Atrial ArrhythmiaZERO-FluoroNCT03458273
Real Zero Fluoroscopy Catheter Ablation.
An observational study of Atrial Arrhythmia and Ventricular Arrythmia, run by Medical University of Lublin at 3 sites in Poland.
Trial summary
A Retrospective Propensity Matched Study comparing: real zero fluoroscopy catheter ablation conventional fluoroscopy catheter ablation without 3D system conventional fluoroscopy catheter ablation with 3D system Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Atrial Arrhythmia, Ventricular Arrythmia, Arrhythmia
- What is being tested?
- Zero fluoroscopy ablation, Conventional ablation without 3D and Conventional ablation with 3D
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 3 sitesPoland
- Study dates
- 10 Mar 2018to Dec 2018
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Zero fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with 3D (Ensite/Carto) guidance but without fluoroscopy guidance Convectional fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance but without 3D (Ensite/Carto) guidance Convectional fluoroscopy group + 3D: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance and with 3D (Ensite/Carto) guidance
Who may be able to join
- right atrial tachycardia
- right atrial premature complexes
- AVNRT
- right atrial AVRT/WPW
- right ventricle tachycardia / right ventricle premature complexes
Who cannot join
- left atrium arrhythmia
- left ventricle arrhythmia
Trial locations and contacts
3 sites in 1 country.
Poland3 sites, 3 recruiting
- Recruiting
Wojewódzki Szpital Specjalistyczn
Biała Podlaska, 21-500
Maciej Wójcik, MD,PhD, +48817244151, m.wojcik@umlub.pl
- Recruiting
Medical University of Lublin
Lublin, 20-091
Maciej Wójcik, MD, PhD, +48817244151, m.wojcik@umlub.pl
- Recruiting
SP ZOZ Szpital Puławy
Puławy, 24-100
Maciej Wójcik, MD, PhD, +48817244151, m.wojcik@umlub.pl
About this study
Official title: Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study
A Retrospective Propensity Matched Study comparing:
- real zero fluoroscopy catheter ablation
- conventional fluoroscopy catheter ablation without 3D system
- conventional fluoroscopy catheter ablation with 3D system
Read the detailed description
Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias.
The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who:
- underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support
- underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support
Covariates for matching will be:
- arrhythmia type
- age of a patient
- number of diagnostic catheters used during a procedure
- type of a diagnostic catheter used during a procedure]
- Being tested
- Zero fluoroscopy ablation, Conventional ablation without 3D, Conventional ablation with 3D
- Keywords
- Atrial Arrhythmia, Ventricular Arrythmia, ablation, fluoroscopy
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero fluoroscopy ablationProcedure or surgery
Also called Zero fluoro
Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance
Conventional ablation without 3DProcedure or surgery
Also called Conventional fluoroscopy ablation without 3D
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed
Conventional ablation with 3DProcedure or surgery
Also called Conventional fluoroscopy ablation with 3D
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)
| Study group | Role | What they receive |
|---|---|---|
| Zero fluoro | Patients in whom Zero fluoroscopy ablation was performed under the guidance of Ensite for mapping and ablation and fluoroscopy will not be used during the procedure. Receives: Procedure: Zero fluoroscopy ablation | |
| Conventional ablation without 3D | Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic guidance only.
Additional use of Ensite/Carto/Localisa for mapping was not allowed. Receives: Procedure: Conventional ablation without 3D | |
| Conventional ablation with 3D | Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic and Ensite/Carto guidance and ablation during the procedure.
Use of fluoroscopy and additional Ensite/Carto for mapping and ablation was mandatory. Receives: Procedure: Conventional ablation with 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rates
arrhythmia recurrence within 3 months since the index procedure
Measured: 3 months
Secondary outcomes (7)
Total procedure time
total procedure time measured as needle to needle time
Measured: during procedure
Fluoroscopy time
total fluoroscopy time during procedure
Measured: during procedure
Acute procedural success
acute procedural success defined as arhhythia elimination
Measured: 10-30 minutes
Recurrence rate
arrhythmia recurrence within 6 months since the index procedure
Measured: 6 months
Acute Complications rate
Procedural Complications procedure
Measured: during procedure
All Complications rate
Procedural Complications and Complications within 6 months since the index procedure
Measured: 6 months
The length of stay during the hospitalization
Number of hospital days for ablation procedure from admission to discharge
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 posted8 Mar 2018
- Study start10 Mar 2018
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial ArrhythmiaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Wójcik, MD, PhD, Medical University of Lublin
- Investigators
- Maciej Wójcik, MD, PhD, Principal investigator, Medical University of Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458273
- Sponsor's protocol ID
- MW-MULublin-2
- Acronym
- ZERO-Fluoro
- Status last verified
- Sep 2018
- First submitted
- 24 Feb 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang L, Sun G, Chen X, Chen G, Yang S, Guo P, Wang Y, Wang DW. Meta-Analysis of Zero or Near-Zero Fluoroscopy Use During Ablation of Cardiac Arrhythmias. Am J Cardiol. 2016 Nov 15;118(10):1511-1518. doi: 10.1016/j.amjcard.2016.08.014. Epub 2016 Aug 24.
