Atrial FibrillationAF-FIINCT02137798
Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation
A study testing Radio-frequency catheter ablation in people with Atrial Fibrillation, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radio-frequency catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Sep 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented atrial fibrillation in the 12-lead ECG or Holter ECG
- Paroxysmal symptomatic atrial fibrillation
- Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
- Age 18-75 years
- left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )
- A signed consent form
Who cannot join
- Reversible etiology of atrial fibrillation
- Pregnancy
- Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
- Intracardiac thrombus
- Contraindication to anticoagulation
- Thromboembolic event in the last 6 months
- Previous left atrial ablation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Electrophysiology, University of Dresden - Heart Center
Dresden, Saxony, 01307
About this study
Official title: Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System
To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration
Read the detailed description
The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.
The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.
The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.
- Conditions
- Atrial Fibrillation
- Being tested
- Radio-frequency catheter ablation
- Keywords
- fluoroscopy exposure, paroxysmal atrial fibrillation Ablation, fluoroscopy, Atrial Fibrillation Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-frequency catheter ablationDevice
Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
| Study group | Role | What they receive |
|---|---|---|
| CARTOUNIVU | Experimental | Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system Receives: Device: Radio-frequency catheter ablation |
| CARTO3 | Active comparator | Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique Receives: Device: Radio-frequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoroscopy time for each step of atrial fibrillation ablation procedure
Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
Measured: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Fluoroscopy doses for each step of atrial fibrillation ablation procedure
Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
Measured: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Secondary outcomes (3)
Number of patients with adverse events as a measure of safety
Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc.
Measured: All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy
number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation
Measured: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Total time of atrial fibrillation ablation procedure as a measure of efficacy
procedure time (minute)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Christopher Piorkowski, Technische Universität Dresden
- Investigators
- Christopher Piorkowski, M.D., Principal investigator, Department of Electrophysiology, University of Dresden - Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137798
- Sponsor's protocol ID
- EK474122013
- Other IDs
- CARTOUNIVU
- Acronym
- AF-FII
- Status last verified
- Oct 2014
- First submitted
- 2 May 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System
- ClinicalTrials.gov ID
- NCT02137798
- Acronym / sponsor ID
- AF-FII / EK474122013
- Conditions
- Atrial Fibrillation
- Keywords
- fluoroscopy exposure, paroxysmal atrial fibrillation Ablation, fluoroscopy, Atrial Fibrillation Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 May 2014 (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.
To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration
Detailed description
The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.
The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.
The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARTOUNIVU | Experimental | Device: Radio-frequency catheter ablationRadiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system |
| CARTO3 | Active comparator | Device: Radio-frequency catheter ablationRadiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- documented atrial fibrillation in the 12-lead ECG or Holter ECG
- Paroxysmal symptomatic atrial fibrillation
- Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
- Age 18-75 years
- left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )
Key exclusion criteria (7 listed)
- Reversible etiology of atrial fibrillation
- Pregnancy
- Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
- Intracardiac thrombus
- Contraindication to anticoagulation
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 |
|---|---|---|
| Radio-frequency catheter ablationRadio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated. | Device | CARTO3, CARTOUNIVU |
Primary outcome
Fluoroscopy time for each step of atrial fibrillation ablation procedure
Time frame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
Fluoroscopy doses for each step of atrial fibrillation ablation procedure
Time frame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
3 secondary outcomes
Number of patients with adverse events as a measure of safety
Time frame: All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy
Time frame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Total time of atrial fibrillation ablation procedure as a measure of efficacy
Time frame: up to 24 hours
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 Oct 2014.
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
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.
Christopher Piorkowski, M.D. principal investigator
Department of Electrophysiology, University of Dresden - Heart Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio-frequency catheter ablation in people with Atrial Fibrillation, run by Technische Universität Dresden at 1 site in Germany.
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 6 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 Oct 2014. 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 Germany. 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?
Fluoroscopy time for each step of atrial fibrillation ablation procedure (time frame: 1 day ( at the end of each step of atrial fibrillation ablation 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 Oct 2014.