Paroxysmal Supraventricular TachycardiaNCT03348436
Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation
A study testing radiofrequency ablation in people with Paroxysmal Supraventricular Tachycardia, run by Ruiqin xie at 1 site in China.
Trial summary
This study to investigate the effects of RF ablation on left atrial systolic function in patients with atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular tachycardia (AVRT). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Mar 2020
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with paroxysmal supraventricular tachycardia,includes atrioventricular reentrant tachycardia and atrioventricular nodal reentrant tachycardia， Age is >14 years
Who cannot join
- Atrial fibrillation, Atrial tachycardia， Structural heart disease, Ventricular arrhythmias, Patients with impaired left ventricular systolic function or on antiarrhythmics
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
This study to investigate the effects of RF ablation on left atrial systolic function in patients with atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular tachycardia (AVRT).
Read the detailed description
A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation. Left atrial systolic function was assessed using atrial ejection force (AEF) according to Manning's formula (AEF = 0.5 x ρ x MA x A(2), r: blood density = 1.06 g/cm(3), MA: mitral orifice area [cm(2)], A: A wave velocity). The following left atrial dimensions were assessed: antero-posterior (LA-AP), infero-superior (LA-IS, long axis), medio-lateral (LA-ML, short axis). The correlations between AEF and electrophysiological parameters were analysed (VA - ventriculo-atrial conduction, VA/CL - tachycardia cycle length).
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Being tested
- radiofrequency ablation
- Keywords
- paroxysmal supraventricular tachycardia, Left Atrial Function
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patients with atrioventricular nodal reentrant tachycardia | Experimental | radiofrequency catheter ablation therapy Receives: Procedure: radiofrequency ablation |
| patients with atrioventricular tachycardia | Experimental | radiofrequency catheter ablation therapy Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Atrial Function of postoperative radiofrequency ablation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jan 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Supraventricular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruiqin xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruiqin xie, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348436
- Sponsor's protocol ID
- xierqdoctorSVT
- Status last verified
- Mar 2020
- First submitted
- 16 Nov 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT03348436
- Acronym / sponsor ID
- xierqdoctorSVT
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Keywords
- paroxysmal supraventricular tachycardia, Left Atrial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ruiqin xieUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 20 Nov 2017 (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 to investigate the effects of RF ablation on left atrial systolic function in patients with atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular tachycardia (AVRT).
Detailed description
A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation. Left atrial systolic function was assessed using atrial ejection force (AEF) according to Manning's formula (AEF = 0.5 x ρ x MA x A(2), r: blood density = 1.06 g/cm(3), MA: mitral orifice area [cm(2)], A: A wave velocity). The following left atrial dimensions were assessed: antero-posterior (LA-AP), infero-superior (LA-IS, long axis), medio-lateral (LA-ML, short axis). The correlations between AEF and electrophysiological parameters were analysed (VA - ventriculo-atrial conduction, VA/CL - tachycardia cycle length).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation.
| Arm | Type | Receives |
|---|---|---|
| patients with atrioventricular nodal reentrant tachycardia | Experimental | Procedure: radiofrequency ablationradiofrequency catheter ablation therapy |
| patients with atrioventricular tachycardia | Experimental | Procedure: radiofrequency ablationradiofrequency catheter ablation therapy |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with paroxysmal supraventricular tachycardia,includes atrioventricular reentrant tachycardia and atrioventricular nodal reentrant tachycardia， Age is >14 years
Key exclusion criteria (1 listed)
- Atrial fibrillation, Atrial tachycardia， Structural heart disease, Ventricular arrhythmias, Patients with impaired left ventricular systolic function or on antiarrhythmics
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 |
|---|---|---|
| radiofrequency ablation | Procedure or surgery | patients with atrioventricular nodal reentrant tachycardia, patients with atrioventricular tachycardia |
Primary outcome
Left Atrial Function of postoperative radiofrequency ablation.
Time frame: 1 month
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 18 Mar 2020.
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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?
A study testing radiofrequency ablation in people with Paroxysmal Supraventricular Tachycardia, run by Ruiqin xie 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 1 inclusion and 1 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 18 Mar 2020. 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?
Left Atrial Function of postoperative radiofrequency ablation. (time frame: 1 month). 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 18 Mar 2020.