PubMed 27639689Casella M, Ribatti V, Catto V, Vettor G, Fassini G, Biagioli V, Dello Russo A, Tondo C. Benefits of electroanatomic ablation of conventional cardiac arrhytmias: from fluoroscopy to zero X-ray mapping. Minerva Cardioangiol. 2018 Feb;66(1):49-62. doi: 10.23736/S0026-4725.17.04478-4. Epub 2017 Aug 31.
PubMed 28862408Gaita F, Guerra PG, Battaglia A, Anselmino M. The dream of near-zero X-rays ablation comes true. Eur Heart J. 2016 Sep 21;37(36):2749-2755. doi: 10.1093/eurheartj/ehw223. Epub 2016 Jun 26.
PubMed 27354053Seizer P, Bucher V, Frische C, Heinzmann D, Gramlich M, Muller I, Henning A, Hofbeck M, Kerst G, Gawaz M, Schreieck J. Efficacy and safety of zero-fluoroscopy ablation for supraventricular tachycardias. Use of optional contact force measurement for zero-fluoroscopy ablation in a clinical routine setting. Herz. 2016 May;41(3):241-5. doi: 10.1007/s00059-015-4358-4. Epub 2015 Oct 13.
PubMed 26462477Bulava A, Hanis J, Eisenberger M. Catheter Ablation of Atrial Fibrillation Using Zero-Fluoroscopy Technique: A Randomized Trial. Pacing Clin Electrophysiol. 2015 Jul;38(7):797-806. doi: 10.1111/pace.12634. Epub 2015 Apr 16.
PubMed 25790320Scaglione M, Ebrille E, Clemente FD, Gaita F, Bradfield JS. Catheter Ablation of Atrial Fibrillation Without Radiation Exposure Using A 3D Mapping System. J Atr Fibrillation. 2015 Feb 28;7(5):1167. doi: 10.4022/jafib.1167. eCollection 2015 Feb-Mar.
PubMed 27957146Alvarez M, Bertomeu-Gonzalez V, Arcocha MF, Morina P, Tercedor L, Ferrero de Loma A, Pachon M, Garcia A, Pardo M, Datino T, Alonso C, Osca J; investigators of the Spanish Multicenter Registry of Fluoroscopy-free Ablation. Nonfluoroscopic Catheter Ablation. Results From a Prospective Multicenter Registry. Rev Esp Cardiol (Engl Ed). 2017 Sep;70(9):699-705. doi: 10.1016/j.rec.2016.12.040. Epub 2017 Jan 31. English, Spanish.
PubMed 28159569
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study
- ClinicalTrials.gov ID
- NCT03458273
- Acronym / sponsor ID
- ZERO-Fluoro / MW-MULublin-2
- Keywords
- Atrial Arrhythmia, Ventricular Arrythmia, ablation, fluoroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Mar 2018 (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.
A Retrospective Propensity Matched Study comparing:
- real zero fluoroscopy catheter ablation
- conventional fluoroscopy catheter ablation without 3D system
- conventional fluoroscopy catheter ablation with 3D system
Detailed description
Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias.
