Back to resultsHigh-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy (WAVE-MAP AF)
Primary Purpose
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
A specific electrophysiology mapping protocol is applicable with the GRID catheter.
Sponsored by
About this trial
This is an interventional diagnostic trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Documented atrial fibrillation with planned endocardial ablation procedure
- Age 18 years or older
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
- Able and willing to complete all required study procedures through 12 months
Exclusion Criteria:
- Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
- Previous ablation or surgery in the left atria
- Implanted left atrial appendage occluder
- Implanted mitral or tricuspid valve replacement
- Implanted cardiac defibrillator (ICD)
- Participation in another clinical investigation that may confound the results of this study
- Pregnant or nursing
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Life expectancy less than 12 months
Sites / Locations
- Kepler Universitätsklinikum GmbH
- FN U sv. Anny v Brno
- CHR de La Reunion - Site du CHFG
- Hôpital Privé du Confluent
- Médipôle Lyon-Villeurbanne
- Klinikum Ingolstadt GmbH
- Herz- u. Gefäßzentrum Bad Bevensen
- Herz- und Diabeteszentrum NRW
- Ospedale San Raffaele
- Azienda Ospedaliero Universitaria Pisana
- Universitair Medische Centrum Groningen
- Hospital de Santa Cruz
- Complexo Hospitalario Universitario de Santiago
- Hospital Universitario Vall d'Hebron
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mapping protocol with GRID catheter
Arm Description
All patient will undergo a protocol required mapping protocol using the GRID catheter.
Outcomes
Primary Outcome Measures
One-year success
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Survival analysis will be conducted to analyze time-to-event variables.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03882021
Brief Title
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
Acronym
WAVE-MAP AF
Official Title
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
January 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to use the GRID to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.
Detailed Description
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification.
This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.
Approximately 300 subjects at up to 20 sites worldwide will be enrolled.
Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects enrolled will undergo the same mapping and ablation protocol.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mapping protocol with GRID catheter
Arm Type
Other
Arm Description
All patient will undergo a protocol required mapping protocol using the GRID catheter.
Intervention Type
Procedure
Intervention Name(s)
A specific electrophysiology mapping protocol is applicable with the GRID catheter.
Intervention Description
The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.
Primary Outcome Measure Information:
Title
One-year success
Description
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Survival analysis will be conducted to analyze time-to-event variables.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Acute procedural success
Description
Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates, and with exact 95% Clopper-Pearson confidence intervals.
Time Frame
During procedure
Title
Success post blanking period through 12 months using different definitions
Description
Freedom from symptomatic AF/AFL/AT after removal from antiarrhythmic drug therapy
Single procedure clinical success defined as freedom from symptomatic atrial fibrillation, atrial flutter and atrial tachycardia without a new or increased dose of class I or III antiarrhythmic drug
Freedom from atrial fibrillation, atrial flutter and atrial tachycardia Survival analysis will be conducted to analyze time-to-event variables.
Time Frame
12 months
Title
Arrhythmia recurrence
Description
Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies. The data will be summarized with subject counts and percentages/rates, and with exact 95% Clopper-Pearson confidence intervals.
Time Frame
12 months
Title
Left atrium (LA) information
Description
LA volume will be summarized with the numbers of observations, means with standard deviations, quartiles, minimums, maximums and 95%confidence intervals for the means.
Time Frame
During procedure
Title
Left atrium information
Description
LA diameter will be summarized with the numbers of observations, means with standard deviations, quartiles, minimums, maximums and 95%confidence intervals for the means.
Time Frame
During procedure
Title
Reportable Adverse Events
Description
including any device-, procedure-, or death-related events. The data will be summarized with subject counts and percentages/rates, and with exact 95% Clopper-Pearson confidence intervals.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented atrial fibrillation with planned endocardial ablation procedure
Age 18 years or older
Able and willing to provide written informed consent prior to any clinical investigation related procedure
Able and willing to complete all required study procedures through 12 months
Exclusion Criteria:
Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
Previous ablation or surgery in the left atria
Implanted left atrial appendage occluder
Implanted mitral or tricuspid valve replacement
Implanted cardiac defibrillator (ICD)
Participation in another clinical investigation that may confound the results of this study
Pregnant or nursing
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Life expectancy less than 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Ruffner
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Kepler Universitätsklinikum GmbH
City
Linz
State/Province
Upr Aus
ZIP/Postal Code
4021
Country
Austria
Facility Name
FN U sv. Anny v Brno
City
Brno
State/Province
Moravia-Silesia
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
CHR de La Reunion - Site du CHFG
City
Saint-Denis Cedex
State/Province
ILE
ZIP/Postal Code
97405
Country
France
Facility Name
Hôpital Privé du Confluent
City
Nantes
State/Province
Paysdel
ZIP/Postal Code
44200
Country
France
Facility Name
Médipôle Lyon-Villeurbanne
City
Villeurbanne
State/Province
Rhone
ZIP/Postal Code
69626
Country
France
Facility Name
Klinikum Ingolstadt GmbH
City
Ingolstadt
State/Province
Bavaria
ZIP/Postal Code
85049
Country
Germany
Facility Name
Herz- u. Gefäßzentrum Bad Bevensen
City
Bad Bevensen
State/Province
L Saxon
ZIP/Postal Code
29549
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombard
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Tuscany
ZIP/Postal Code
56126
Country
Italy
Facility Name
Universitair Medische Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Hospital de Santa Cruz
City
Carnaxide
State/Province
Lisbon
ZIP/Postal Code
2799-523
Country
Portugal
Facility Name
Complexo Hospitalario Universitario de Santiago
City
Santiago De Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
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