FlutterNCT05709795
CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times
A study testing Confluent areas, Wave Speed and Voltage in people with Flutter, run by Parc de Salut Mar at 2 sites in Spain.
Trial summary
Prospective randomized study involving patients with typical flutter (TF) undergoing cavo-tricuspid isthmus (CTI) radiofrequency ablation. The aim is to compare the results of 3 different new ablation strategies using Omnipolar technology to classic linear ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flutter
- What is being tested?
- Confluent areas, Wave Speed and Voltage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2023to 31 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients submitted to CTI ablation for TF
- Age above 18 years
Who cannot join
- Life expectancy of <1 year
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Germans Tries
Badalona, Barcelona, 08916
Victor Bazan
- Recruiting
Hospital del Mar
Barcelona, 08003
Ermengol Vallès, PhD., +34932483456 ext. 3456, evalles@psmar.cat
Carlos González, M.D., +34932483456 ext. 3456, cgonzalezmatos@psmar.cat
About this study
Prospective randomized study involving patients with typical flutter (TF) undergoing cavo-tricuspid isthmus (CTI) radiofrequency ablation. The aim is to compare the results of 3 different new ablation strategies using Omnipolar technology to classic linear ablation.
The investigators´ aim is to compare the effectiveness, safety and procedure times of CTI ablation with 3 different strategies using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter to optimize radiofrequency (RF) and fluoroscopy times with classical linear ablation.
The number of patients needed to prove the investigators´ hypothesis is of at least 50 per group (total of 200 prospective patients
Read the detailed description
Background Ablation procedures for CTI-dependent TF have classically been guided by fluoroscopy and intracavitary electrograms from diagnostic catheters placed in the right atrium (RA), the coronary sinus (CS) and the CTI (ablation catheter). Over the last few years, the use of navigators has increased considerably not only for complex procedures, but also for simple procedures, with the aim of reducing and even completely eliminating irradiation to both the patient and the operator (1). The investigators´ group is looking to characterize the high voltage and the low velocity regions in the CTI to minimize the procedure times. This has been addressed in a recent observational study with very good results.
Rationale There is increasing evidence of the benefits using 3D-systems not only to diminish fluoroscopy, but also to guide ablation targeting high voltage areas in the CTI (2-5). It is well known also the existence of low speed areas in the CTI, facilitating the presence of reentrant circuits (6,7). Currently, the investigators´ center performs all CTI ablation procedures using a 3D-navigator system, mostly with zero or minimal fluoroscopy. The investigators´ group has carried out a preliminary study with 13 patients to assess the effectiveness of CTI ablation with the use of the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter. In this observational study the investigators were able to characterize the high voltage and the low velocity regions in the CTI to minimize the RF lesions and procedure times. Acute bidirectional block was achieved in 100% of patients with an average fluoroscopy time of 1 ± 2 min (77% patients with zero fluoroscopy) and an average RF time of 5,7 ± 3,2 min (38% below 3 min). This results were significantly lower than results obtained with classical linear ablation: median fluoroscopy time 19.3 min, IQR 12.9 to 36.4 min, median fluoroscopy dose 3520.7 cGycm(2), IQR 1700.0 to 6709.0 cGycm(2).
From the investigators´ point of view this observational study, together with previous evidence justify a randomized study in order to confirm our hypothesis:
Hypothesis Omnipolar technology is able to guide the ablation procedure minimizing both the RF time and the fluoroscopy time (compared to linear ablation) by targeting only the critical regions on the CTI. Therefore Omnipolar technology will diminish RF time and fluoroscopy time/exposition compared to classical CTI ablation, and by means of this the investigators expect an inferior complications rate. Importantly acute success rate and 6 months follow-up recurrences rate will remain similar.
OBJECTIVES
- Primary objectives: to optimize procedure times of CTI ablation with 3 different strategies based in voltage and/or conduction velocity maps using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter compared to classical linear ablation.
- Specific objectives: Fluoroscopy time, radiofrequency time, radiation dose, percentage of zero-fluoroscopy procedures, acute efficacy, complications rate.
- Secondary objectives: to increase the effectiveness of CTI ablation with 3 different strategies based in voltage and/or conduction velocity maps using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter compared to classical linear ablation.
- Specific objectives: Recurrences rate at 6 months.
