An observational study in Atrioventricular Nodal Reentrant Tachycardia, sponsored by Ning Zhou. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Ning Zhou · Observational
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This study aims to evaluate the viability and therapeutic efficacy of zero-fluoroscopy radiofrequency catheter ablation (RFCA) using the superior vena cava (SVC) approach in patients with atrioventricular nodal reentrant tachycardia (AVNRT). The study compares outcomes between the SVC approach and the conventional inferior vena cava (IVC) approach. Patients diagnosed with AVNRT who underwent RFCA between June 2022 and October 2022 were retrospectively analyzed. The primary outcome measure is the non-inducibility of AVNRT, while secondary outcomes include postoperative recovery time and complication rates. The study seeks to provide a safer and more efficient RFCA method, enhancing patient recovery by minimizing radiation exposure and optimizing catheter access routes.
This retrospective study investigates the feasibility and therapeutic efficacy of zero-fluoroscopy radiofrequency catheter ablation (RFCA) using the superior vena cava (SVC) approach in patients diagnosed with atrioventricular nodal reentrant tachycardia (AVNRT). The study was conducted at our institution between June 2022 and October 2022, including adult patients (age >18 years) who underwent RFCA during this period. Patients were divided into two groups based on the catheter access site: the SVC approach group and the inferior vena cava (IVC) approach group.
The primary objective of the study is to assess the success rate of AVNRT ablation using the SVC approach compared to the conventional IVC approach, under zero-fluoroscopy conditions. Secondary objectives include evaluating the postoperative recovery time, incidence of complications, and overall patient outcomes.
Inclusion criteria required that patients experienced at least one episode of AVNRT during transesophageal atrial pacing (TEAP) and programmed stimulation. Exclusion criteria included cases where AVNRT was attributed to reversible causes such as acute myocarditis, cardiac surgery, or other types of tachycardias (e.g., atrial tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia).
The electrophysiologic study involved TEAP and programmed stimulation to screen for AVNRT and exclude other arrhythmias. The catheterization procedure was performed under conscious sedation and local infiltration anesthesia, with continuous monitoring of vital signs. Catheter access sites for the SVC group included the median cubital vein and the basilic vein, while the femoral vein was used for the IVC group. The ablation procedure utilized a large-tip electrode catheter for mapping and ablation, guided by the EnSite NavX system.
Ablation endpoints were determined by the non-inducibility of AVNRT after programmed stimulation. Follow-up evaluations included monitoring for recurrence of atrial arrhythmias or the occurrence of iatrogenic atrioventricular block (AVB). Statistical analysis was performed using R 4.4.0 software, with continuous variables expressed as mean ± SD or median (interquartile range) and categorical variables as counts or percentages. An unpaired t-test or nonparametric test was used to compare the SVC and IVC approach groups, with a p-value of \<0.05 considered statistically significant.
This study aims to demonstrate that the SVC approach for zero-fluoroscopy RFCA is a viable and effective alternative to the conventional IVC approach, potentially offering advantages such as reduced postoperative vascular events and elimination of bed rest requirements. The findings could broaden treatment options and enhance patient safety in RFCA procedures. Further research is encouraged to validate these findings across diverse populations and optimize procedural techniques for improved long-term efficacy and minimized risks.
23 studies on the registry are indexed under Tachycardia, Atrioventricular Nodal Reentry; 5 are open to participants now.
Browse Tachycardia, Atrioventricular Nodal Reentry studies →Ning Zhou is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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The study population includes adults (age >18 years) diagnosed with AVNRT who underwent RFCA at our institution between June and October 2022. Patients were divided into two groups based on catheter access site: the SVC approach group (median cubital or basilic vein) and the IVC approach group (femoral vein). Inclusion required at least one AVNRT episode during TEAP and programmed stimulation. Exclusion criteria were reversible causes of AVNRT, other tachycardias, severe comorbidities, or contraindications for conscious sedation or local anesthesia. This setup allows comparative analysis of SVC and IVC approaches focusing on success, complications, and recovery.
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Exclusion Criteria:
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 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.
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.
This group includes patients who underwent zero-fluoroscopy radiofrequency catheter ablation (RFCA) for atrioventricular nodal reentrant tachycardia (AVNRT) using the superior vena cava (SVC) approach. The catheter was inserted through the median cubital vein or basilic vein, navigating through the axillary vein, subclavian vein, and brachiocephalic vein to reach the SVC. The ablation procedure was performed under conscious sedation and local infiltration anesthesia, with a large-tip electrode catheter used for mapping and ablation guided by the EnSite NavX system. The ablation parameters were set at 40 W power and 50°C temperature.
Procedure: Zero-Fluoroscopy Radiofrequency Catheter Ablation
This group includes patients who underwent zero-fluoroscopy radiofrequency catheter ablation (RFCA) for atrioventricular nodal reentrant tachycardia (AVNRT) using the inferior vena cava (IVC) approach. The catheter was inserted through the femoral vein, extending through the iliac vein to the IVC. The ablation procedure was performed under conscious sedation and local infiltration anesthesia, with a large-tip electrode catheter used for mapping and ablation guided by the EnSite NavX system. The ablation parameters were set at 40 W power and 50°C temperature.
Patients undergo zero-fluoroscopy RFCA for atrioventricular nodal reentrant tachycardia (AVNRT) using the superior vena cava (SVC) or inferior vena cava (IVC) approach. The procedure is performed under conscious sedation and local infiltration anesthesia. A large-tip electrode catheter is used for mapping and ablation, guided by the EnSite NavX system, with ablation parameters set at 40 W power and 50°C temperature.
Non-inducibility of Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
This is determined during the procedure by performing programmed stimulation to test for the presence of AVNRT. Non-inducibility is confirmed if AVNRT cannot be induced following the ablation, indicating a successful therapeutic intervention.
Time frame: During the procedure
Recurrence of supraventricular tachycardia
It is defined as any documented episode of supraventricular tachycardia, such as AVNRT, atrial fibrillation, or atrial flutter, confirmed by electrocardiographic evidence.
Time frame: Within 1 year post-procedure
Postoperative Recovery Time
It is defined as the duration from the completion of the RFCA procedure to the patient's ability to walk unassisted.
Time frame: Within 24 hours post-procedure
Complication Rate
It is defined as any documented episode of SVT, including AVNRT, confirmed by electrocardiographic evidence.
Time frame: Within 1 year post-procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2022 to primary completion in Oct 2023, 12 months.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Tachycardia, Atrioventricular Nodal Reentry →
Ning Zhou