Persistent Atrial Fibrillation (AF) APAC (Asia Pacific) Observational Study (PerAF APAC)

November 8, 2023 updated by: Abbott Medical Devices

Persistent AF (Asia Pacific) Observational Study

The objective of this clinical trial is to collect safety and effectiveness data for the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the APAC patient population for the treatment of drug refractory, symptomatic persistent atrial fibrillation when following standard electrophysiology mapping and radiofrequency (RF) ablation procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The PerAF APAC trial is a prospective, single arm, non-randomized, observational, post-market clinical investigation. Approximately 100 subjects will be enrolled at up to 15 sites in South Korea, Singapore, Hong Kong, Taiwan, and India. Centers in other countries within APAC may be approached for participation in the clinical investigation as needed. Subjects will be followed for 15-months after their initial ablation procedure. The primary effectiveness and safety endpoints will be evaluated through 15-months. A core lab will independently assess AF/Atrial Flutter (AFL)/(Atrial tachycardia (AT) recurrence via Holter monitoring at the 6-month and 15-month follow-up visits. All serious adverse events (SAEs) will be independently adjudicated by qualified physicians not participating in the trial

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Contacts and Locations

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

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Sejong Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System
      • Soeul, Korea, Republic of
        • Asan Medical Centre
  • Singapore
      • Singapore, Singapore
        • National University Hospital
      • Singapore, Singapore
        • National Heart Centre Singapore
  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
  • Thailand
      • Bangkok, Thailand
        • Phramongkutklao 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This clinical investigation will enroll drug refractory, symptomatic, persistent atrial fibrillation (AF) subjects who will undergo a de novo RF ablation procedure. Subjects must provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.

Description

Inclusion Criteria:

  1. Signed informed consent

  2. Documented symptomatic persistent AF, defined as continuous AF sustained >7-days but <1 year documented by:

    1. Physician's note AND one of the following:
    2. 24-hr Holter showing continuous AF within 90-days of the procedure OR
    3. 2 ECGs (from any form of rhythm monitoring) showing continuous AF, taken at least 7-days apart
  3. Refractory or intolerant to at least one Class I or III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF Note: Intolerant = unable, unwilling, or refusal to take AADs
  4. ≥18 years of age
  5. Able and willing to complete all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

  1. Continuous AF >12 months (longstanding persistent AF)
  2. Previous left atrial (LA) surgical or catheter ablation for AF
  3. Any cardiac procedure within 90-days prior to initial procedure (Diagnostic procedures with no intervention are not considered a surgical or percutaneous surgical procedure)
  4. Coronary artery bypass graft (CABG) surgery within 6-months (180-days) prior to initial procedure
  5. Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
  6. Any carotid stenting or endarterectomy
  7. Documented or known left atrial thrombus on imaging
  8. Left atrial (LA) diameter >50 mm (parasternal long axis view or by CT)
  9. Left Ventricular Ejection Fraction (LVEF) <40%
  10. Unable to take anticoagulation medication due to contraindication or intolerance
  11. History of blood clotting or bleeding abnormalities
  12. Myocardial Infarction (MI), acute coronary syndrome, Percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure
  13. Documented thromboembolic event (including TIA) within 12-months (365 days) prior to the initial procedure
  14. Rheumatic heart disease
  15. Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
  16. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
  17. Awaiting cardiac transplantation or other cardiac surgery within 12-months (365 days) following the initial ablation procedure
  18. Unstable angina at the time of the initial procedure
  19. Acute illness or active systemic infection or sepsis
  20. 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
  21. Diagnosed atrial myxoma
  22. Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
  23. 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
  24. 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
  25. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
  26. 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
  27. Presence of any condition that precludes appropriate vascular access or manipulation of catheter
  28. Life expectancy less than 12-months
  29. Body mass index >40 kg/m2
  30. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  31. Renal failure requiring dialysis
  32. 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
  33. History of atriotomy or ventriotomy
  34. Implanted left atrial appendage occlusion device

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Drug refractory, symptomatic persistent atrial fibrillation
Asian population
Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)
TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Device and/or Procedure-related Serious Adverse Events
Time Frame: Through 7-days

device and/or procedure-related serious adverse events are pre-defined as below with onset within 7-days of any ablation procedure that uses the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure)

  • Atrioesophageal fistula - assessed through 15 months
  • Cardiac tamponade/perforation - assessed through 15 months
  • Death
  • Heart block
  • Myocardial infarction (MI)
  • Pericarditis - pleuritic symptoms >7 days and/or requires hospitalization >24 hrs for reasons other than observational purposes only
  • Phrenic nerve injury resulting in diaphragmatic paralysis
  • Pneumothorax
  • Pulmonary edema (respiratory insufficiency)
  • Pulmonary vein stenosis - assessed through 15 months
  • Stroke/cerebrovascular accident
  • Thromboembolism
  • Transient ischemic attack
  • Vascular access complications (including major bleeding events)
Through 7-days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kristin Ruffner, Abbott

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABT-CIP-10295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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