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

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ClinicalTrials.gov Identifier: NCT03624881
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: Catheter ablation with EPU Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Acute Safety- Incidence of early onset primary adverse events (PAE) [ Time Frame: 12 months ]

    The primary safety endpoint is the incidence of any primary adverse event occurring within 7 days following an AF ablation procedure (including the initial and repeat procedures) using the STSF/ST catheter with the EPU per protocol, except atrio-esophageal fistula and PV stenosis, which may also be considered as primary adverse events if occurring greater than seven (7) days post the ablation procedure.

    Primary adverse events include the following conditions:

    • Death
    • Atrio-esophageal fistula
    • Cardiac Tamponade*+/Perforation+
    • Myocardial infarction (MI)
    • Stroke / Cerebrovascular accident (CVA) †, ††
    • Thromboembolism
    • Transient Ischemic Attack
    • Diaphragmatic paralysis
    • Pneumothorax
    • Heart block
    • PV stenosis
    • Pulmonary edema (Respiratory Insuffciency)
    • Vagal Nerve Injury
    • Pericarditis
    • Major vascular access complication / bleeding

  2. 12 month effectiveness- Freedom from documented (Symptomatic and asymptomatic) atrial tachyarrhythmias" [ Time Frame: 12 month ]
    Freedom from documented (Symptomatic and asymptomatic) atrial fibrillation, atrial flutter and atrial tachycardia (AF/AFL/AT) (hereinafter collectively referred to as "atrial tachyarrhythmias") recurrence (episodes ≥ 30 secs on TTM or continuously recorded on the standard 12-leads ECG or 24 Hour Holter monitoring) during the evaluation period (Day 91-365)


Secondary Outcome Measures :
  1. Secondary Safety- Cumulative incidence of primary adverse events [ Time Frame: 12 months ]
    o 12-Month PAE Rate: Cumulative incidence of primary adverse events occurring within seven (7) days following an AF ablation procedure using study catheters with EPU and any late onset atrio-esophageal fistula or PV stenosis through 12 months

  2. Secondary safety-Incidence of Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 12 months ]
    o Incidence of Unanticipated Adverse Device Effects (UADEs)

  3. Secondary Safety- Incidence of Serious Adverse Events (SAEs) [ Time Frame: 12 Months ]
    o Incidence of Serious Adverse Events (SAEs) within 7 days (early onset), >7 to 30 days (peri-procedural) and >30 days (late onset) of initial ablation

  4. Secondary Safety- Incidence of bleeding complication [ Time Frame: 12 Months ]
    o Incidence of bleeding complication: a) major bleeding, b) clinically relevant non-major, and c) minor bleeding as defined in the 2017 HRS/EHRA/ECAS/APHRS /SOLAECE Consensus Statement

  5. Secondary effectiveness: Acute procedural Success [ Time Frame: 12 months ]

    Acute Procedural success:

    • % of subjects with ipsilateral PVI (entrance block) at the end of the procedure
    • % of subjects with ipsilateral PVI (entrance block) after first encirclement (evaluated prior to the 30-minute waiting period and adenosine challenge)
    • % of subjects with ipsilateral PVI (entrance block) after first encirclement without acute reconnection, after waiting period and adenosine challenge
    • % of touch-up (ablation of acute reconnection) among all targeted veins
    • Anatomical location of acute PV reconnection after first encirclement

  6. Secondary- Effectiveness: Repeat ablation procedures post-procedure [ Time Frame: 12 Months ]

    Repeat Ablation Procedures:

    • Incidence (%) of repeat ablation procedures with VISITAG SURPOINT™ module during 12-months period post-procedure
    • % PVs re-isolated among all of the targeted PVs at repeat procedure
    • % repeat ablation procedures requiring new linear lesions and/or identifying new foci outside of initially isolated area among the repeat ablation procedures



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624881


Contacts
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Contact: Stephanie Lyke (949) 285- 7966 slyke@its.jnj.com
Contact: Tammy Footer (903) 505-0885 TFooter1@its.jnj.com

  Show 44 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.

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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT03624881     History of Changes
Other Study ID Numbers: BWI_2017_06
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes