Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study — FLUTTER

Typical Atrial Flutter Clinical Trial

Official title:
Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study

Status Withdrawn

Clinical Trial Summary

Catheter ablation is a first-line treatment for patients with cavotricuspid isthmus (CTI) dependent atrial flutter (AFL; also known as typical AFL), a common arrhythmia. This is done using radiofrequency (RF) catheters and single-procedure success is approximately 95%. Ablation is often done using one of three methods: 1. fluoroscopically, using X-rays to guide the operator to visualise catheter position within the heart. This method involves the most radiation exposure to patient and operator. Ablation is generally performed for a set time-period (eg. 30-60secs) to ensure each ablation lesion is successful. 2. using a 3-dimensional mapping system which allows the catheters to be magnetically located and visualised on a monitor without X-rays, and using "contact force" (CF) sensing catheters. This requires minimal X-ray use, and by ensuring a minimum degree of force between catheter tip and the heart before applying RF for a set time-period (eg. 30 seconds), operators can be more confident of successful lesions. 3. using an ultra-high density mapping system which uses magnetic tracking as above, but allows higher resolution visualisation of the cardiac electrical system with potential for improving procedure success; this has not yet been formally evaluated for AFL. Catheters using this method use "local impedance" (LI) instead of CF. This is a direct measure of heart tissue impedance with real-time changes during ablation. A minimum drop or plateau in the LI value during ablation allows confidence of lesion success, without the need to ablate for a pre-defined time-period. This could potentially reduce ablation time and subsequent complications, but has also not yet been formally compared to the above for this indication. This prospective randomised study aims to compare these three standard of care procedures to determine if differences in ablation metrics, efficacy and safety exist.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04434599
Study type	Interventional
Source	University of Manchester
Contact
Status	Withdrawn
Phase	N/A
Start date	October 30, 2022
Completion date	January 1, 2024

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT05777850` - High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter	N/A
Completed	`NCT01401361` - Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System	Phase 3
Completed	`NCT00984204` - Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)	Phase 3
Withdrawn	`NCT01710150` - Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter	N/A
Completed	`NCT01408485` - Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter	N/A
Completed	`NCT04658940` - AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)	N/A
Recruiting	`NCT00750711` - Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters	N/A
Recruiting	`NCT03867266` - Typical Atrial Flutter, Ablation Index and Point by Point Ablation
Not yet recruiting	`NCT06157437` - An Exploratory Study of Focal Pulse Ablation System in the Treatment of Typical Atrial Flutter	N/A
Recruiting	`NCT04657055` - AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.