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Paroxysmal Atrial FibrillationNCT04356040

TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

A study testing TactiFlex SE and TactiFlex SE - High Standard Power in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 45 sites in 10 countries.

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 parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
TactiFlex SE and TactiFlex SE - High Standard Power
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
355 participants
Where
45 sitesin 10 countries
Study dates
29 Jun 2020to 1 Jul 2022
Phase
Interventional
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 paroxysmal atrial fibrillation
  2. Physician's note indicating recurrent self-terminating atrial fibrillation
  3. One electrocardiographically documented atrial fibrillation episode within 12-months prior to informed consent/enrollment. Documented evidence of the atrial fibrillation episode must either be continuous atrial fibrillation on a 12-lead ECG or include at least 30 seconds of atrial fibrillation from another ECG device.
  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 of the respective clinical trial site.

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, acute coronary syndrome, percutaneous coronary intervention, 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 computerized tomography)
  8. Left ventricular ejection fraction < 35% measured within 180 days of procedure (echocardiography or computerized tomography)
  9. New York Heart Association class III or IV
  10. Previous left atrial surgical or catheter ablation procedure
  11. Left atrial surgical procedure or incision with resulting scar (including left atrial appendage 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 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).

Trial locations and contacts

45 sites in 10 countries.

45 sites in 10 countries

United States30 sites

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30309

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Affinity Cardiovascular Specialists, LLC

    Birmingham, Alabama, 35243

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Kootenai Heart Clinics

    Coeur d'Alene, Idaho, 83814

  • Ohio State University

    Columbus, Ohio, 43210

  • Memorial Hermann Hospital

    Houston, Texas, 77380

  • St. Vincent Hospital

    Indianapolis, Indiana, 46260

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • Scripps Health

    La Jolla, California, 92037

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Hospital

    New York, New York, 10016

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032

  • AdventHealth Orlando

    Orlando, Florida, 32806

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75204

  • NC Heart & Vascular Research

    Raleigh, North Carolina, 27607

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California, 92103

  • Providence Hospital

    Southfield, Michigan, 48075

  • Franciscan Heart & Vascular Associates

    Tacoma, Washington, 98405

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

Other trials in United States

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, 5067

  • Wesley Private Hospital

    Auchenflower, Queensl, 4066

  • The Prince Charles Hospital

    Chermside, Queensl, 4032

  • Monash Medical Centre

    Clayton, Victori, 3168

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada2 sites

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Germany2 sites

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, N. RHIN, 32545

  • Herzzentrum Leipzig GmbH

    Leipzig, 4289

Other trials in Germany

Austria1 site

  • A. ö. Krankenhaus der Elisabethinen Linz

    Linz, UPR AUS, 4020

Other trials in Austria

Czechia1 site

  • IKEM Prague

    Prague, Cbohmia, 14021

Other trials in Czechia

Hong Kong1 site

  • Prince of Wales Hospital

    Hong Kong, HONG KO

Other trials in Hong Kong

Italy1 site

  • Ospedale San Raffaele

    Milan, Lombard, 20132

Other trials in Italy

Netherlands1 site

  • Erasmus MC - Thoraxcenter

    Rotterdam, S Holln, 3015

Other trials in Netherlands

Taiwan1 site

  • Taipei Veterans General Hospital (VGH)

    Taipei, Ntaiwan, 11217

Other trials in Taiwan

About this study

Official title: Safety and Effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for Treating Drug-refractory, Symptomatic Atrial Fibrillation.

Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Read the detailed description

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for treating drug-refractory, symptomatic paroxysmal atrial fibrillation. This clinical investigation will be conducted under an investigational device exemption and is intended to support market approval of the TactiFlex SE catheter worldwide. Three hundred and Fifty Five (355) subjects will be enrolled at up to 50 investigational sites worldwide. This clinical investigation is sponsored by Abbott.

Being tested
TactiFlex SE, TactiFlex SE - High Standard Power
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • TactiFlex SEDevice

    Also called TactiFlex Sensor Enabled Ablation Catheter

    Radiofrequency ablation with the TactiFlex SE ablation catheter. 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.

  • TactiFlex SE - High Standard PowerDevice

    Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the 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.

Study groups in NCT04356040
Study groupRoleWhat they receive
Main StudyExperimentalNot described
Receives: Device: TactiFlex SE
High Standard Power Sub-StudyExperimentalNot described
Receives: Device: TactiFlex SE - High Standard Power

What is being measured

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

  1. Number of Participants With Device or Procedure-related Serious Adverse Events

    Tthe 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 fistula1
    • Cardiac tamponade/perforation1
    • Death
    • Heart block
    • Myocardial infarction
    • Pericarditis
    • Phrenic nerve injury resulting in diaphragmatic paralysis
    • Pulmonary edema
    • Pulmonary vein stenosis1
    • Stroke/cerebrovascular accident
    • Thromboembolism
    • Transient ischemic attack
    • Vagal nerve injury/gastroparesis
    • Vascular access complications (including major bleeding events)
    1. Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12-months.

    Measured: Through 12 months

  2. KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence

    Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period will not be considered a treatment failure. One repeat procedure will be allowed during the blanking period. 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 anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed drugs are taken at doses that do not exceed the previously failed dose.

    Measured: Through 12 months

Secondary outcomes (3)

  1. KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence

    Freedom from documented symptomatic atrial fibrillation/atrial flutter/atrial tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. 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 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 anti-arrhythmias drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmias drugs are taken at doses that do not exceed the previously failed dose.

    Measured: Through 12 months

  2. KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure

    Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. 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 anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmic drugs are taken at doses that do not exceed the previously failed dose.

    Measured: 12 months

  3. KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs

    Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period). 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 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 anti-arrhythmic drugs will count as an effectiveness failure.

    Measured: Through 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 posted21 Apr 2020
  2. Study start29 Jun 2020
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is a prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
Masking
None (open label)
Enrolment
355 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356040
Sponsor's protocol ID
ABT-CIP-10303
Other IDs
CRD_978
Status last verified
Oct 2023
First submitted
15 Apr 2020
Last updated
31 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TactiFlex SE and TactiFlex SE - High Standard Power in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 45 sites in 10 countries.

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

Who may be eligible to take part?

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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Australia, Canada, Germany, Austria and 5 more countries. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2023). 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 Device or Procedure-related Serious Adverse Events (time frame: Through 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 NCT04356040.

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 31 Oct 2023.

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TactiFlex Paroxysmal Atrial Fibrillation IDE Trial | AzTrials