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| Name | Class |
|---|---|
| Insight Lifetech Co., Ltd. | INDUSTRY |
| Guangdong Provincial People's Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Sir Run Run Shaw Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Test group will utilize the cardiac PFA system (including a pulsed field generator, an expandable PFA catheter, and a steerable sheath) from Insight Medtech. |
|
| Control group | Active Comparator | The control group will utilize an RFA system (including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter) from Biosense Webster. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation (PFA) Therapy | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during the 12-month follow-up period after a 90-day blank period. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedural success | Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation. | after a 20 min observation period following the last ablation. |
| Total procedure time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | China | |||
| Xiamen Cardiovascular Hospital, Xiamen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41338842 | Derived | Lin W, Chu H, Wang C, Chang D, Yin X, Wang Y, Jiang C, Xu Y, Liao Q, Yang J, Zhu W, Li S, Gao W, Chen Y, Yu Y, Li Q, Liao H, Deng H, Wei W, Pu S, Guo Z, Xu D, Li W, Ouyang F, Xue Y; InsightPFA Investigators. Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial. J Am Coll Cardiol. 2025 Dec 9;86(23):2314-2326. doi: 10.1016/j.jacc.2025.09.1593. | |
| 39853845 |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| The Affiliated People's Hospital of Ningbo University | OTHER_GOV |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Xiamen Cardiovascular Hospital, Xiamen University | OTHER |
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
| Weifang People's Hospital | OTHER |
symptomatic paroxysmal AF
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| Radiofrequency Ablation（RAF）Therapy | Device | 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. |
|
Procedure duration in minute
| During the procedure |
| Total left atrium indwelling time | Procedure duration in minute | During the procedure |
| Total abaltion time | Procedure duration in minute | During the procedure |
| Total X-ray exposure time | Total time of X-ray exposure | During the procedure |
| Total X-ray exposure dose | Total dose of X-ray exposure | During the procedure |
| Number of participants under general anesthesia | Comparison of number of patients under general anesthesia between two groups. | 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 :
For each system in 1., 2., and 3., only one of the following five ratings is given:
| 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 :
| 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 :
| immediately post ablation |
| incidence of composite safety endpoint | Composite safety endpoint composed of: procedure-related deaths, strokes, and transient ischemic attacks | 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 | 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. | 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. | 12 months after the ablation |
| Xiamen |
| Fujian |
| China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| 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 |
| Derived |
| Lin W, Pu S, Chu H, Chang D, Yin X, Wang Y, Xu Y, Li S, Yang J, Zhu W, Li S, Gao W, Chen Y, Xu D, Jiang C, Xue Y. Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation. J Cardiovasc Electrophysiol. 2025 Mar;36(3):632-641. doi: 10.1111/jce.16573. Epub 2025 Jan 24. |