CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times

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

Study Overview

• Status: Recruiting
• Conditions: Flutter
• Intervention / Treatment: Procedure: Confluent areas; Procedure: Wave Speed; Procedure: Voltage; Procedure: CTI line

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.

  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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ermengol Valles, PhD; Phone Number: 0034932483118; Email: evalles@psmar.cat

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
    • Contact: Ermengol Vallès, PhD.; Phone Number: 3456 +34932483456; Email: evalles@psmar.cat
    • Contact: Carlos González, M.D.; Phone Number: 3456 +34932483456; Email: cgonzalezmatos@psmar.cat
    • Principal Investigator: Ermengol Vallès, PhD
    • Principal Investigator: Carlos González, M.D.
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Hospital Germans Tries
      • Contact: Victor Bazan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients submitted to CTI ablation for TF
• Age above 18 years

Exclusion Criteria:

• Life expectancy of <1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Confluent areas; Ablation first of confluent areas of low wave speed and high voltage in the CTI	Procedure: 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); Other Names: Omnipolar; HD Grid catheter
Experimental: Wave Speed; Ablation first of areas of low wave speed in the CTI	Procedure: 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)
Active Comparator: Voltage; Ablation first of areas of high voltage in the CTI	Procedure: 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)
Active Comparator: CTI line; Direct CTI line performance (gold standard)	Procedure: CTI line; Do not use omnipolar information. CTI line performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiofrequency time	Amount of Radiofrequency needed to achieve complete CTI block (acute success)	24 hours
Fluoroscopy time	Amount of Fluroscopy time needed to achieve complete CTI block (acute success)	24 hours
Radiation dose	Amount of Radiation dose needed to achieve complete CTI block (acute success)	24 hours
Zero Fluoroscopy	Percentage of patients performed without the use of fluoroscopy	24 hours
Acute efficay	Percentage of acute succeess (complete block of the CTI)	24 hours
Complications	Percentage of procedural complications	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flutter recurrences	Percentage of recurrences of typical flutter at 6 months follow up	6 months

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Abbott
• Investigators: Principal Investigator: Ermengol Valles, Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OMNIFLUTTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: RedCap database and randomization tool
• IPD Sharing Time Frame: Available by the study initiation, on March 2023, and until the publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes