Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)

Evaluation of the VISITAG SURPOINT™ Module With External Processing Unit (EPU) When Used With the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Catheter ablation with EPU

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • CHI St. Vincent
  • California
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
    • San Diego, California, United States, 92037
      • Scripps Health
    • Santa Maria, California, United States, 93454
      • Marian Regional Medical Center
    • Santa Monica, California, United States, 90404
      • St. John's Providence
  • Colorado
    • Denver, Colorado, United States, 80204
      • University of Colorado Denver
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare
    • Orlando, Florida, United States, 92803
      • Florida Hospital
    • Pensacola, Florida, United States, 32501
      • Baptist Hospital/Cardiology Consultants
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory St. Joseph's
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Community
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Springfield, Illinois, United States, 62769
      • Prairie Heart Institute
  • Kentucky
    • Kensington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Oschner LSU Health Shreveport
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Lovelace Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New York, New York, United States, 10016
      • NYU Langone
    • New York, New York, United States, 10065
      • New York Presbyterian
    • New York, New York, United States, 10467
      • Albert Einstein College Of Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Heart Institute
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St Vincent Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Health Heart and Vascular Hospital
    • Austin, Texas, United States, 78705
      • St. David's Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Health
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Tacoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VISITAG SURPOINT Module 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Participants With Unanticipated Adverse Device Effects (UADEs)	Number of participants with UADEs was reported.	Up to 12 months
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
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)
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)
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
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
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
Number of Participants Who Underwent Repeat Ablation Procedures	Number of participants who underwent repeat ablation procedures were reported.	Up to 12 months
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
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
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

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Publications and helpful links

General Publications

• Di Biase L, Monir G, Melby D, Tabereaux P, Natale A, Manyam H, Athill C, Delaughter C, Patel A, Gentlesk P, Liu C, Arkles J, McElderry HT Jr, Osorio J; SURPOINT Postapproval Trial Investigators. Composite Index Tagging for PVI in Paroxysmal AF: A Prospective, Multicenter Postapproval Study. JACC Clin Electrophysiol. 2022 Sep;8(9):1077-1089. doi: 10.1016/j.jacep.2022.06.007. Epub 2022 Aug 31.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BWI_2017_06

Drug and device information, study documents

• 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.: No