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TactiFlex PAF IDE Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356040
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Prospective, non-randomized multi-center clinical investigation. Design includes a main study and a separate substudy. Subjects in the main study are to be treated using the full range of ablation power settings in the IFU. Subjects in the substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: TactiFlex SE Device: TactiFlex SE - HSP Not Applicable

Detailed Description:

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiFlexTM Ablation Catheter, Sensor EnabledTM (TactiFlex SE) for treating symptomatic drug-refractory paroxysmal atrial fibrillation. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiFlex SE catheter worldwide. Three hundred fifty-five (355) subjects will be enrolled at up to 40 investigational sites worldwide. This clinical investigation is sponsored by Abbott.

The TactiFlex IDE Clinical Study will enroll a total of 355 subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 355 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, non-randomized, multi-center pivotal clinical trial to evaluate the safety and effectiveness of ablation with the TactiFlex SE catheter for the treatment of PAF compared to pre-determined performance goals. The study design includes a substudy to assure that there will be a statistically sufficient number of subjects ablated at the high-end of the ablation power setting recommendations in the investigational Instructions for Use document. Subjects in the HSP (High Standard Power) substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power. Subjects will be enrolled in either the main study or the substudy at the point of consent.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Main Study Device: TactiFlex SE
Radiofrequency ablation with the TactiFlex SE ablation catheter to treat paroxysmal AF. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.

Experimental: HSP Sub-Study Device: TactiFlex SE - HSP
Radiofrequency ablation with the TactiFlex SE ablation catheter to treat paroxysmal AF. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.




Primary Outcome Measures :
  1. Rate of Device or Procedure-related Serious Adverse Events [ Time Frame: Through 12 months ]

    Outcome 1 is the rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below:

    • Atrio-esophageal fistula
    • Cardiac tamponade/perforation
    • Death
    • Heart block
    • Myocardial infarction
    • Pericarditis
    • Phrenic nerve injury resulting in diaphragmatic paralysis
    • Pulmonary edema
    • Pulmonary vein stenosis
    • Stroke/cerebrovascular accident
    • Thromboembolism
    • Transient ischemic attack
    • Vagal nerve injury/gastroparesis
    • Vascular access complications (including major bleeding events)

    Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12 months.


  2. Rate of freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence [ Time Frame: Through 12 months ]

    Outcome 2 for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).

    AF/AFL/AT recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation of AF/AFL/AT recurrence 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III AADs will not count as a therapy failure provided that only previously failed Class I or III AADs are taken at doses that do not exceed the previously failed dose.



Secondary Outcome Measures :
  1. Rate of freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence, without AADs [ Time Frame: Through 12 months ]

    Outcome 3 for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).

    AF/AFL/AT recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation of AF/AFL/AT recurrence 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, any use of a Class I or III AAD will count as an effectiveness failure.


  2. Rate of freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence with only 1 ablation procedure [ Time Frame: 12 months ]

    Outcome 4 for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).

    AF/AFL/AT recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. Any repeat ablation procedure in the left atrium will be considered a treatment failure. Failure to achieve acute procedural success during the ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III AADs will not count as a therapy failure provided that only previously failed Class I or III AADs are taken at doses that do not exceed the previously failed dose.


  3. Rate of freedom from symptomatic atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence [ Time Frame: Through 12 months ]

    Outcome 5 for this clinical trial is freedom from documented symptomatic AF/AFL/AT episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period).

    AF/AFL/AT recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation of AF/AFL/AT recurrence 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III AADs will not count as a therapy failure provided that only previously failed Class I or III AADs are taken at doses that do not exceed the previously failed dose.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient will be eligible for clinical trial participation if he/she meets the following criteria:

  1. Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug.
  2. Physician's note indicating recurrent self-terminating AF
  3. One electrocardiographically documented AF episode within 6-months prior to the initial ablation procedure.
  4. At least 18 years of age
  5. Able and willing to comply with all trial requirements
  6. Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

Exclusion Criteria:

A patient will be excluded from enrollment in the clinical trial if he/she meets any of the following criteria:

  1. Persistent or long-standing persistent atrial fibrillation
  2. Active systemic infection
  3. Known presence of cardiac thrombus
  4. Hypertrophic cardiomyopathy
  5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the 90-day period preceding procedure
  6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within 90 days of procedure
  7. Left atrial diameter > 5.0 cm measured within 180 days of procedure (echocardiography or CT)
  8. Left ventricular ejection fraction < 35% measured within 180 days of procedure (echocardiography or CT)
  9. New York Heart Association (NYHA) class III or IV
  10. Previous left atrial surgical or catheter ablation procedure
  11. Left atrial surgical procedure or incision with resulting scar (including LAA closure device)
  12. Previous tricuspid or mitral valve replacement or repair
  13. Heart disease in which corrective surgery is anticipated within 180 days after the procedure
  14. Bleeding diathesis or suspected pro-coagulant state
  15. Contraindication to long term anti-thromboembolic therapy
  16. Presence of any condition that precludes appropriate vascular access
  17. Renal failure requiring dialysis
  18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  19. Severe 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 severe chronic symptoms
  20. Women who are pregnant or breastfeeding
  21. Presence of other anatomic or comorbid condition that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
  22. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial
  23. Patient is unlikely to survive the protocol follow up period of 12-months after the procedure
  24. Body mass index > 40 kg/m2
  25. Presence of other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  26. Individuals without legal authority
  27. Individuals unable to read or write
  28. Patients who have had a ventriculotomy or atriotomy within the preceding 4 weeks of procedure,
  29. Patients with prosthetic valves,
  30. Patients with a myxoma,
  31. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
  32. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.
  33. Stroke or TIA (transient ischemic attack) within the last 90 days
  34. Stent, constriction, or stenosis in a pulmonary vein.
  35. Rheumatic heart disease
  36. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).

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): NCT04356040


Contacts
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Contact: George Galoussian 818 493 2156 george.galoussian@abbott.com
Contact: Eric Grovender 6517564067 eric.grovender@abbott.com

Locations
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United States, Arkansas
St. Bernards Medical Center Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Kayla Rubino         
Principal Investigator: Devi Nair         
United States, Michigan
Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Candice Edillo         
Principal Investigator: Dipak Shah         
United States, Mississippi
Jackson Heart Clinic Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, New York
New York-Presbyterian/Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Paul Gonzalez         
Principal Investigator: Deepak Saluja         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Active, not recruiting
Austin, Texas, United States, 78705
Australia, Queensl
Wesley Private Hospital Not yet recruiting
Auchenflower, Queensl, Australia, 4066
Contact: Kirt Myers         
Principal Investigator: Deepak Arumugam         
The Prince Charles Hospital Recruiting
Chermside, Queensl, Australia, 4032
Contact: Megan Mearns         
Principal Investigator: Haris Haqqani         
Australia, Victori
Monash Medical Centre Recruiting
Clayton, Victori, Australia, 3168
Contact: Debra O'Leary         
Principal Investigator: Stewart Healy         
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia, 5067
Contact: Jun Lin         
Principal Investigator: Prash Sanders         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Kristin Ruffner Clinical Program Director
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04356040    
Other Study ID Numbers: ABT-CIP-10303
CRD_978 ( Other Identifier: Abbott )
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes