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Paroxysmal supraventricular tachycardia known as PSVT includes atrioventricular reentrant tachycardia (AVRT) and atrioventricular nodal reentrant tachycardia (AVNRT).
This study is multicenter, retrospective, cohort study. This study will collect real world data of AVNRT and AVRT cohorts retrospectively to evaluate the effectiveness and safety in real world clinical practice. 300 subjects with PSVT will be consecutively enrolled backwards since 02 Nov 2017, and at least 100 subjects for each cohort.
Cohort one: AVNRT Cohort two: AVRT, including Wolff-Parkinson-White syndrome（WPW）
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVNRT | atrioventricular nodal reentrant tachycardia |
| |
| AVRT | atrioventricular reentrant tachycardia, including Wolff-Parkinson-White syndrome（WPW） |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter | Device | THERMOCOOL SMARTTOUCH® catheter is a pressure catheter irrigated with cold saline, contact force sensing catheter. When used with Carto ®3 system, this catheter can provide a real time measurement for contact force. The magnitude and direction of the contact force can be displayed visually in the form of vector arrow on the top of catheter in Carto®3 system. It can be used for electrophysiological mapping and ablation of the heart. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute success rate of PSVT ablation using ST Catheter | Acute success rate is defined as accessory pathway/slow pathway blockade immediately after ablation, and drug and/or electrophysiological stimulation no longer induces clinical arrhythmias. | Intra-procedure |
| Incidence of primary adverse events (PAE) | Primary adverse events include device or procedure related death, myocardial infarction, atrioventricular block, thrombosis, stroke/cerebral vascular accidents (CVA), tamponade/perforation, transient ischemia attack (TIA), pericarditis, major vascular complications/bleeding, Adverse Event which prolonged hospitalization due to non-arrhythmic causes. | From procedure to pre-discharge (an average of 2-3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute success rate of cardiac ablation for AVNRT using ST catheter | defined as accessory pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation. | Intra-procedure |
| Acute success rate of cardiac ablation for AVRT using ST catheter |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications for the use of ST catheters, including:
Pregnant women
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300 patients with PSVT who meet eligibility criteria and were ablated with ST catheters will be consecutively enrolled backwards since 02 Nov 2017. Two cohorts are atrioventricular reentrant tachycardia (AVRT) and atrioventricular nodal reentrant tachycardia (AVNRT). Each of them contains at least 100 subjects.
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| Name | Affiliation | Role |
|---|---|---|
| Changsheng Ma, Professor | Beijing Anzhen Hospital | Principal Investigator |
| Haixiong Wang, Professor | Shanxi Cardiovascular Hospital | Principal Investigator |
| Shanglang Cai, Professor | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China | ||
| The Affiliated Hospital of Qingdao University |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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defined as slow pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation. |
| Intra-procedure |
| The proportion of patients who did not develop PSVT recurrence | Data can be collected from hospital medical records/database and Telephone Survey Questionnaire. Recurrence of PSVT includes recurrence of PSVT identified by electrocardiogram or other cardio-electrical equipment, re-admission due to PSVT, re-procedure due to PSVT, take anti-arrhythmic drug due to PSVT, suffering typical PSVT symptoms. | from discharge to the follow-up visit (an average of 4-6 years) |
| Incidence of serious adverse events | Data can be collected from hospital medical records/database and Telephone Survey Questionnaire. | from discharge to the follow-up visit (an average of 4-6 years) |
| Qingdao |
| Shandong |
| 266071 |
| China |
| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | 030024 | China |