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Persistent Atrial FibrillationNCT03650556

Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

A study testing TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ in people with Persistent Atrial Fibrillation, run by Abbott Medical Devices at 22 sites in 2 countries.

Completed

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

Official record
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Trial summary

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
22 sitesin 2 countries
Study dates
28 Sep 2018to 11 Jan 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must provide written informed consent prior to any clinical investigation related procedure.
  • Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF
  • Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF
  • Age 18 years or older
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Who cannot join

  • Continuous AF > 12 months (longstanding persistent AF)
  • Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar
  • Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure
  • CABG surgery within the 6-months (180-days) prior to the initial procedure
  • Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
  • Any carotid stenting or endarterectomy
Show all 34Show fewer
  • Documented or known left atrial thrombus on imaging
  • Left atrial diameter > 50 mm (parasternal long axis view or by CT)
  • Left ventricular ejection fraction < 40%
  • Unable to take anticoagulation medication due to contraindication or intolerance
  • History of blood clotting or bleeding abnormalities
  • Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure
  • Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure
  • Rheumatic heart disease
  • Uncontrolled heart failure or NYHA functional 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 12-months (365 days) following the initial ablation procedure
  • Unstable angina at the time of the initial procedure
  • Acute illness or active systemic infection or sepsis
  • AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, major surgical procedure in the preceding 3-months, or other reversible or non-cardiac cause
  • Diagnosed atrial myxoma
  • Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (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
  • Significant congenital anomaly or other anatomic or comorbid medical problem that in the opinion of the investigator would preclude enrollment in this study or compliance with the follow-up requirements or impact the scientific soundness of the clinical trial results
  • Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
  • Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure
  • Presence of any condition that precludes appropriate vascular access or manipulation of catheter
  • Life expectancy less than 12-months
  • Body mass index > 40 kg/m2
  • Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  • Renal failure requiring dialysis
  • Vulnerable subject
  • History of atriotomy or ventriotomy
  • Implanted endocardial left atrial appendage occlusion device

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States20 sites

  • Emory University Hosptial

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • Johns Hopkins University Hospital

    Baltimore, Maryland, 21287

  • University Hospital (UAB)

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • St. Bernards

    Jonesboro, Arkansas, 72401

  • Scripps Health

    La Jolla, California, 92037

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • Arkansas Heart Hosptial

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Hospital

    New York, New York, 10016

  • Florida Hospital

    Orlando, Florida, 32803

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Sequoia Hospital

    Redwood City, California, 94062

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

Other trials in United States

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Melbourne Hospital - City Campus

    Parkville, Victoria, 3050

Other trials in Australia

About this study

Official title: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.

Being tested
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™Device

    Ablation procedure for Persistent AF

Study groups in NCT03650556
Study groupRoleWhat they receive
AblationExperimentalEnrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE).
Receives: Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

What is being measured

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

  1. Rate of Subjects With a Device and/or Procedure-related SAE.

    Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.

    Measured: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure

  2. Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.

    The following events were considered a failure for AF/AFL/AT recurrence:

    • If AF/AFL/AT recurrence (>30 second episode) occurred at any time after the therapy consolidation period (>180 days after the initial procedure), or
    • If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a >30 second AF/AFL/AT episode, or
    • If the subject required a second repeat procedure at any time after the initial procedure, or
    • If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or
    • If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or
    • If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the

    Measured: 15 months

Secondary outcomes (3)

  1. Acute Procedural Success

    Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins

    Measured: Immediate post procedure

  2. 15-month Success Off of Antiarrhythmic Drugs

    Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods.

    Measured: 15 months

  3. 15 Month Single Procedure Success

    Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.

    Measured: 15 months

Timeline

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

  1. First posted28 Aug 2018
  2. Study start28 Sep 2018
  3. Primary completion21 Dec 2020
  4. Study completion11 Jan 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03650556
Sponsor's protocol ID
ABT-CIP-10239
Status last verified
Jan 2022
First submitted
1 Aug 2018
Last updated
27 Apr 2022
Data monitoring committee
No
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 TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ in people with Persistent Atrial Fibrillation, run by Abbott Medical Devices at 22 sites in 2 countries.

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 5 inclusion and 34 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Australia. 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 27 Apr 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?

Rate of Subjects With a Device and/or Procedure-related SAE. (time frame: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure). 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 NCT03650556.

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 27 Apr 2022.

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