Ventricular ArrythmiaZFOVANCT03041519
Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias
A study testing Zero-fluoroscopy ablation and Conventional fluoroscopy ablation in people with Ventricular Arrythmia and Ventricular Premature Complexes, run by Tongji Hospital at 1 site in China.
Trial summary
This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Arrythmia, Ventricular Premature Complexes, Ventricular Tachycardia
- What is being tested?
- Zero-fluoroscopy ablation and Conventional fluoroscopy ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ventricular Tachycardia
- Ventricular Premature Complexes
Who cannot join
- Organic ventricular tachycardia or ventricular premature complexes
- Drug-induced ventricular tachycardia or ventricular premature complexes
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yan Wang, PhD, +86-13697326307, newswangyan@126.com
Guangzhi Chen, PhD, 86-27-83662842, chengz2003@163.com
About this study
Official title: Multi-center, Randomized, Controlled, Prospective Trial to Compare the Feasibility, Safety, and Efficacy of Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias.
This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
Read the detailed description
Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
- Being tested
- Zero-fluoroscopy ablation, Conventional fluoroscopy ablation
- Keywords
- Fluoroscopy, Ablation, Three dimensional, Ventricular arrhythmias, Radiation
- Medical subject headings
- Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero-fluoroscopy ablationProcedure or surgery
Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
Conventional fluoroscopy ablationProcedure or surgery
Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.
| Study group | Role | What they receive |
|---|---|---|
| Zero-fluoroscopy ablation | Experimental | Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure. Receives: Procedure: Zero-fluoroscopy ablation |
| Conventional fluoroscopy ablation | Active comparator | Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure. Receives: Procedure: Conventional fluoroscopy ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rates
Measured: 3 months
Secondary outcomes (4)
Total procedure time
Measured: during procedure
Fluoroscopy time
Measured: during procedure
Complications
Measured: 1 year
Immediate success rate
Measured: 10~30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startOct 2011
- Primary completionJul 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrythmiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, Xinyang Central Hospital, Ningbo No. 1 Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Guangxi Medical University
- Responsible party
- Principal investigator, Yan Wang, Tongji Hospital
- Investigators
- Yan Wang, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041519
- Sponsor's protocol ID
- TJHXXG-ZF-VT-20161220
- Acronym
- ZFOVA
- Status last verified
- Jan 2017
- First submitted
- 29 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Andrade JG, Rivard L, Macle L. The past, the present, and the future of cardiac arrhythmia ablation. Can J Cardiol. 2014 Dec;30(12 Suppl):S431-41. doi: 10.1016/j.cjca.2014.07.731. Epub 2014 Jul 24.
PubMed 25432138Anselmino 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 22526222Kozluk E, Gawrysiak M, Piatkowska A, Lodzinski P, Kiliszek M, Malkowska S, Zaczek R, Piatkowski R, Opolski G, Kozlowski D. Radiofrequency ablation without the use of fluoroscopy - in what kind of patients is it feasible? Arch Med Sci. 2013 Oct 31;9(5):821-5. doi: 10.5114/aoms.2013.38676. Epub 2013 Nov 5.
PubMed 24273563
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Controlled, Prospective Trial to Compare the Feasibility, Safety, and Efficacy of Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias.
- ClinicalTrials.gov ID
- NCT03041519
- Acronym / sponsor ID
- ZFOVA / TJHXXG-ZF-VT-20161220
- Keywords
- Fluoroscopy, Ablation, Three dimensional, Ventricular arrhythmias, Radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, Xinyang Central Hospital, Ningbo No. 1 Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Guangxi Medical University
- Study start
- Oct 2011
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 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 intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
Detailed description
Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero-fluoroscopy ablation | Experimental | Procedure: Zero-fluoroscopy ablationZero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure. |
| Conventional fluoroscopy ablation | Active comparator | Procedure: Conventional fluoroscopy ablationConventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ventricular Tachycardia
- Ventricular Premature Complexes
Key exclusion criteria (2 listed)
- Organic ventricular tachycardia or ventricular premature complexes
- Drug-induced ventricular tachycardia or ventricular premature complexes
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 ablationCatheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy. | Procedure or surgery | Zero-fluoroscopy ablation |
| Conventional fluoroscopy ablationCatheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX. | Procedure or surgery | Conventional fluoroscopy ablation |
Primary outcome
Procedural success rates
Time frame: 3 months
4 secondary outcomes
Total procedure time
Time frame: during procedure
Fluoroscopy time
Time frame: during procedure
Complications
Time frame: 1 year
Immediate success rate
Time frame: 10~30minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Background: PubMed 25432138Andrade JG, Rivard L, Macle L. The past, the present, and the future of cardiac arrhythmia ablation. Can J Cardiol. 2014 Dec;30(12 Suppl):S431-41. doi: 10.1016/j.cjca.2014.07.731. Epub 2014 Jul 24.
- 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 24273563Kozluk E, Gawrysiak M, Piatkowska A, Lodzinski P, Kiliszek M, Malkowska S, Zaczek R, Piatkowski R, Opolski G, Kozlowski D. Radiofrequency ablation without the use of fluoroscopy - in what kind of patients is it feasible? Arch Med Sci. 2013 Oct 31;9(5):821-5. doi: 10.5114/aoms.2013.38676. Epub 2013 Nov 5.
- 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
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-fluoroscopy ablation and Conventional fluoroscopy ablation in people with Ventricular Arrythmia and Ventricular Premature Complexes, 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: status not confirmed, as of the sponsor's last update on 2 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, PhD (86-27-83663280, newswangyan@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rates (time frame: 3 months). 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 NCT03041519, which also lists 3 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 2 Feb 2017.