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

NCT03624881 | Completed Phase 4 Results FDA Device

• 1 other identifier: BWI_2017_06
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 41

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Percentage of Participants With Cumulative PAEs

  Up to 12 months

• Number of Participants With Unanticipated Adverse Device Effects (UADEs)

  Up to 12 months

• Number of Participants With Serious Non-Primary AEs

  Up to 12 months

• Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset

  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

  End of the Procedure (up to 12 months)

Study Arms (1)

VISITAG SURPOINT Module with EPU

EXPERIMENTAL

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

Interventions

Catheter ablation with EPU 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

VISITAG SURPOINT Module with EPU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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)

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (41)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

CHI St. Vincent

Little Rock, Arkansas, 72205, United States

Location

Scripps Health

San Diego, California, 92037, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Marian Regional Medical Center

Santa Maria, California, 93454, United States

Location

St. John's Providence

Santa Monica, California, 90404, United States

Location

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Memorial Healthcare

Hollywood, Florida, 33021, United States

Location

Florida Hospital

Orlando, Florida, 92803, United States

Location

Baptist Hospital/Cardiology Consultants

Pensacola, Florida, 32501, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory St. Joseph's

Atlanta, Georgia, 30342, United States

Location

Evanston Community

Evanston, Illinois, 60201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Prairie Heart Institute

Springfield, Illinois, 62769, United States

Location

Baptist Health Lexington

Kensington, Kentucky, 40503, United States

Location

Oschner LSU Health Shreveport

Shreveport, Louisiana, 71103, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

New York Presbyterian

New York, New York, 10065, United States

Location

Albert Einstein College of Medicine

New York, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Providence St Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

Texas Health Heart and Vascular Hospital

Arlington, Texas, 76012, United States

Location

St. David's Medical Center

Austin, Texas, 78705, United States

Location

Intermountain Medical

Murray, Utah, 84107, United States

Location

Sentara Health

Norfolk, Virginia, 23507, United States

Location

MultiCare Tacoma

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 36137711 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Senior Safety Officer CSS
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 10, 2018
• Study Start: September 4, 2018
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: July 3, 2023
• Results First Posted: September 7, 2022

Record last verified: 2023-06

Locations

US (41)