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

Persistent Atrial Fibrillation Clinical Trial

— PerAF APAC  

Official title:

Persistent AF (Asia Pacific) Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04244396
• Other study ID #: ABT-CIP-10295
• Status: Terminated
• Start date: February 25, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 mapping and radiofrequency (RF) ablation procedures.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Through 7-days