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Typical Atrial Flutter clinical trials

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NCT ID: NCT06157437 Not yet recruiting - Clinical trials for Typical Atrial Flutter

An Exploratory Study of Focal Pulse Ablation System in the Treatment of Typical Atrial Flutter

Start date: December 2023
Phase: N/A
Study type: Interventional

This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.

NCT ID: NCT05777850 Recruiting - Catheter Ablation Clinical Trials

High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter

FASD-HP
Start date: October 25, 2022
Phase: N/A
Study type: Interventional

The aim of cavotricuspid isthmus (CTI) dependent flutter ablation is the bidirectional conduction block of CTI. The probability of achieving a permanent bidirectional block at the CTI depends, mainly, on the ablation energy applied and the quality of the obtained lesion. Among the factors that determine the lesion's quality those which have the bigger impact are catheter stability, contact force, power and duration of energy application and the temperature reached at depth.This is a multicenter 1:1 randomized, blinded (open for the operator) study. Two CTI ablation strategies are compared: 1) conventional treatment branch which consists of individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers (Ablation Index >500 at the anterior half of the CTI and >400 at the posterior half with de CARTO 3 system; 2) experimental treatment branch consistent of CTI block using individual high power (90W) short duration (4 seconds) point-by-point applications. The main objective of this study is assessing the non-inferiority of the efficacy and safety of high-power short-duration ablation in patients undergoing typical atrial flutter ablation. Secondary objectives include the comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure and time to atrial flutter recurrence.

NCT ID: NCT04658940 Completed - Clinical trials for Typical Atrial Flutter

AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)

AcQForce AFL
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.

NCT ID: NCT04657055 Recruiting - Clinical trials for Typical Atrial Flutter

AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU)

AFL-EU
Start date: April 23, 2021
Phase: N/A
Study type: Interventional

The Acutus Medical AcQForce Flutter-EU clinical study is a prospective, multi-center, non-randomized global study designed to confirm the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter. The AcQForce Flutter-EU study is a post-market study that will be run in parallel with a US IDE study of similar design. Data will be combined to support a pre-market approval (PMA) application to the US Food and Drug Administration (FDA).

NCT ID: NCT04434599 Withdrawn - Clinical trials for Typical Atrial Flutter

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
Start date: October 30, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03867266 Recruiting - Clinical trials for Typical Atrial Flutter

Typical Atrial Flutter, Ablation Index and Point by Point Ablation

FLAI
Start date: February 20, 2019
Phase:
Study type: Observational

The Ablation of the typical atrial flutter can be considered substantially anatomical, the investigators want to test a protocol that foresees the use a lesion index (AI) and that respects the Inter-Lesion Distance (ILD) ≤ 6 mm on the cavo-tricuspid isthmus (CTI) The investigators want to prove how the introduction of a lesion index combined with the continuity of lesion can allow a "first pass block" of the CTI decreasing total Radio-Frequency (RF) times

NCT ID: NCT01710150 Withdrawn - Clinical trials for Typical Atrial Flutter

Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter

REDUCE AF
Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).

NCT ID: NCT01408485 Completed - Clinical trials for Typical Atrial Flutter

Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

FLEXION-AFL
Start date: November 2011
Phase: N/A
Study type: Interventional

To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.

NCT ID: NCT01401361 Completed - Clinical trials for Typical Atrial Flutter

Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System

CONTACT_AFL
Start date: October 2011
Phase: Phase 3
Study type: Interventional

To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter - Does not result into unacceptable risk of intra-procedural composite serious adverse events and, - Does not affect efficacy of the ablation procedure The study will also evaluate the

NCT ID: NCT00984204 Completed - Clinical trials for Typical Atrial Flutter

Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).