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

NCT04244396 | Terminated Results DMC

• 1 other identifier: ABT-CIP-10295
• Study Type: observational
• Target: 82
• Locations: 5 countries
• Sites: 9

Brief 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.

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent Atrial Fibrillation; Radiofrequency Ablation; Heart Disease; Tachycardia; Cardiovascular Diseases; Cardiac Conduction System Disease; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Drug refractory, symptomatic persistent atrial fibrillation

Asian population

Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)

Interventions

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.

Drug refractory, symptomatic persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• hr Holter showing continuous AF within 90-days of the procedure OR
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (9)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

National Heart Centre Singapore

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Sejong Hospital

Bucheon-si, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Asan Medical Centre

Soeul, South Korea

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Phramongkutklao Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Diseases; Tachycardia; Cardiovascular Diseases; Cardiac Conduction System Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

In April 2022, communication was sent to sites informing them that enrollment was ending. The number of subjects enrolled at the time was deemed sufficient to assess the study endpoints while maintaining the study completion timelines. Follow-up was to continue as scheduled for those already enrolled and those enrolled prior to the end enrollment date of 30 April 2022. In September 2022, sufficient data had been collected so a decision was made to fully close the PerAF APAC clinical trial.

Results Point of Contact

• Title: Emily Jesser Clinical Research Scientist II
• Organization: Abbott_Medical_Devices

emily.jesser@abbott.com

6514482520

Study Officials

• Kristin Ruffner

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: February 25, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3); TW (2); SG (2); HK (1); TH (1)