CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times
NCT ID: NCT05709795
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-03-01
2025-01-31
Brief Summary
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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
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Detailed Description
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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.
o 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Confluent areas
Ablation first of confluent areas of low wave speed and high voltage in the CTI
Confluent areas
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 Speed
Ablation first of areas of low wave speed in the CTI
Wave Speed
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)
Voltage
Ablation first of areas of high voltage in the CTI
Voltage
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 line
Direct CTI line performance (gold standard)
CTI line
Do not use omnipolar information. CTI line performance
Interventions
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Confluent areas
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 Speed
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)
Voltage
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 line
Do not use omnipolar information. CTI line performance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age above 18 years
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Parc de Salut Mar
OTHER
Responsible Party
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Ermengol Vallès
Doctor
Principal Investigators
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Ermengol Valles
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Locations
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Hospital Germans Tries
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Victor Bazan
Role: primary
Other Identifiers
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OMNIFLUTTER
Identifier Type: -
Identifier Source: org_study_id
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