An observational study in AVRT, AVNRT, sponsored by Johnson & Johnson Medical (Shanghai) Ltd.. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by Johnson & Johnson Medical (Shanghai) Ltd. (part of Johnson & Johnson) · Observational
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）
Johnson & Johnson Medical (Shanghai) Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
for the use of ST catheters, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
atrioventricular nodal reentrant tachycardia
Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter
atrioventricular reentrant tachycardia, including Wolff-Parkinson-White syndrome（WPW）
Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter
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.
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.
Time frame: 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.
Time frame: From procedure to pre-discharge (an average of 2-3 days)
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.
Time frame: Intra-procedure
Acute success rate of cardiac ablation for AVRT using ST catheter
defined as slow pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation.
Time frame: 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.
Time frame: 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.
Time frame: from discharge to the follow-up visit (an average of 4-6 years)
Plan to share: Yes — 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.
Data sharing details ↗ · yoda.yale.edu.
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Dec 2021, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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