AVRT, AVNRTST in PSVT-RWSNCT04923815
A Real-world Study of Cardiac Ablation for PSVT Using ST Catheter
An observational study of AVRT, AVNRT, run by Johnson & Johnson Medical (Shanghai) Ltd. at 3 sites in China.
Trial summary
Paroxysmal supraventricular tachycardia known as PSVT includes atrioventricular reentrant tachycardia (AVRT) and atrioventricular nodal reentrant tachycardia (AVNRT). This study is multicenter, retrospective, cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AVRT, AVNRT
- What is being tested?
- THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 20 Jul 2021to 14 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Waiver of informed consent is approved by Ethics Committee, or follow methods approved by Ethics Committee to get patient's informed consent (such as get informed consent by telephone contact, etc.).
- Patients diagnosed as atrioventricular reentrant tachycardia (AVRT), atrioventricular node reentrant tachycardia (AVNRT) after surgery/discharge, and the existing source records must include 1) at least 1 copy of preoperative ECG or intraoperative electrophysiological examination results;2) Information about the acute procedure outcome.
- Patients were ablated by ST catheter.
- Adult patients 18 years or older.
Who cannot join
- Contraindications for the use of ST catheters, including:
- Ventriculotomy or atriotomy was performed within 8 weeks before the procedure;
- Presence of myxoma or intracardiac thrombus;
- fitted with artificial valves;
- Active systemic infection;
- Atrial septal patch.
- Pregnant women
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Anzhen hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024
About this study
Official title: A Real-world Study of Cardiac Ablation for Paroxysmal Supraventricular Tachycardia Using THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter（ST in PSVT-RWS）
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）
- Conditions
- AVRT, AVNRT
- Being tested
- THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter
- Keywords
- AVRT, AVNRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AVNRT | atrioventricular nodal reentrant tachycardia Receives: Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter | |
| AVRT | atrioventricular reentrant tachycardia, including Wolff-Parkinson-White syndrome（WPW） Receives: Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From procedure to pre-discharge (an average of 2-3 days)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from discharge to the follow-up visit (an average of 4-6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start20 Jul 2021
- Primary completion3 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AVRT, AVNRTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changsheng Ma, Professor, Principal investigator, Beijing Anzhen HospitalHaixiong Wang, Professor, Principal investigator, Shanxi Cardiovascular HospitalShanglang Cai, Professor, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923815
- Sponsor's protocol ID
- BWI_2020_01
- Acronym
- ST in PSVT-RWS
- Status last verified
- Feb 2022
- First submitted
- 29 Apr 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Cardiac Ablation for Paroxysmal Supraventricular Tachycardia Using THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter（ST in PSVT-RWS）
- ClinicalTrials.gov ID
- NCT04923815
- Acronym / sponsor ID
- ST in PSVT-RWS / BWI_2020_01
- Conditions
- AVRT, AVNRT
- Keywords
- AVRT, AVNRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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）
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVNRT | – | Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheteratrioventricular nodal reentrant tachycardia |
| AVRT | – | Device: THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheteratrioventricular reentrant tachycardia, including Wolff-Parkinson-White syndrome（WPW） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Waiver of informed consent is approved by Ethics Committee, or follow methods approved by Ethics Committee to get patient's informed consent (such as get informed consent by telephone contact, etc.).
- Patients diagnosed as atrioventricular reentrant tachycardia (AVRT), atrioventricular node reentrant tachycardia (AVNRT) after surgery/discharge, and the existing source records must include 1) at least 1 copy of preoperative ECG or intraoperative electrophysiological examination results;2) Information about the acute procedure outcome.
- Patients were ablated by ST catheter.
- Adult patients 18 years or older.
Key exclusion criteria (7 listed)
- Contraindications for the use of ST catheters, including:
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip CatheterTHERMOCOOL 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. | Device | AVNRT, AVRT |
Primary outcome
Acute success rate of PSVT ablation using ST Catheter
Time frame: Intra-procedure
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.
Incidence of primary adverse events (PAE)
Time frame: From procedure to pre-discharge (an average of 2-3 days)
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.
4 secondary outcomes
Acute success rate of cardiac ablation for AVNRT using ST catheter
Time frame: Intra-procedure
Acute success rate of cardiac ablation for AVRT using ST catheter
Time frame: Intra-procedure
The proportion of patients who did not develop PSVT recurrence
Time frame: from discharge to the follow-up visit (an average of 4-6 years)
Incidence of serious adverse events
Time frame: from discharge to the follow-up visit (an average of 4-6 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changsheng Ma, Professor principal investigator
Beijing Anzhen Hospital
Haixiong Wang, Professor principal investigator
Shanxi Cardiovascular Hospital
Shanglang Cai, Professor principal investigator
The Affiliated Hospital of Qingdao University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AVRT, AVNRT, run by Johnson & Johnson Medical (Shanghai) Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute success rate of PSVT ablation using ST Catheter (time frame: Intra-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.