- Conditions
- Flutter
- Being tested
- Confluent areas, Wave Speed, Voltage, CTI line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confluent areasProcedure or surgery
Also called Omnipolar, HD Grid catheter
Use of omnipolar technology to guide CTI ablation in sites with both low wave speed and high voltage. If not successful then ablation of low wave speed sites. If not successful then ablation of high voltage sites. If not successful then CTI line (gold standard)
Wave SpeedProcedure or surgery
Use of omnipolar technology to guide CTI ablation in sites with low wave speed. If not successful then ablation of sites with both low wave speed and high voltage. If not successful then ablation of high voltage sites. If not successful then CTI line (gold standard)
VoltageProcedure or surgery
Use of omnipolar technology to guide CTI ablation in sites with high voltage. If not successful then ablation of sites with both low wave speed and high voltage. If not successful then ablation of low wave speed sites. If not successful then CTI line (gold standard)
CTI lineProcedure or surgery
Do not use omnipolar information. CTI line performance
| Study group | Role | What they receive |
|---|---|---|
| Confluent areas | Experimental | Ablation first of confluent areas of low wave speed and high voltage in the CTI Receives: Procedure: Confluent areas |
| Wave Speed | Experimental | Ablation first of areas of low wave speed in the CTI Receives: Procedure: Wave Speed |
| Voltage | Active comparator | Ablation first of areas of high voltage in the CTI Receives: Procedure: Voltage |
| CTI line | Active comparator | Direct CTI line performance (gold standard) Receives: Procedure: CTI line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiofrequency time
Amount of Radiofrequency needed to achieve complete CTI block (acute success)
Measured: 24 hours
Fluoroscopy time
Amount of Fluroscopy time needed to achieve complete CTI block (acute success)
Measured: 24 hours
Radiation dose
Amount of Radiation dose needed to achieve complete CTI block (acute success)
Measured: 24 hours
Zero Fluoroscopy
Percentage of patients performed without the use of fluoroscopy
Measured: 24 hours
Acute efficay
Percentage of acute succeess (complete block of the CTI)
Measured: 24 hours
Complications
Percentage of procedural complications
Measured: 2 months
Secondary outcomes (1)
Flutter recurrences
Percentage of recurrences of typical flutter at 6 months follow up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlutterStudies 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
- Prospective randomized multicentric
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Ermengol Vallès, Parc de Salut Mar
- Investigators
- Ermengol Valles, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709795
- Sponsor's protocol ID
- OMNIFLUTTER
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: RedCap database and randomization tool
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times
- ClinicalTrials.gov ID
- NCT05709795
- Acronym / sponsor ID
- OMNIFLUTTER
- Conditions
- Flutter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 2 Feb 2023 (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.
Prospective randomized study involving patients with typical flutter (TF) undergoing cavo-tricuspid isthmus (CTI) radiofrequency ablation. The aim is to compare the results of 3 different new ablation strategies using Omnipolar technology to classic linear ablation.
The investigators´ aim is to compare the effectiveness, safety and procedure times of CTI ablation with 3 different strategies using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter to optimize radiofrequency (RF) and fluoroscopy times with classical linear ablation.
The number of patients needed to prove the investigators´ hypothesis is of at least 50 per group (total of 200 prospective patients
Detailed description
Background Ablation procedures for CTI-dependent TF have classically been guided by fluoroscopy and intracavitary electrograms from diagnostic catheters placed in the right atrium (RA), the coronary sinus (CS) and the CTI (ablation catheter). Over the last few years, the use of navigators has increased considerably not only for complex procedures, but also for simple procedures, with the aim of reducing and even completely eliminating irradiation to both the patient and the operator (1). The investigators´ group is looking to characterize the high voltage and the low velocity regions in the CTI to minimize the procedure times. This has been addressed in a recent observational study with very good results.
Rationale There is increasing evidence of the benefits using 3D-systems not only to diminish fluoroscopy, but also to guide ablation targeting high voltage areas in the CTI (2-5). It is well known also the existence of low speed areas in the CTI, facilitating the presence of reentrant circuits (6,7). Currently, the investigators´ center performs all CTI ablation procedures using a 3D-navigator system, mostly with zero or minimal fluoroscopy. The investigators´ group has carried out a preliminary study with 13 patients to assess the effectiveness of CTI ablation with the use of the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter. In this observational study the investigators were able to characterize the high voltage and the low velocity regions in the CTI to minimize the RF lesions and procedure times. Acute bidirectional block was achieved in 100% of patients with an average fluoroscopy time of 1 ± 2 min (77% patients with zero fluoroscopy) and an average RF time of 5,7 ± 3,2 min (38% below 3 min). This results were significantly lower than results obtained with classical linear ablation: median fluoroscopy time 19.3 min, IQR 12.9 to 36.4 min, median fluoroscopy dose 3520.7 cGycm(2), IQR 1700.0 to 6709.0 cGycm(2).
