Clinical Trials Logo

Clinical Trial Summary

The primary study concept is to evaluate the superiority of the HD Grid high-density mapping catheter over the current standard 20-pole circular mapping catheter in pulmonary vein isolation (PVI) in atrial fibrillation. A minimum of 20 evaluable subjects with symptomatic atrial fibrillation scheduled for a clinically indicated first PVI ablation will be included.


Clinical Trial Description

Background and Rationale: The main target in atrial fibrillation ablation is the isolation of the pulmonary veins (PVI). This is performed by point-by-point ablation with radiofrequency energy creating 2 circles, one around the left superior and inferior pulmonary vein and one around the right superior and inferior pulmonary vein. The current standard of mapping the pulmonary vein ostia during PVI ablation is a 20-pole circumferential catheter (CMC-20) which collects anatomical and electrical information by moving it in the left atrium and making contact with the atrial wall. Isolation of pulmonary veins is confirmed by other methods such as bidirectional block across the ablation lesions. New technological developments have resulted in high-density mapping, such as the Advisor HD Grid mapping catheter by Abbott. This catheter has a total of 16 electrodes configured in a 4 by 4 matrix. With each electrical wavefront being decomposed to 2 orthogonal vectors, every direction of a local wavefront should be detected by these configurations and thus overcoming the bipolar blindness. Research Question and Objectives: The primary objective of this study is to demonstrate the superiority of the HD Grid catheter when compared to the CMC-20 catheter in atrial fibrillation ablation. The primary endpoint is the mean number of gaps identified per patient, and their location identified by the HD Grid catheter after standard PVI procedure with the CMC-20 catheter. Secondary endpoints are: - A per vein analysis will be performed for the presence of gaps and for the mean number of gaps. - A per pair of veins (left and right separately) analysis will be performed for the presence of gaps and for the mean number of gaps. - Left atrial mapping time for both the CMC-20 and the HD Grid catheter - Discrepancies in the prevalence of low voltage areas defined as a voltage <0.50 mV between the CMC-20 and HD Grid catheter in sinus rhythm. Design: Prospective, single arm, single center, superiority study with comparison of standard 20-pole circular mapping catheter and the new HD Grid multipolar catheter. A minimum of 20 evaluable subjects with drug refractory, symptomatic atrial fibrillation scheduled for first PVI ablation will be enrolled over a period of 12 months. Data collection: Demographic, clinical and AF-related information will be collected prior to the procedure. Procedure related information will be collected directly after the procedure. All data will be collected in RedCap. Procedure: First, a standard PVI procedure is performed. After completion of the ablation lesions, isolation of the pulmonary veins will be confirmed using the standard CMC-20 catheter. If isolation is confirmed, the CMC-20 catheter will be exchanged for the HD Grid catheter. Using the HD Grid catheter, a new map of the left atrium will be made using the high-density settings. Together with the left atrium, the pulmonary veins will be mapped again in search of electro-anatomical gaps. Gaps are defined as a local area from the ablation line reaching inwards the pulmonary vein which still shows activation or fractionated potentials in line with atrial activation whilst pacing remote in the left atrium. The prevalence and location of these gaps will be collected using the map. If gaps have been found, HD Grid guided additional ablation must be performed to achieve isolation in that vein. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04850508
Study type Observational
Source University of Calgary
Contact Vikas P. Kuriachan, MD
Phone 4039443282
Email [email protected]
Status Recruiting
Phase
Start date September 27, 2021
Completion date May 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Recruiting NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A
Completed NCT03313167 - Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
Active, not recruiting NCT04544397 - Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
Completed NCT02923414 - Comparison of High Versus Escalating Shocks in Cardioverting Atrial Fibrillation N/A
Recruiting NCT04590898 - Peri-device Leakage Closure After LAAO
Completed NCT03593486 - Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation N/A
Active, not recruiting NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Recruiting NCT05080712 - Progression of Atrial Fibrillation in the Young
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Terminated NCT04076917 - Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
Active, not recruiting NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Not yet recruiting NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Recruiting NCT04037397 - First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3) Phase 3