Atrioventricular Nodal Reentrant TachycardiaNCT06492499
Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy
An observational study of Atrioventricular Nodal Reentrant Tachycardia, run by Ning Zhou at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Nodal Reentrant Tachycardia
- What is being tested?
- Zero-Fluoroscopy Radiofrequency Catheter Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 20 Jun 2024
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy Radiofrequency Catheter Ablation for Atrioventricular Nodal Reentrant Tachycardia
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.
Read the 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 (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.
- Being tested
- Zero-Fluoroscopy Radiofrequency Catheter Ablation
- Keywords
- Zero-Fluoroscopy, Superior Vena Cava (SVC) Approach, Radiofrequency Catheter Ablation
- Medical subject headings
- Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero-Fluoroscopy Radiofrequency Catheter AblationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 1 year post-procedure
Secondary outcomes (2)
Postoperative Recovery Time
It is defined as the duration from the completion of the RFCA procedure to the patient's ability to walk unassisted.
Measured: Within 24 hours post-procedure
Complication Rate
It is defined as any documented episode of SVT, including AVNRT, confirmed by electrocardiographic evidence.
Measured: Within 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular Nodal Reentrant TachycardiaStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ning Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ning Zhou, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492499
- Sponsor's protocol ID
- m202276475
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy Radiofrequency Catheter Ablation for Atrioventricular Nodal Reentrant Tachycardia
- ClinicalTrials.gov ID
- NCT06492499
- Acronym / sponsor ID
- m202276475
- Keywords
- Zero-Fluoroscopy, Superior Vena Cava (SVC) Approach, Radiofrequency Catheter Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ning ZhouUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 9 Jul 2024 (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.
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 (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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVC Approach Group | – | Procedure: Zero-Fluoroscopy Radiofrequency Catheter AblationThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Zero-Fluoroscopy Radiofrequency Catheter AblationPatients 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. | Procedure or surgery | SVC Approach Group |
Primary outcome
Non-inducibility of Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
Time frame: During the procedure
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.
Recurrence of supraventricular tachycardia
Time frame: Within 1 year post-procedure
It is defined as any documented episode of supraventricular tachycardia, such as AVNRT, atrial fibrillation, or atrial flutter, confirmed by electrocardiographic evidence.
2 secondary outcomes
Postoperative Recovery Time
Time frame: Within 24 hours post-procedure
Complication Rate
Time frame: Within 1 year post-procedure
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 9 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrioventricular Nodal Reentrant Tachycardia, run by Ning Zhou at 1 site 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 5 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 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Non-inducibility of Atrioventricular Nodal Reentrant Tachycardia (AVNRT) (time frame: During the 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 9 Jul 2024.