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

NCT ID: NCT03624881

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2021-06-28

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.

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)

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Catheter ablation with EPU

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

New York Presbyterian

New York, New York, United States

Albert Einstein College of Medicine

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Oklahoma Heart Institute

Oklahoma City, Oklahoma, United States

Providence St Vincent Medical Center

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Greenville Health System

Greenville, South Carolina, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Texas Health Heart and Vascular Hospital

Arlington, Texas, United States

St. David's Medical Center

Austin, Texas, United States

Intermountain Medical

Murray, Utah, United States

Sentara Health

Norfolk, Virginia, United States

MultiCare Tacoma

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36137711 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BWI_2017_06

Identifier Type: -

Identifier Source: org_study_id