Atrial Fibrillation
Conditions
Brief summary
The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).
Interventions
None listed
Sponsors
Johnson & Johnson Medical (Shanghai) Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with I and/or III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III AAD based on medical records * Age 18-80 years * Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements * Signed patient informed consent form (ICF)
Exclusion criteria
* Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause * Previous left atrium (LA) ablation or surgery * Left atrium diameter (LAD) greater than (\>) 50 millimeters (mm) by transthoracic echocardiography (TTE) * Left ventricular ejection fraction (LVEF) less than (\<) 40 percent (%) * Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study * Current enrollment in an investigational study evaluating another device or drug * Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Life expectancy less than 12 months * Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU) * Presenting contra-indications for catheter ablation at physicians' discretion, for example LA/Left atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access * Other conditions that, at discretion of the investigators, would preclude enrollment in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode | Day 91 to Day 365 post index procedure | Participants reporting freedom from documented (asymptomatic and symptomatic) atrial tachyarrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episode based on 24-hour Holter will be reported. Additionally, criteria for effectiveness failure included following: 1) Greater (\>) than 1 repeat ablations for AF, AT, and AFL of unknown origin in the blanking period or any repeat ablation or surgical treatment for AF, AT, and AFL of unknown origin; 2) Direct current or pharmacological cardioversion for AF, AT, and AFL of unknown origin and; 3) A Class I and/or Class III antiarrhythmic drugs (AAD) is prescribed for AF, AT, and AFL of unknown origin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeat Ablation | Up to 12 months post-index procedure | Participants undergoing repeat ablation within the 12 month follow up period, including timing (blanking period or after blanking) will be reported. |
| PV Re-Connection | Up to 12 months post-index procedure | Participants reporting PV re-connection during repeat ablation will be assessed and reported. |
| Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, and AFL | Day 91 to Day 365 post index procedure | Participants reporting freedom from documented (asymptomatic and symptomatic) atrial tachyarrhythmias (AF, AT or AFL of unknown origin) lasting \>= 30 seconds based on mobile electrocardiogram (ECG) during the effectiveness evaluation period will be reported. |
| Acute Procedural Success | Intraoperative | Acute procedural success, which is defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after drugs challenge or pacing at the end of the index ablation procedure will be reported. |
| Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire Score | Baseline, up to 12 months post-index procedure | The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms. |
| Total Procedure Time | Intraoperative | Total procedure time will be reported. |
| Mapping Time | Intraoperative | Mapping time will be reported. |
| Pulsed Field Ablation (PFA) Application Time | Intraoperative | PFA application time will be reported. |
| Number of PFA Ablation | Intraoperative | Number of PFA ablation will be reported. |
| Total Fluoroscopy Time | Intraoperative | Total fluoroscopy time will be reported. |
| Study Catheter Dwell Time | Intraoperative | Dwell time is defined as time from first Varipulse catheter insertion in LA until removal from LA. |
| Ablation Settings Used | Intraoperative | The ablation parameters setting used for the procedure will be reported. |
| Participant Electrophysiology (EP) Lab Time | Intraoperative | Participant EP lab time is defined as the time taken for participant on table to leave table, including induction and awakening. |
| Richmond Agitation-Sedation Scale Score (RASS) | Intraoperative | RASS ranges from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. |
| Pain Visual Analogue Scale (VAS) Score | Prior to Discharge (up to Day 1 post-index procedure) | VAS score will be measured for intraprocedural pain, discomfort and anxiety and post-procedural groin pain, throat pain and chest pain prior to hospital discharge using 100- point VAS, where 0 = no pain/anxiety/comfort, 100 = worst imaginable pain/anxiety/discomfort. Higher score means greater severity. |
| Participant's Movements During Ablation | Intraoperative | Participant's significant movements causing map shifting or CARTO "learning new" warning, and coughs will be reported. Phrenic nerve stimulation not included. |
| Percentage of Participants who Switch from Non-General Anesthesia (GA) to GA | Intraoperative | Percentage of participants who need to switch from non-GA to GA will be reported. |
| Acute Reconnection | Intraoperative | Participants with acute reconnection, which is identified by drugs challenge or pacing among all clinically relevant targeted PVs will be reported. |
| Use of Paralytics and Anesthesia, and Related Drug Details | Intraoperative | Number of participants reporting the use of paralytics and anesthesia, and related drug details will be reported. |
Contacts
CONTACTYanTing Zhang
STUDY_DIRECTORJohnson & Johnson Medical (Shanghai) Ltd. Clinical Trial
Johnson & Johnson Medical (Shanghai) Ltd.
Outcome results
None listed