Clinical trial NCT03624881: Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Number of Participants With Primary Adverse Events (PAEs)
timeFrame: Up to 12 months
measure: Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Participants With Cumulative PAEs
timeFrame: Up to 12 months
measure: Number of Participants With Unanticipated Adverse Device Effects (UADEs)
timeFrame: Up to 12 months
measure: Number of Participants With Serious Non-Primary AEs
timeFrame: Up to 12 months
measure: Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
timeFrame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months)
measure: Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure
timeFrame: End of the Procedure (up to 12 months)
measure: Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection
timeFrame: Up to 12 months
measure: Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins
timeFrame: Up to 12 months
measure: Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
timeFrame: Up to 12 months
measure: Number of Participants Who Underwent Repeat Ablation Procedures
timeFrame: Up to 12 months
measure: Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure
timeFrame: Up to 12 months
measure: Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure
timeFrame: Up to 12 months
measure: Percentage of Participants With 12-Month Single Procedure Success
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Little Rock
country: United States
facility: CHI St. Vincent
state: Arkansas
city: San Diego
country: United States
facility: Scripps Health
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Santa Maria
country: United States
facility: Marian Regional Medical Center
state: California
city: Santa Monica
country: United States
facility: St. John's Providence
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital/Cardiology Consultants
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory St. Joseph's
state: Georgia
city: Evanston
country: United States
facility: Evanston Community
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Heart Institute
state: Illinois
city: Kensington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Shreveport
country: United States
facility: Oschner LSU Health Shreveport
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Albuquerque
country: United States
facility: Lovelace Medical Center
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: New York Presbyterian
state: New York
city: New York
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Portland
country: United States
facility: Providence St Vincent Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Arlington
country: United States
facility: Texas Health Heart and Vascular Hospital
state: Texas
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical
state: Utah
city: Norfolk
country: United States
facility: Sentara Health
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Tacoma
state: Washington
Study officials:
References:
citation: 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.