Persistent Atrial FibrillationPerAF APACNCT04244396
Persistent Atrial Fibrillation (AF) APAC (Asia Pacific) Observational Study
An observational study of Persistent Atrial Fibrillation, run by Abbott Medical Devices at 9 sites in 5 countries.
Trial summary
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… 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™ (TactiCath SE)
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 25 Feb 2020to 30 Nov 2022
- Phase
- Observational
- 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
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.
Who may be able to join
- Signed informed consent
- Documented symptomatic persistent AF, defined as continuous AF sustained >7-days but <1 year documented by:
- Physician's note AND one of the following:
- 24-hr Holter showing continuous AF within 90-days of the procedure OR
- 2 ECGs (from any form of rhythm monitoring) showing continuous AF, taken at least 7-days apart
- 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
- ≥18 years of age
- Able and willing to complete all pre-, post-, and follow-up testing and requirements
Who cannot join
- Continuous AF >12 months (longstanding persistent AF)
- Previous left atrial (LA) surgical or catheter ablation for AF
- Any cardiac procedure within 90-days prior to initial procedure (Diagnostic procedures with no intervention are not considered a surgical or percutaneous surgical procedure)
- Coronary artery bypass graft (CABG) surgery within 6-months (180-days) prior to 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 (LA) diameter >50 mm (parasternal long axis view or by CT)
- Left Ventricular Ejection Fraction (LVEF) <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 12-months (365 days) prior to the initial procedure
- Rheumatic heart disease
- Uncontrolled heart failure or New York Heart Association (NYHA) 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 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
- 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
- History of atriotomy or ventriotomy
- Implanted left atrial appendage occlusion device
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
South Korea3 sites
Sejong Hospital
Bucheon-si
Severance Hospital, Yonsei University Health System
Seoul
Asan Medical Centre
Soeul
Singapore2 sites
National Heart Centre Singapore
Singapore
National University Hospital
Singapore
Taiwan2 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Taipei Veterans General Hospital
Taipei
About this study
Official title: 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.
Read the 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
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)
- Keywords
- Persistent Atrial Fibrillation, Radiofrequency Ablation, Heart Disease, Tachycardia, Cardiovascular Diseases, Cardiac Conduction System Disease, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation, Heart Diseases, Tachycardia, Cardiovascular Diseases, Cardiac Conduction System Disease
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™ (TactiCath SE)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug refractory, symptomatic persistent atrial fibrillation | Asian population Receives: Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device and/or Procedure-related Serious Adverse Events
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)
Measured: Through 7-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start25 Feb 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: The study was terminated early by the Sponsor as sufficient data had been collected to satisfy the study objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244396
- Sponsor's protocol ID
- ABT-CIP-10295
- Acronym
- PerAF APAC
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2020
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent AF (Asia Pacific) Observational Study
- ClinicalTrials.gov ID
- NCT04244396
- Acronym / sponsor ID
- PerAF APAC / ABT-CIP-10295
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Persistent Atrial Fibrillation, Radiofrequency Ablation, Heart Disease, Tachycardia, Cardiovascular Diseases, Cardiac Conduction System Disease, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the Sponsor as sufficient data had been collected to satisfy the study objectives.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug refractory, symptomatic persistent atrial fibrillation | – | Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)Asian population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Signed informed consent
- Documented symptomatic persistent AF, defined as continuous AF sustained >7-days but <1 year documented by:
- 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
- ≥18 years of age
- Able and willing to complete all pre-, post-, and follow-up testing and requirements
Key exclusion criteria (34 listed)
- Continuous AF >12 months (longstanding persistent AF)
- Previous left atrial (LA) surgical or catheter ablation for AF
- Any cardiac procedure within 90-days prior to initial procedure (Diagnostic procedures with no intervention are not considered a surgical or percutaneous surgical procedure)
- Coronary artery bypass graft (CABG) surgery within 6-months (180-days) prior to initial procedure
- Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Drug refractory, symptomatic persistent atrial fibrillation |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Ruffner study director
Abbott
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by Abbott Medical Devices at 9 sites in 5 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 8 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: stopped early, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea, Singapore, Taiwan, Hong Kong, Thailand. 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 19 Apr 2024). 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 Device and/or Procedure-related Serious Adverse Events (time frame: Through 7-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024; AzTrials last refreshed its copy on 3 Nov 2026.