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

Completed · Phase 4

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03624881

Run by

Biosense Webster, Inc.

People needed

333

Starts

2018-09-04

Expected to finish

2021-06-28

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
• 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
• Failed at least one antiarrhythmic drug (AAD) (Class I or III antiarrhythmic drugs) as evidenced by recurrent symptomatic AF, or intolerable to the AAD
• Age 18 years or older
• Signed Patient Informed Consent Form (ICF)
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

You may not qualify if…

• Subjects who meet any of the following exclusion criteria are not eligible for enrollment.
• Previous surgical or catheter ablation for atrial fibrillation
• Previous cardiac surgery (including CABG) within the past 6 months (180 days)
• Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Any carotid stenting or endarterectomy
• Documented LA thrombus on imaging
• LA size > 50 mm (parasternal long axis view)
• LVEF < 40%
• Contraindication to anticoagulation (heparin or warfarin)
• History of blood clotting or bleeding abnormalities
• PCI/MI within the past 2 months (60 days)
• Documented thromboembolic event (including TIA) within the past 12 months (365 days)
• Rheumatic Heart Disease
• Uncontrolled heart failure or NYHA function class III or IV
• Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
• Unstable angina
• Acute illness or active systemic infection or sepsis
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Presence of implanted ICD/CRT-D.
• 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.
• Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including OTC medication)
• 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)
• Concurrent enrollment in an investigational study evaluating another device, biologic, or drug.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Grandview Medical Center — Birmingham, Alabama, United States
• Huntsville Hospital — Huntsville, Alabama, United States
• CHI St. Vincent — Little Rock, Arkansas, United States
• Scripps Health — San Diego, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• Marian Regional Medical Center — Santa Maria, California, United States
• St. John's Providence — Santa Monica, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• JFK Medical Center — Atlantis, Florida, United States
• Memorial Healthcare — Hollywood, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Baptist Hospital/Cardiology Consultants — Pensacola, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory St. Joseph's — Atlanta, Georgia, United States
• Evanston Community — Evanston, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Prairie Heart Institute — Springfield, Illinois, United States
• Baptist Health Lexington — Kensington, Kentucky, United States
• Oschner LSU Health Shreveport — Shreveport, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Abbott Northwestern — Minneapolis, Minnesota, United States
• Lovelace Medical Center — Albuquerque, New Mexico, United States
• Albany Medical Center — Albany, New York, United States
• NYU Langone — New York, New York, United States

Full record on ClinicalTrials.gov

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