The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who:
- underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support
- underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support
Covariates for matching will be:
- arrhythmia type
- age of a patient
- number of diagnostic catheters used during a procedure
- type of a diagnostic catheter used during a procedure]
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zero fluoro | – | Procedure: Zero fluoroscopy ablationPatients in whom Zero fluoroscopy ablation was performed under the guidance of Ensite for mapping and ablation and fluoroscopy will not be used during the procedure. |
| Conventional ablation without 3D | – | Procedure: Conventional ablation without 3DPatients in whom Conventional fluoroscopy ablation was performed under fluoroscopic guidance only. Additional use of Ensite/Carto/Localisa for mapping was not allowed. |
| Conventional ablation with 3D | – | Procedure: Conventional ablation with 3DPatients in whom Conventional fluoroscopy ablation was performed under fluoroscopic and Ensite/Carto guidance and ablation during the procedure. Use of fluoroscopy and additional Ensite/Carto for mapping and ablation was mandatory. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Zero fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with 3D (Ensite/Carto) guidance but without fluoroscopy guidance Convectional fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance but without 3D (Ensite/Carto) guidance Convectional fluoroscopy group + 3D: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance and with 3D (Ensite/Carto) guidance
Key inclusion criteria (5 listed)
- right atrial tachycardia
- right atrial premature complexes
- AVNRT
- right atrial AVRT/WPW
- right ventricle tachycardia / right ventricle premature complexes
Key exclusion criteria (2 listed)
- left atrium arrhythmia
- left ventricle arrhythmia
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 ablationAlso: Zero fluoroCatheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance | Procedure or surgery | Zero fluoro |
| Conventional ablation without 3DAlso: Conventional fluoroscopy ablation without 3DCatheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed | Procedure or surgery | Conventional ablation without 3D |
| Conventional ablation with 3DAlso: Conventional fluoroscopy ablation with 3DCatheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto) | Procedure or surgery | Conventional ablation with 3D |
Primary outcome
Procedural success rates
Time frame: 3 months
arrhythmia recurrence within 3 months since the index procedure
7 secondary outcomes
Total procedure time
Time frame: during procedure
Fluoroscopy time
Time frame: during procedure
Acute procedural success
Time frame: 10-30 minutes
Recurrence rate
Time frame: 6 months
Acute Complications rate
Time frame: during procedure
All Complications rate
Time frame: 6 months
The length of stay during the hospitalization
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Background: PubMed 27639689Yang L, Sun G, Chen X, Chen G, Yang S, Guo P, Wang Y, Wang DW. Meta-Analysis of Zero or Near-Zero Fluoroscopy Use During Ablation of Cardiac Arrhythmias. Am J Cardiol. 2016 Nov 15;118(10):1511-1518. doi: 10.1016/j.amjcard.2016.08.014. Epub 2016 Aug 24.
- Background: PubMed 28862408Casella M, Ribatti V, Catto V, Vettor G, Fassini G, Biagioli V, Dello Russo A, Tondo C. Benefits of electroanatomic ablation of conventional cardiac arrhytmias: from fluoroscopy to zero X-ray mapping. Minerva Cardioangiol. 2018 Feb;66(1):49-62. doi: 10.23736/S0026-4725.17.04478-4. Epub 2017 Aug 31.
- Background: PubMed 27354053Gaita F, Guerra PG, Battaglia A, Anselmino M. The dream of near-zero X-rays ablation comes true. Eur Heart J. 2016 Sep 21;37(36):2749-2755. doi: 10.1093/eurheartj/ehw223. Epub 2016 Jun 26.
- Background: PubMed 26462477Seizer P, Bucher V, Frische C, Heinzmann D, Gramlich M, Muller I, Henning A, Hofbeck M, Kerst G, Gawaz M, Schreieck J. Efficacy and safety of zero-fluoroscopy ablation for supraventricular tachycardias. Use of optional contact force measurement for zero-fluoroscopy ablation in a clinical routine setting. Herz. 2016 May;41(3):241-5. doi: 10.1007/s00059-015-4358-4. Epub 2015 Oct 13.
- Background: PubMed 25790320Bulava A, Hanis J, Eisenberger M. Catheter Ablation of Atrial Fibrillation Using Zero-Fluoroscopy Technique: A Randomized Trial. Pacing Clin Electrophysiol. 2015 Jul;38(7):797-806. doi: 10.1111/pace.12634. Epub 2015 Apr 16.
- Background: PubMed 27957146Scaglione M, Ebrille E, Clemente FD, Gaita F, Bradfield JS. Catheter Ablation of Atrial Fibrillation Without Radiation Exposure Using A 3D Mapping System. J Atr Fibrillation. 2015 Feb 28;7(5):1167. doi: 10.4022/jafib.1167. eCollection 2015 Feb-Mar.
- Results publication: PubMed 28159569Alvarez M, Bertomeu-Gonzalez V, Arcocha MF, Morina P, Tercedor L, Ferrero de Loma A, Pachon M, Garcia A, Pardo M, Datino T, Alonso C, Osca J; investigators of the Spanish Multicenter Registry of Fluoroscopy-free Ablation. Nonfluoroscopic Catheter Ablation. Results From a Prospective Multicenter Registry. Rev Esp Cardiol (Engl Ed). 2017 Sep;70(9):699-705. doi: 10.1016/j.rec.2016.12.040. Epub 2017 Jan 31. English, Spanish.
- Individual participant dataSharing planned: Undecided
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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.
Maciej Wójcik, MD, PhD principal investigator
Medical University of Lublin, Poland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Arrhythmia and Ventricular Arrythmia, run by Medical University of Lublin at 3 sites in Poland.
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 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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 Maciej Wójcik, MD, PhD (+48817244151, m.wojcik@umlub.pl), 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 NCT03458273, which also lists 7 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 10 Sep 2018.