726030
Citation
Bick RL, Frenkel EP. Clinical aspects of heparin-induced thrombocytopenia and thrombosis and other side effects of heparin therapy. Clin Appl Thromb Hemost. 1999 Oct;5 Suppl 1:S7-15. doi: 10.1177/10760296990050s103.
Results Reference
background
PubMed Identifier
12751552
Citation
Cox B, Durieux ME, Marcus MA. Toxicity of local anaesthetics. Best Pract Res Clin Anaesthesiol. 2003 Mar;17(1):111-36. doi: 10.1053/bean.2003.0275.
Results Reference
background
PubMed Identifier
12592301
Citation
Gruchalla RS. 10. Drug allergy. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S548-59. doi: 10.1067/mai.2003.93.
Results Reference
background
PubMed Identifier
12074414
Citation
Mertes PM, Laxenaire MC. Allergic reactions occurring during anaesthesia. Eur J Anaesthesiol. 2002 Apr;19(4):240-62. doi: 10.1017/s0265021502000418.
Results Reference
background
PubMed Identifier
11511894
Citation
Morcos SK, Thomsen HS, Webb JA; Contrast Media Safety Committee of the European Society of Urogenital Radiology. Prevention of generalized reactions to contrast media: a consensus report and guidelines. Eur Radiol. 2001;11(9):1720-8. doi: 10.1007/s003300000778.
Results Reference
background
Citation
A. C. Lin and D. J. Wilber, Complications Associated With Radiofrequency Catheter Ablation, in Radiofrequency catheter ablation of cardiac arrhythmias: basic concepts and clinical applications, S. H. a. D. Wilber, Ed., Armonk, N.Y.: Futura Publishing Co. Inc., 2000, pp. 737-746
Results Reference
background
PubMed Identifier
10879389
Citation
Scheinman MM, Huang S. The 1998 NASPE prospective catheter ablation registry. Pacing Clin Electrophysiol. 2000 Jun;23(6):1020-8. doi: 10.1111/j.1540-8159.2000.tb00891.x.
Results Reference
background
PubMed Identifier
33476457
Citation
Mar PL, Chong L, Perez A, Lakkireddy D, Gopinathannair R. Entrapment of diagnostic catheter within Advisor HD grid mapping catheter. J Cardiovasc Electrophysiol. 2021 Mar;32(3):860-861. doi: 10.1111/jce.14893. Epub 2021 Jan 28.
Results Reference
background
PubMed Identifier
19995881
Citation
Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.
Results Reference
background
PubMed Identifier
11513440
Citation
Gerstenfeld EP, Guerra P, Sparks PB, Hattori K, Lesh MD. Clinical outcome after radiofrequency catheter ablation of focal atrial fibrillation triggers. J Cardiovasc Electrophysiol. 2001 Aug;12(8):900-8. doi: 10.1046/j.1540-8167.2001.00900.x.
Results Reference
background
PubMed Identifier
9769307
Citation
Kovoor P, Ricciardello M, Collins L, Uther JB, Ross DL. Risk to patients from radiation associated with radiofrequency ablation for supraventricular tachycardia. Circulation. 1998 Oct 13;98(15):1534-40. doi: 10.1161/01.cir.98.15.1534.
Results Reference
background
PubMed Identifier
7611155
Citation
Nahass GT. Fluoroscopy and the skin: implications for radiofrequency catheter ablation. Am J Cardiol. 1995 Jul 15;76(3):174-6. doi: 10.1016/s0002-9149(99)80053-8. No abstract available.
Results Reference
background
PubMed Identifier
1959193
Citation
Calkins H, Niklason L, Sousa J, el-Atassi R, Langberg J, Morady F. Radiation exposure during radiofrequency catheter ablation of accessory atrioventricular connections. Circulation. 1991 Dec;84(6):2376-82. doi: 10.1161/01.cir.84.6.2376.
Results Reference
background
Learn more about this trial
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
We'll reach out to this number within 24 hrs