HD Mapping of Atrial Fibrillation in Asia Pacific

NCT04022954 | Completed Results DMC

• 1 other identifier: CRD975
• Study Type: observational
• Target: 200
• Locations: 5 countries
• Sites: 15

Brief Summary

The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.

  The rate of acute success was defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). This measure is presented here as the number of participants with acute success, and the associated percentage of subjects (proportion \* 100%) with acute success is also displayed as the result of an automatic calculation.

  End of Procedure

• Number of Participants With Clinical Long-Term Success

  Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion \* 100%) is also displayed as the result of an automatic calculation.

  12 months post-procedure

• Number of Participants With AAD-Free Long-Term Success

  Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion \* 100%) is also displayed as the result of an automatic calculation.

  12-month post-procedure

Secondary Outcomes (9)

• Overall Procedure Time

  During Procedure

• Radiofrequency (RF) Time

  During Procedure

• Fluoroscopy Time

  During Procedure

• Mapping Time Associated With Mapping Arrhythmia

  During Procedure

• Number of Mapping Points Collected

  During Procedure

Other Outcomes (3)

• Number of Participants With Adverse Events

  through study completion, an average of 1 year

• Number of Subjects With Repeat Ablations

  12-months post-procedure

• Change in Quality of Life (QoL): EQ-5D-5L VAS Score

  12-months post-procedure

Study Arms (2)

Inquiry™ AFocusII™ Double Loop

The Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart.

Device: Catheter ablation

Advisor™ HD Grid, Sensor Enabled™

The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Device: Catheter ablation

Interventions

Catheter ablation DEVICE

Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled

Advisor™ HD Grid, Sensor Enabled™; Inquiry™ AFocusII™ Double Loop

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The analysis population used for all endpoints will include all subjects who have signed the Informed Consent Form and have undergone the electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol. If any device used during the procedure is used off-label, the subject will be excluded from non-safety related endpoint analysis and any additional evaluations

You may qualify if:

• Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
• Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
• Subject is diagnosed with AF as defined by:
• Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
• Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
• Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
• Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation

You may not qualify if:

• Previous ablation or surgery in the left atria
• Implanted left atrial appendage occluder
• Implanted mitral or tricuspid valve replacement
• Implanted cardiac defibrillator (ICD)
• Participation in another clinical investigation that may confound the results of this study
• Pregnant or nursing
• Presence of other anatomic or comorbid conditions, or 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.
• Life expectancy less than 12 months

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (15)

Sir Run Run Shaw Hospital

Hangzhou, China

Location

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, 802-8555, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Yokosuka Kyosai Hospital

Kanagawa, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Japan

Location

Saga University Hospital

Saga, Japan

Location

Kitasato University Hospital

Sagamihara, Japan

Location

Kyorin University Hospital

Tama, Japan

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Taipei Veterans General Hospital (VGH)

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Principal Scientist Clinical Research
• Organization: Abbott

eric.horvath@abbott.com

1 202 253 5981

Study Officials

• Kristin Ruffner, PhD

  EP Program Director

  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
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 17, 2019
• Study Start: September 11, 2019
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); HK (1); CN (2); JP (8); TW (2)