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Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation. (QDOT-FAST)

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ClinicalTrials.gov Identifier: NCT03459196
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: THERMOCOOL SMARTTOUCH SF-5D Catheter Not Applicable

Detailed Description:

The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : October 8, 2018
Actual Study Completion Date : October 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including TGA mode (Temperature Guided Ablation).
Device: THERMOCOOL SMARTTOUCH SF-5D Catheter
radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode




Primary Outcome Measures :
  1. Acute Device Performance [ Time Frame: Intraoperative ]
    Acute Procedural Success defined as confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge.


Secondary Outcome Measures :
  1. Incidence of Primary Adverse Events (PAEs) (within 7 days of the initial mapping and ablation procedure). [ Time Frame: 7 days ]

    The incidence of Primary Adverse Events (PAEs) (within 7 days of the initial mapping and ablation procedure). PAEs include the following AEs:

    • Atrio-esophageal Fistula
    • Cardiac Tamponade/perforation
    • Death
    • Major Vascular Access Complication/Bleeding
    • Myocardial Infarction
    • Phrenic Nerve Paralysis
    • Pulmonary Vein Stenosis
    • Stroke/CVA
    • Thromboembolism
    • TIA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 or older.
  2. Signed the Patient Informed Consent Form (ICF).
  3. Diagnosed with symptomatic PAF
  4. Selected for catheter ablation through pulmonary vein isolation.
  5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patient not confined by a court ruling).

Exclusion Criteria:

  1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  2. Previous surgical or catheter ablation for atrial fibrillation.
  3. Previously diagnosed with persistent, longstanding AF and/or continuous AF >7 days, or >48 hrs. terminated by cardioversion.
  4. Documented Left Atrial thrombus on baseline/pre-procedure imaging.
  5. Any carotid stenting or endarterectomy.
  6. Left atrial (LA) size >50mm.
  7. Left Ventricular ejection fraction (LVEF) <40%.
  8. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
  9. History of blood clotting or bleeding abnormalities
  10. Contraindication to anticoagulation
  11. History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months.
  12. Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months.
  13. Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
  14. Rheumatic Heart Disease
  15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
  16. Unstable angina.
  17. Significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other diseaseor malfunction of the lungs or respiratory system that produces chronic symptoms.
  18. Acute illness, active systemic infection, or sepsis.
  19. Presence of atrial myxoma, interatrial baffle or patch
  20. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  21. Presence of a condition that precludes vascular access.
  22. Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD).
  23. Presence of IVC filter
  24. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
  25. Currently enrolled in an investigational study evaluating another device, biologic, or drug.
  26. 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.
  27. Life expectancy or other disease processes likely to limit survival to less than 12 months.
  28. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
  29. Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
  30. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
  31. Presence of iron-containing metal fragments in the body
  32. Unresolved pre-existing neurological deficit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459196


Locations
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Austria
Elisabethinen Hospital
Linz, Austria
Belgium
OLV Aalst
Aalst, Belgium
AZ Sint-Jan
Brugge, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Czechia
Ceské Budejovice Hospital
Ceské Budejovice, Czechia
Na Homolce
Prague, Czechia
Italy
Ospedale F Miulli
Bari, Italy
Sponsors and Collaborators
Biosense Webster, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT03459196     History of Changes
Other Study ID Numbers: BWI_2017_02
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Biosense Webster, Inc.:
Interventional
Radiofrequency Ablation
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes