Paroxysmal Supraventricular TachycardiaZFA-PSVTNCT03042078
Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
A study testing Zero-fluoroscopic ablation and Conventional fluoroscopic ablation in people with Paroxysmal Supraventricular Tachycardia, run by Tongji Hospital at 1 site in China.
Trial summary
This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia
- What is being tested?
- Zero-fluoroscopic ablation and Conventional fluoroscopic ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,060 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2018
- 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 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Atrioventricular Nodal Reentrant Tachycardia
- Atrioventricular Reentrant Tachycardia
Who cannot join
- Atrial Tachycardia
- Organic supraventricular tachycardia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
Read the detailed description
Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Being tested
- Zero-fluoroscopic ablation, Conventional fluoroscopic ablation
- Keywords
- Fluoroscopy, Ablation, Three dimensional, Paroxysmal supraventricular tachycardia, Radiation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero-fluoroscopic ablationDevice
Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.
Conventional fluoroscopic ablationDevice
Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Zero-fluoroscopic ablation | Experimental | Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy. Receives: Device: Zero-fluoroscopic ablation |
| Conventional fluoroscopic ablation | Active comparator | Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy. Receives: Device: Conventional fluoroscopic ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate
Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine.
Measured: one year
Secondary outcomes (5)
Complications
Complications were defined as pseudoaneurysm, arterialvenous fistula, pneumothorax, second- or third-degree atrioventricular block, cardiac tamponade, or other serious complications requiring intervention.
Measured: one year
Immediate success rate
Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine.
Measured: one day
Recurrence Rate
- An ECG and electrophysiology study would be performed to rule out recurrence when the patients had suspicious symptoms or signs.
Measured: 1 year
Total procedure time
Procedure time (in minutes) was defined as the interval from the beginning of local anesthesia to extraction of all femoral venous sheaths at the end of the procedure. Total ablation time was calculated in seconds but time for tentative ablation was not taken into account.
Measured: one day
Fluoroscopy time
- Fluoroscopy time (in minutes) was defined as thetotal duration of exposure during the procedure.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startJan 2012
- Primary completionFeb 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Supraventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital, Sun Yat-Sen University, Xiangyang Central Hospital, First Affiliated Hospital of Guangxi Medical University, Guangdong Provincial People's Hospital, Morristown Memorial Hospital, Beijing Anzhen Hospital, Ningbo No. 1 Hospital
- Responsible party
- Principal investigator, Yan Wang, Tongji Hospital
- Investigators
- Yan Wang, PhD, Principal investigator, Tongji Hospital Wuhan, Hubei China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042078
- Sponsor's protocol ID
- TJHCDD-ZF-PSVT-20140301
- Acronym
- ZFA-PSVT
- Status last verified
- Nov 2023
- First submitted
- 27 Jan 2017
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555.
PubMed 22526222Mobinizadeh M, Arabloo J, Hamouzadeh P, Akbari Sari A. A systematic review of the effectiveness of catheter ablation NavX mapping system for treatment of the cardiac arrhythmia. Med J Islam Repub Iran. 2015 Mar 10;29:189. eCollection 2015.
PubMed 26034742Wang Y, Patel D, Wang DW, Yan JT, Hsia HH, Liu H, Zhao CX, Zuo HJ, Wang DW. beta1-Adrenoceptor blocker aggravated ventricular arrhythmia. Pacing Clin Electrophysiol. 2013 Nov;36(11):1348-56. doi: 10.1111/pace.12196. Epub 2013 Jun 10.
PubMed 23750689Lim PB, Robb D, Lambiase PD. Electrophysiology and ablation of arrhythmias. Br J Hosp Med (Lond). 2012 Jun;73(6):312-8. doi: 10.12968/hmed.2012.73.6.312.
PubMed 22875320Brown KR, Rzucidlo E. Acute and chronic radiation injury. J Vasc Surg. 2011 Jan;53(1 Suppl):15S-21S. doi: 10.1016/j.jvs.2010.06.175. Epub 2010 Sep 16.
PubMed 20843630Chen G, Wang Y, Proietti R, Wang X, Ouyang F, Ma CS, Yu RH, Zhao C, Ma K, Qiu J, Liu Q, Wang DW. Zero-fluoroscopy approach for ablation of supraventricular tachycardia using the Ensite NavX system: a multicenter experience. BMC Cardiovasc Disord. 2020 Feb 3;20(1):48. doi: 10.1186/s12872-020-01344-0.
PubMed 32013865
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT03042078
- Acronym / sponsor ID
- ZFA-PSVT / TJHCDD-ZF-PSVT-20140301
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Keywords
- Fluoroscopy, Ablation, Three dimensional, Paroxysmal supraventricular tachycardia, Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,060 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital, Sun Yat-Sen University, Xiangyang Central Hospital, First Affiliated Hospital of Guangxi Medical University, Guangdong Provincial People's Hospital, Morristown Memorial Hospital, Beijing Anzhen Hospital, Ningbo No. 1 Hospital
- Study start
- Jan 2012
- Primary completion
- Feb 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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 is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
Detailed description
Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero-fluoroscopic ablation | Experimental | Device: Zero-fluoroscopic ablationParoxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy. |
| Conventional fluoroscopic ablation | Active comparator | Device: Conventional fluoroscopic ablationParoxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy. |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Atrioventricular Nodal Reentrant Tachycardia
- Atrioventricular Reentrant Tachycardia
Key exclusion criteria (2 listed)
- Atrial Tachycardia
- Organic supraventricular tachycardia
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-fluoroscopic ablationCatheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy. | Device | Zero-fluoroscopic ablation |
| Conventional fluoroscopic ablationCatheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy. | Device | Conventional fluoroscopic ablation |
Primary outcome
Procedural success rate
Time frame: one year
Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine.
5 secondary outcomes
Complications
Time frame: one year
Immediate success rate
Time frame: one day
Recurrence Rate
Time frame: 1 year
Total procedure time
Time frame: one day
Fluoroscopy time
Time frame: one day
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 24 Nov 2023.
- Background: PubMed 22526222Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555.
- Background: PubMed 26034742Mobinizadeh M, Arabloo J, Hamouzadeh P, Akbari Sari A. A systematic review of the effectiveness of catheter ablation NavX mapping system for treatment of the cardiac arrhythmia. Med J Islam Repub Iran. 2015 Mar 10;29:189. eCollection 2015.
- Background: PubMed 23750689Wang Y, Patel D, Wang DW, Yan JT, Hsia HH, Liu H, Zhao CX, Zuo HJ, Wang DW. beta1-Adrenoceptor blocker aggravated ventricular arrhythmia. Pacing Clin Electrophysiol. 2013 Nov;36(11):1348-56. doi: 10.1111/pace.12196. Epub 2013 Jun 10.
- Background: PubMed 22875320Lim PB, Robb D, Lambiase PD. Electrophysiology and ablation of arrhythmias. Br J Hosp Med (Lond). 2012 Jun;73(6):312-8. doi: 10.12968/hmed.2012.73.6.312.
- Background: PubMed 20843630Brown KR, Rzucidlo E. Acute and chronic radiation injury. J Vasc Surg. 2011 Jan;53(1 Suppl):15S-21S. doi: 10.1016/j.jvs.2010.06.175. Epub 2010 Sep 16.
- Derived from this study: PubMed 32013865Chen G, Wang Y, Proietti R, Wang X, Ouyang F, Ma CS, Yu RH, Zhao C, Ma K, Qiu J, Liu Q, Wang DW. Zero-fluoroscopy approach for ablation of supraventricular tachycardia using the Ensite NavX system: a multicenter experience. BMC Cardiovasc Disord. 2020 Feb 3;20(1):48. doi: 10.1186/s12872-020-01344-0.
- 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.
Yan Wang, PhD principal investigator
Tongji Hospital Wuhan, Hubei China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zero-fluoroscopic ablation and Conventional fluoroscopic ablation in people with Paroxysmal Supraventricular Tachycardia, run by Tongji Hospital 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 2 inclusion and 2 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 24 Nov 2023. 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?
Procedural success rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042078, which also lists 6 linked publications.
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 24 Nov 2023.