- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04850508
Validation of the Advisor HD Grid Mapping Catheter in Atrial Fibrillation Ablation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with symptomatic paroxysmal or persistent atrial Fibrillation.1
- Patients referred for a clinically indicated catheter ablation with a plan for PVI only.
- 18-85 year of age at time of consent.
- Able and willing to comply with all protocol requirements.
- Signed patient Informed Consent (ICF).
Exclusion Criteria:
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE. Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV-node reentry tachycardia or right-sided focal ectopic atrial tachycardia may be included.
- Planned for left atrial ablation beyond PVI.
- Uncontrolled heart Failure or NYHA Class III or IV heart failure.
- Left ventricular ejection fraction < 35 %
- Left atrial size > 55 mm diameter on echocardiogram.
- Severe Pulmonary Hypertension
- Reversible causes of AF (electrolyte imbalance, thyroid disease…)
- Poor candidate for general anesthesia or deep sedation
- Anticipated survival < 1 year
- MI or CABG within 3 months, severe valvular disease
- Any documented thromboembolic event within 6 months.
- Contraindication to systemic oral anticoagulation therapy.
- Significant congenital anomaly or medical condition that may affect the integrity of study data.
- Women who are pregnant or breastfeeding.
- Active enrollment in another investigational study involving a drug or device.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of gaps
Time Frame: During the ablation procedure.
|
The primary endpoint is the mean number of gaps identified per patient identified by the HD Grid catheter after standard PVI procedure with the CMC-20 catheter.
|
During the ablation procedure.
|
Location of gaps
Time Frame: During the ablation procedure.
|
The co-primary endpoint is the location of the gaps identified per patient by the HD Grid catheter after standard PVI procedure with the CMC-20 catheter.
|
During the ablation procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Per vein analysis for the presence of any gap.
Time Frame: During the ablation procedure.
|
A per vein analysis will be performed for the presence of any gap as a binary outcome.
|
During the ablation procedure.
|
Per vein analysis for the mean number of gaps.
Time Frame: During the ablation procedure.
|
A per vein analysis will be performed for the mean number of gaps.
|
During the ablation procedure.
|
Per pair of veins analysis for the presence of any gap.
Time Frame: During the ablation procedure.
|
A per pair of veins (left and right separately) analysis will be performed for the presence of any gap as a binary outcome.
|
During the ablation procedure.
|
Per pair of veins analysis for the mean number of gaps.
Time Frame: During the ablation procedure.
|
A per pair of veins (left and right separately) analysis will be performed for the mean number of gaps.
|
During the ablation procedure.
|
Mapping time
Time Frame: During the ablation procedure.
|
Left atrial mapping time for both the CMC-20 and the HD Grid catheter
|
During the ablation procedure.
|
Discrepancies
Time Frame: During the ablation procedure.
|
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.
|
During the ablation procedure.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vikas P Kuriachan, MD, Libin Cardiovascular Institute of Alberta, University of Calgary
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB20-2140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
Abbott Medical DevicesRecruitingAtrial Fibrillation | Paroxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited States, Australia, Belgium, Germany, Spain, Netherlands, France, Austria, Canada, Czechia, Italy, United Kingdom
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
Clinical Trials on Mapping and ablation with the Advisor HD Grid catheter
-
Abbott Medical DevicesCompletedVentricular Tachycardia | Persistent Atrial FibrillationCanada, South Africa, Denmark, Australia, Italy, Austria, France, Germany, Netherlands, Portugal, Spain
-
Abbott Medical DevicesCompletedNon-paroxysmal Atrial Fibrillation | Left Atrial TachycardiaHong Kong, Australia, Italy, Germany, France
-
Abbott Medical DevicesCompletedCardiac Arrhythmia | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationSpain, United Kingdom, Germany, Italy, Austria, Czechia, France, Netherlands, Portugal
-
Imperial College Healthcare NHS TrustBoston Scientific CorporationTerminated
-
Hospital Clinic of BarcelonaCompleted
-
Klinikum-FuerthUniversity of Trieste; Boston Scientific CorporationRecruitingRadiation Exposure | Catheter Ablation | Atrial Flutter TypicalGermany
-
Acutus MedicalWithdrawnSupraventricular TachycardiaIreland
-
Boston Scientific CorporationCompleted
-
Kansas City Heart Rhythm Research FoundationKansas City Heart Rhythm Institute; St. Bernards Medical Center; Sarasota Medical...RecruitingPersistent Atrial FibrillationUnited States
-
Hospital San Carlos, MadridFundación Centro Nacional de Investigaciones Cardiovasculares Carlos IIIRecruitingPersistent Atrial FibrillationSpain