Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03624881
Other study ID # BWI_2017_06
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 4, 2018
Est. completion date June 28, 2021

Study information

Verified date June 2023
Source Biosense Webster, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit.


Description:

Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit. The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of Tag Index-guided ablation using the VISITAG SURPOINT™ Module with External Processing Unit when used with the THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheters for pulmonary vein isolation (PVI) in the treatment of subjects with drug refractory symptomatic paroxysmal atrial fibrillation. Specifically: - To demonstrate the safety based on the proportion of subjects with early-onset (within 7 days of ablation procedure) primary adverse events - To demonstrate the 12-month effectiveness based on the proportion of subject with freedom from documented atrial arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) episodes during the effectiveness evaluation period (Day 91-365)


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date June 28, 2021
Est. primary completion date June 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Symptomatic paroxysmal AF who had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip 2. Failed at least one antiarrhythmic drug (AAD) (Class I or III antiarrhythmic drugs) as evidenced by recurrent symptomatic AF, or intolerable to the AAD 3. Age 18 years or older 4. Signed Patient Informed Consent Form (ICF) 5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: Subjects who meet any of the following exclusion criteria are not eligible for enrollment. 1. Previous surgical or catheter ablation for atrial fibrillation 2. Previous cardiac surgery (including CABG) within the past 6 months (180 days) 3. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) 4. Any carotid stenting or endarterectomy 5. Documented LA thrombus on imaging 6. LA size > 50 mm (parasternal long axis view) 7. LVEF < 40% 8. Contraindication to anticoagulation (heparin or warfarin) 9. History of blood clotting or bleeding abnormalities 10. PCI/MI within the past 2 months (60 days) 11. Documented thromboembolic event (including TIA) within the past 12 months (365 days) 12. Rheumatic Heart Disease 13. Uncontrolled heart failure or NYHA function class III or IV 14. Severe mitral regurgitation (Regurgitant volume = 60 mL/beat, Regurgitant fraction = 50%, and/or Effective regurgitant orifice area = 0.40cm2) 15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 16. Unstable angina 17. Acute illness or active systemic infection or sepsis 18. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 19. Presence of implanted ICD/CRT-D. 20. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms. 21. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including OTC medication) 22. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. 23. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 24. Concurrent enrollment in an investigational study evaluating another device, biologic, or drug. 25. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes vascular access, or manipulation of the catheter. 26. Life expectancy less than 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Catheter ablation with EPU
Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation

Locations

Country Name City State
United States Albany Medical Center Albany New York
United States Lovelace Medical Center Albuquerque New Mexico
United States University of Michigan Ann Arbor Michigan
United States Texas Health Heart and Vascular Hospital Arlington Texas
United States Emory St. Joseph's Atlanta Georgia
United States JFK Medical Center Atlantis Florida
United States St. David's Medical Center Austin Texas
United States Grandview Medical Center Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
United States Medical University of South Carolina Charleston South Carolina
United States Erlanger Health System Chattanooga Tennessee
United States Cleveland Clinic Cleveland Ohio
United States Ohio State University Medical Center Columbus Ohio
United States University of Colorado Denver Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States Evanston Community Evanston Illinois
United States Greenville Health System Greenville South Carolina
United States Memorial Healthcare Hollywood Florida
United States Huntsville Hospital Huntsville Alabama
United States Baptist Health Lexington Kensington Kentucky
United States CHI St. Vincent Little Rock Arkansas
United States Loyola University Medical Center Maywood Illinois
United States Abbott Northwestern Minneapolis Minnesota
United States Intermountain Medical Murray Utah
United States Albert Einstein College of Medicine New York New York
United States New York Presbyterian New York New York
United States NYU Langone New York New York
United States Sentara Health Norfolk Virginia
United States Oklahoma Heart Institute Oklahoma City Oklahoma
United States Florida Hospital Orlando Florida
United States Baptist Hospital/Cardiology Consultants Pensacola Florida
United States University of Pennsylvania Philadelphia Pennsylvania
United States Providence St Vincent Medical Center Portland Oregon
United States San Diego Cardiac Center San Diego California
United States Scripps Health San Diego California
United States Marian Regional Medical Center Santa Maria California
United States St. John's Providence Santa Monica California
United States Oschner LSU Health Shreveport Shreveport Louisiana
United States Prairie Heart Institute Springfield Illinois
United States MultiCare Tacoma Tacoma Washington
United States Tampa General Hospital Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Primary Adverse Events (PAEs) A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Up to 12 months
Primary Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic) Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation [AF], atrial flutter [AFL], and atrial tachycardia [AT]) were reported. Up to 12 months
Secondary Percentage of Participants With Cumulative PAEs A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Up to 12 months
Secondary Number of Participants With Unanticipated Adverse Device Effects (UADEs) Number of participants with UADEs was reported. Up to 12 months
Secondary Number of Participants With Serious Non-Primary AEs Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Up to 12 months
Secondary Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (>=) 2 grams per deciliter (g/dL), transfusion of >= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events. Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months)
Secondary Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported. End of the Procedure (up to 12 months)
Secondary Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported. Up to 12 months
Secondary Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported. Up to 12 months
Secondary Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). Up to 12 months
Secondary Number of Participants Who Underwent Repeat Ablation Procedures Number of participants who underwent repeat ablation procedures were reported. Up to 12 months
Secondary Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported. Up to 12 months
Secondary Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure was reported. Up to 12 months
Secondary Percentage of Participants With 12-Month Single Procedure Success Percentage of participants with 12-month single procedure success was reported. It is defined as freedom from 1) any repeat procedure for Atrial fibrillation (AF)/Atrial tachycardia (AT)/Atrial flutter (AFL) post index procedure; 2) any class I/III AAD taking during the evaluation period; 3) documented AF/AT/AFL recurrence in evaluation period. Up to 12 months
See also
  Status Clinical Trial Phase
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Recruiting NCT05905835 - Treatment of PAF With the Synaptic System N/A
Active, not recruiting NCT05618340 - PFA for Paroxysmal Atrial Fibrillation N/A
Active, not recruiting NCT05534581 - SINGLE SHOT CHAMPION Phase 4
Not yet recruiting NCT05024630 - Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension N/A
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Completed NCT01913522 - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration N/A
Withdrawn NCT01917981 - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation Phase 3
Terminated NCT01925885 - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) N/A
Completed NCT01693107 - Atrial Fibrillation Force Contact Ablation Study
Completed NCT01842529 - Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery Phase 2
Completed NCT00971204 - Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation Phase 2
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Recruiting NCT05172765 - Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF) N/A
Recruiting NCT04529785 - Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific
Completed NCT00964392 - NAVISTAR® THERMOCOOL® Catheter Post Approval Registry Phase 4
Recruiting NCT03912324 - Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II) N/A