NCT05709795

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

November 4, 2022

Last Update Submit

April 2, 2024

Conditions

Flutter

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Flutter recurrences

    6 months

Study Arms (4)

Confluent areas

EXPERIMENTAL

Ablation first of confluent areas of low wave speed and high voltage in the CTI

Procedure: Confluent areas

Wave Speed

EXPERIMENTAL

Ablation first of areas of low wave speed in the CTI

Procedure: Wave Speed

Voltage

ACTIVE COMPARATOR

Ablation first of areas of high voltage in the CTI

Procedure: Voltage

CTI line

ACTIVE COMPARATOR

Direct CTI line performance (gold standard)

Procedure: CTI line

Interventions

Confluent areasPROCEDURE

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)

Also known as: Omnipolar, HD Grid catheter
Confluent areas
Wave SpeedPROCEDURE

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)

Wave Speed
VoltagePROCEDURE

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)

Voltage
CTI linePROCEDURE

Do not use omnipolar information. CTI line performance

CTI line

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Life expectancy of \<1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Germans Tries

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Study Officials

  • Ermengol Valles

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ermengol Valles, PhD

CONTACT

0034932483118evalles@psmar.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient won´t know what strategy has been followed to achieve CTI block
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized multicentric
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 4, 2022

First Posted

February 2, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

RedCap database and randomization tool

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Available by the study initiation, on March 2023, and until the publication

Locations

ES(2)