Phase 4
Completed N=333
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov NCT03624881 ↗
Enrolled (actual)
333
Serious AEs
19.0%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants With Primary Adverse Events (PAEs) — 11; 3 Participants
◆ Published Evidence
Established
27citations · ~7 / year
Composite Index Tagging for PVI in Paroxysmal AF: A Prospective, Multicenter Postapproval Study.
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.
Linked Publications
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Composite Index Tagging for PVI in Paroxysmal AF: A Prospective, Multicenter Postapproval Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Primary Adverse Events (PAEs) |
11; 3 | — |
| PRIMARY Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic) |
173; 34 | — |
| SECONDARY Percentage of Participants With Cumulative PAEs |
4.3; 6.3 | — |
| SECONDARY Number of Participants With Unanticipated Adverse Device Effects (UADEs) |
0; 0 | — |
| SECONDARY Number of Participants With Serious Non-Primary AEs |
42; 3 | — |
| SECONDARY Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure |
98.8; 100 | — |
| SECONDARY Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection |
72.0; 85.7 | — |
| SECONDARY Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins |
16.9; 7.1 | — |
| SECONDARY Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement |
4.2; 2.4; 3.5; 0.0; 3.9; 0.0 | — |
| SECONDARY Number of Participants Who Underwent Repeat Ablation Procedures |
14; 3 | — |
| SECONDARY Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure |
57.1; 100 | — |
| SECONDARY Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure |
64.3; 66.7 | — |
| SECONDARY Percentage of Participants With 12-Month Single Procedure Success |
55.5; 50.0 | — |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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.
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes vascular access, or manipulation of the catheter.
- Life expectancy less than 12 months
Data sourced from ClinicalTrials.gov (NCT03624881) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.