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Paroxysmal Atrial FibrillationPhase 4NCT03624881

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

A Phase 4 study testing Catheter ablation with EPU in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
Catheter ablation with EPU
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
41 sitesUnited States
Study dates
4 Sep 2018to 28 Jun 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Lovelace Medical Center

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Health Heart and Vascular Hospital

    Arlington, Texas, 76012

  • Emory St. Joseph's

    Atlanta, Georgia, 30342

  • JFK Medical Center

    Atlantis, Florida, 33462

  • St. David's Medical Center

    Austin, Texas, 78705

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • University of Colorado Denver

    Denver, Colorado, 80204

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Evanston Community

    Evanston, Illinois, 60201

  • Greenville Health System

    Greenville, South Carolina, 29605

  • Memorial Healthcare

    Hollywood, Florida, 33021

  • Huntsville Hospital

    Huntsville, Alabama, 35801

  • Baptist Health Lexington

    Kensington, Kentucky, 40503

  • CHI St. Vincent

    Little Rock, Arkansas, 72205

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Abbott Northwestern

    Minneapolis, Minnesota, 55407

  • Intermountain Medical

    Murray, Utah, 84107

  • NYU Langone

    New York, New York, 10016

  • New York Presbyterian

    New York, New York, 10065

  • Albert Einstein College of Medicine

    New York, New York, 10467

  • Sentara Health

    Norfolk, Virginia, 23507

  • Oklahoma Heart Institute

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital

    Orlando, Florida, 92803

  • Baptist Hospital/Cardiology Consultants

    Pensacola, Florida, 32501

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Providence St Vincent Medical Center

    Portland, Oregon, 97225

  • Scripps Health

    San Diego, California, 92037

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Marian Regional Medical Center

    Santa Maria, California, 93454

  • St. John's Providence

    Santa Monica, California, 90404

  • Oschner LSU Health Shreveport

    Shreveport, Louisiana, 71103

  • Prairie Heart Institute

    Springfield, Illinois, 62769

  • MultiCare Tacoma

    Tacoma, Washington, 98405

  • Tampa General Hospital

    Tampa, Florida, 33606

Other trials in United States

About this study

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)

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.

Read the 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)
Being tested
Catheter ablation with EPU
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter ablation with EPUDevice

    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

Study groups in NCT03624881
Study groupRoleWhat they receive
VISITAG SURPOINT Module with EPUExperimentalSubjects 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
Receives: Device: Catheter ablation with EPU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 12 months

  2. 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.

    Measured: Up to 12 months

Secondary outcomes (12)

  1. Percentage of Participants With Cumulative PAEs

    A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs 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.

    Measured: Up to 12 months

  2. Number of Participants With Unanticipated Adverse Device Effects (UADEs)

    Number of participants with UADEs was reported.

    Measured: Up to 12 months

  3. Number of Participants With Serious Non-Primary AEs

    Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. 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.

    Measured: Up to 12 months

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

    Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (>=) 2 grams per deciliter (g/dL), transfusion of >= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.

    Measured: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months)

  5. Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure

    Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported.

    Measured: End of the Procedure (up to 12 months)

  6. Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection

    Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported.

    Measured: Up to 12 months

  7. Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins

    Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported.

    Measured: Up to 12 months

  8. Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement

    Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV).

    Measured: Up to 12 months

  9. Number of Participants Who Underwent Repeat Ablation Procedures

    Number of participants who underwent repeat ablation procedures were reported.

    Measured: Up to 12 months

  10. Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure

    Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported.

    Measured: Up to 12 months

  11. Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure

    Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure was reported.

    Measured: Up to 12 months

  12. Percentage of Participants With 12-Month Single Procedure Success

    Percentage of participants with 12-month single procedure success was reported. It is defined as freedom from 1) any repeat procedure for Atrial fibrillation (AF)/Atrial tachycardia (AT)/Atrial flutter (AFL) post index procedure; 2) any class I/III AAD taking during the evaluation period; 3) documented AF/AT/AFL recurrence in evaluation period.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start4 Sep 2018
  3. Primary completion28 Jun 2021
  4. Study completion28 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624881
Sponsor's protocol ID
BWI_2017_06
Status last verified
Jun 2023
First submitted
26 Jul 2018
Last updated
3 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 36137711

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Catheter ablation with EPU in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Primary Adverse Events (PAEs) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03624881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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