Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy

NCT06492499 | Completed

• 1 other identifier: m202276475
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrioventricular Nodal Reentrant Tachycardia

Keywords

Zero-Fluoroscopy; Superior Vena Cava (SVC) Approach; Radiofrequency Catheter Ablation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 1 year post-procedure

Secondary Outcomes (2)

• Postoperative Recovery Time

  Within 24 hours post-procedure

• Complication Rate

  Within 1 year post-procedure

Study Arms (2)

SVC Approach Group

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

IVC Approach Group

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.

Interventions

Zero-Fluoroscopy Radiofrequency Catheter Ablation PROCEDURE

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.

SVC Approach Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adults aged \>18 years.
• Diagnosed with atrioventricular nodal reentrant tachycardia (AVNRT).
• Underwent radiofrequency catheter ablation (RFCA) at our institution between June 2022 and October 2022.
• Experienced at least one episode of AVNRT during transesophageal atrial pacing (TEAP) and programmed stimulation.
• Provided informed consent for the procedure and data collection.

You may not qualify if:

• AVNRT attributed to reversible causes, such as acute myocarditis or recent cardiac surgery.
• Presence of other types of tachycardias (e.g., atrial tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia).
• Inability to abstain from pharmacological interventions for at least five half-lives of the medication prior to TEAP.
• Contraindications for the use of conscious sedation or local anesthesia.
• Severe comorbidities that would interfere with study participation or follow-up.
• Patients who are pregnant or lactating.
• Previous RFCA procedures for AVNRT within the past six months.

Sponsors & Collaborators

• Ning Zhou: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia, Reciprocating; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 9, 2024
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: June 20, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)