A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF (SMARTPULSE PAF)

March 26, 2024 updated by: Biosense Webster, Inc.

Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)

The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Not yet recruiting
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35243
        • Not yet recruiting
        • Grandview Medical Center
    • California
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Keck School of Medicine of USC
      • San Francisco, California, United States, 94109
        • Withdrawn
        • California Pacific Medical Center- Sutter Health
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • HCA Florida JFK Hospital
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Ascension St. Vincent's
      • Miami, Florida, United States, 33133
        • Recruiting
        • HCA Florida Mercy Hospital
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
    • Georgia
      • Macon, Georgia, United States, 31201
        • Not yet recruiting
        • Georgia Arrhythmia Consultants and Research Institute
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
      • Maywood, Illinois, United States, 60153
        • Not yet recruiting
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • University of Kansas Medical Center
      • Overland Park, Kansas, United States, 662111
        • Not yet recruiting
        • The Kansas City Heart Rhythm Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40205
        • Not yet recruiting
        • Norton Heart Specialist
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Not yet recruiting
        • Tulane University Heart & Vascular Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Not yet recruiting
        • Trinity Health Michigan Heart - Ann Arbor Campus
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Recruiting
        • Cardiovascular Associates of the Delaware Valley
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Withdrawn
        • Lovelace Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Not yet recruiting
        • Montefiore Medical Center
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Heart Rhythm Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Not yet recruiting
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Ohio State University
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Mansfield Hospital
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Trident Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Research Foundation
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
      • San Antonio, Texas, United States, 78201
        • Not yet recruiting
        • Methodist Texsan
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) with (a) at least two symptomatic atrial fibrillation (AF) episodes within last six months from enrollment and (b) at least one AF episode electrocardiographically documented by electrocardiogram (ECG); transtelephonic monitoring (TTM), Holter monitor, telemetry strip or implanted device within 12 months prior to enrollment
  • Failed at least one antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable side effects to the AAD, or contraindication to the AAD
  • Willing and capable of providing consent
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
  • Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
  • Previous left atrium (LA) ablation or surgery
  • Participants known to require ablation outside the pulmonary vein (PV) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia, and Wolff-Parkinson-White), except cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter
  • Documented severe dilatation of the LA (left anterior descending artery [LAD] >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment
  • Documented LA thrombus by imaging within 48 hours of the procedure
  • Documented severely compromised left ventricular ejection fraction (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to enrollment
  • Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
  • History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure
  • Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months
  • Participants with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months
  • Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
  • Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
  • Unstable angina within 6 months
  • Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
  • Significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
  • Significant congenital anomaly (for example, atrial septal defects [ASDs]) including repaired defects or medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Prior diagnosis of pulmonary vein stenosis
  • Pre-existing hemi diaphragmatic paralysis
  • Acute illness, active systemic infection, or sepsis
  • Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
  • Severe mitral regurgitation (Regurgitant volume greater than or equal to [>=] 60 milli liter (mL)/beat, Regurgitant fraction >= 50%, and/or Effective regurgitant orifice area >= 0.40 cm^2)
  • Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) left atrial appendage occlusion (LAAO) device or other implanted metal cardiac device within cardiac space that may interfere with the energy field created during the ablation procedure
  • Presence of a condition that precludes vascular access
  • Current enrollment in an investigational study evaluating another device or drug
  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
  • Life expectancy less than 12 months
  • Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Participants with drug refractory, symptomatic paroxysmal atrial fibrillation will receive PFA /radiofrequency (RF) ablation using THERMOCOOL STSF catheter in conjunction with the TRUPULSE generator per the hospital's standard protocol (at discretion of investigator).
Device: THERMOCOOL STSF Bi- Directional Navigation Catheter
THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.
Device: TRUPULSE Generator
TRUPULSE Generator will be used to deliver PF/RF ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Primary Adverse Events (PAEs)
Time Frame: 7 days post-procedure
PAEs occurring within 7 days of an ablation which uses the BWI ablation system (including atrio-esophageal fistula and pulmonary vein stenosis occurring greater than 7 days of post ablation procedure) will be reported.
7 days post-procedure
Percentage of Participants with Freedom from Documented (Symptomatic and Asymptomatic) Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes and Other Failure Modes
Time Frame: Up to 274 days
The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic AF, AT, or AFL will be reported.
Up to 274 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Quality-of-Life (QOL) Improvement
Time Frame: From baseline to 12 months post ablation procedure
Quality of life will be assessed as measured by the total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire score. The score ranges from 0 to 100, with higher scores indicating better quality of life.
From baseline to 12 months post ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Investigators

  • Study Director: Biosense Webster Inc. Clinical Trial, Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWI202204 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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