From the investigators´ point of view this observational study, together with previous evidence justify a randomized study in order to confirm our hypothesis:
Hypothesis Omnipolar technology is able to guide the ablation procedure minimizing both the RF time and the fluoroscopy time (compared to linear ablation) by targeting only the critical regions on the CTI. Therefore Omnipolar technology will diminish RF time and fluoroscopy time/exposition compared to classical CTI ablation, and by means of this the investigators expect an inferior complications rate. Importantly acute success rate and 6 months follow-up recurrences rate will remain similar.
OBJECTIVES
- Primary objectives: to optimize procedure times of CTI ablation with 3 different strategies based in voltage and/or conduction velocity maps using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter compared to classical linear ablation.
- Specific objectives: Fluoroscopy time, radiofrequency time, radiation dose, percentage of zero-fluoroscopy procedures, acute efficacy, complications rate.
- Secondary objectives: to increase the effectiveness of CTI ablation with 3 different strategies based in voltage and/or conduction velocity maps using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter compared to classical linear ablation.
- Specific objectives: Recurrences rate at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Prospective randomized multicentric
| Arm | Type | Receives |
|---|---|---|
| Confluent areas | Experimental | Procedure: Confluent areasAblation first of confluent areas of low wave speed and high voltage in the CTI |
| Wave Speed | Experimental | Procedure: Wave SpeedAblation first of areas of low wave speed in the CTI |
| Voltage | Active comparator | Procedure: VoltageAblation first of areas of high voltage in the CTI |
| CTI line | Active comparator | Procedure: CTI lineDirect CTI line performance (gold standard) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients submitted to CTI ablation for TF
- Age above 18 years
Key exclusion criteria (1 listed)
- Life expectancy of <1 year
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 |
|---|---|---|
| Confluent areasAlso: Omnipolar, HD Grid catheterUse of omnipolar technology to guide CTI ablation in sites with both low wave speed and high voltage. If not successful then ablation of low wave speed sites. If not successful then ablation of high voltage sites. If not successful then CTI line (gold standard) | Procedure or surgery | Confluent areas |
| Wave SpeedUse of omnipolar technology to guide CTI ablation in sites with low wave speed. If not successful then ablation of sites with both low wave speed and high voltage. If not successful then ablation of high voltage sites. If not successful then CTI line (gold standard) | Procedure or surgery | Wave Speed |
| VoltageUse of omnipolar technology to guide CTI ablation in sites with high voltage. If not successful then ablation of sites with both low wave speed and high voltage. If not successful then ablation of low wave speed sites. If not successful then CTI line (gold standard) | Procedure or surgery | Voltage |
| CTI lineDo not use omnipolar information. CTI line performance | Procedure or surgery | CTI line |
Primary outcome
Radiofrequency time
Time frame: 24 hours
Amount of Radiofrequency needed to achieve complete CTI block (acute success)
Fluoroscopy time
Time frame: 24 hours
Amount of Fluroscopy time needed to achieve complete CTI block (acute success)
Radiation dose
Time frame: 24 hours
Amount of Radiation dose needed to achieve complete CTI block (acute success)
Zero Fluoroscopy
Time frame: 24 hours
Percentage of patients performed without the use of fluoroscopy
Acute efficay
Time frame: 24 hours
Percentage of acute succeess (complete block of the CTI)
Complications
Time frame: 2 months
Percentage of procedural complications
1 secondary outcome
Flutter recurrences
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Yes. RedCap database and randomization tool
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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.
Ermengol Valles principal investigator
Hospital del Mar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confluent areas, Wave Speed and Voltage in people with Flutter, run by Parc de Salut Mar at 2 sites in Spain.
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 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Ermengol Valles, PhD (0034932483118, evalles@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiofrequency time (time frame: 24 hours). The study lists 6 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 3 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.