This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
In the test group, subjects will undertake PVI using the PFA system including a nanosecond-scale pulsed field generator (InRythm, Insight Lifetech, Shenzhen, China), a lotos catheter that is expandable over the wire (LotosPFA, Insight Lifetech), and a customized 12-French steerable sheath (InBridge, Insight Lifetech).
In the control group, subjects will undergo PVI using an RFA system including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter (Biosense Webster Inc., Diamond Bar, CA, USA). PVI was performed with AI values of 400-450 in the anterior, 300-350 at the posterior wall of the LA.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
the 12-month treatment success rate
12month treatment success, is defined as freedom from any episodes of AF/atrial flutter (AFL)/atrial tachycardia (AT) without the use of Class I or III antiarrhythmic drugs (AADs) during the 12-month follow-up period after a 90-day blank period. An electrocardiogram or 24 h Holter monitoring should be performed to confirm all episodes. The occurrence of AF/AFL/AT during a blank period is not considered a treatment failure and can be treated with AADs (other than amiodarone), electric cardioversion, or only a time of catheter ablation procedure (the devices used during the redo procedure should be the same as those used in the original procedure). After the blanking period, any documentation of AF, AFL, or AT ≥ 30 s is considered a failure concerning the primary effectiveness endpoint. Following the blanking period, any use of a Class I or III AAD constitutes a treatment failure.
Time frame: during the 12-month follow-up period after a 90-day blank period.
Acute procedural success
Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.
Time frame: after a 20 min observation period following the last ablation.
Total procedure time
Procedure duration in minute
Time frame: During the procedure
Total left atrium indwelling time
Procedure duration in minute
Time frame: During the procedure
Total abaltion time
Procedure duration in minute
Time frame: During the procedure
Total X-ray exposure time
Total time of X-ray exposure
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Yan'an Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Sir Run Run Shaw Hospital
Hanzhou, Zhejiang, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Time frame: During the procedure
Total X-ray exposure dose
Total dose of X-ray exposure
Time frame: During the procedure
Number of participants under general anesthesia
Comparison of number of patients under general anesthesia between two groups.
Time frame: During the procedure
Evaluation of the ablation system（questionnaire）
To evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures : 1. the stability of the ablation system ; 2. the usability of the ablation system . For each system in 1., 2., and 3., only one of the following five ratings is given: 1. very stable; 2. stable, inspection was unaffected; 3. slightly unstable, inspection was unaffected; 4. N/A.
Time frame: immediately post ablation
Evaluation of the ablation catheter（questionnaire）
To evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures : 1. whether the ablation catheter can reach the expected position smoothly for ablation； 2. whether the ablation catheter can be visible clearly under X-ray； 3. whether the energy of the ablation catheter cannot be released after system operation
Time frame: immediately post ablation
Evaluation of the adjustable introducer sheath set（questionnaire）
To evaluate the adjustable introducer sheath set of the investigation device， including below measures : 1. whether the introducer sheath can reach the expected position smoothly for ablation； 2. whether the introducer sheath can be visible clearly under X-ray； 3. whether the curved shape of the introducer sheath can be adjustable。
Time frame: immediately post ablation
incidence of composite safety endpoint
Composite safety endpoint composed of: procedure-related deaths, strokes, and transient ischemic attacks
Time frame: 12 months after the ablation
incidence of surgical complications
surgical complications composed of: vascular puncture/bleeding complications, cardiac tamponades and/or perforations, left atrial-esophageal fistula, phrenic nerve injury, and pulmonary vein stenosis
Time frame: 12 months after the ablation
Incidence of severe adverse events
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time frame: 12 months after the ablation
Incidence of device-related adverse events
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.
Time frame: 12 months after the ablation