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Completed

NCT Number: NCT04923815

A Real-world Study of Cardiac Ablation for PSVT Using ST Catheter

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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Key information

Conditions

AVRT, AVNRT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Acute success rate of cardiac ablation for AVNRT using ST catheter

    Time frame: Intra-procedure

    defined as accessory pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation.

  2. Acute success rate of cardiac ablation for AVRT using ST catheter

    Time frame: Intra-procedure

    defined as slow pathway blockade, and clinical arrhythmia could not be induced by drug and/or stimulation.

  3. 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)

    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.

  4. Incidence of serious adverse events

    Time frame: from discharge to the follow-up visit (an average of 4-6 years)

    Data can be collected from hospital medical records/database and Telephone Survey Questionnaire.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Medical (Shanghai) Ltd.

Industry

Registry information

Official study title

A Real-world Study of Cardiac Ablation for Paroxysmal Supraventricular Tachycardia Using THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter（ST in PSVT-RWS）

Acronym: ST in PSVT-RWS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2021
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.