Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492499
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-07-02
Brief Title:
Patient-Centric Innovation Superior Vena Cava Approach in Zero-Fluoroscopy
Sponsor:
Ning Zhou
Organization:
Tongji Hospital
Study Overview
Official Title:
Patient-Centric Innovation Superior Vena Cava Approach in Zero-Fluoroscopy Radiofrequency Catheter Ablation for Atrioventricular Nodal Reentrant Tachycardia
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 eg 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 440 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 005 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
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 eg 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 440 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None