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

Paroxysmal Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882021
• Other study ID #: ABT-CIP-10275
• Status: Completed
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: January 13, 2022

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 13, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Documented atrial fibrillation with planned endocardial ablation procedure

2. Age 18 years or older

3. Able and willing to provide written informed consent prior to any clinical investigation related procedure

4. Able and willing to complete all required study procedures through 12 months

Exclusion Criteria:

1. Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration

2. Previous ablation or surgery in the left atria

3. Implanted left atrial appendage occluder

4. Implanted mitral or tricuspid valve replacement

5. Implanted cardiac defibrillator (ICD)

6. Participation in another clinical investigation that may confound the results of this study

7. Pregnant or nursing

8. 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.

9. Life expectancy less than 12 months

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmia
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• A specific electrophysiology mapping protocol is applicable with the GRID catheter.
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.

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum GmbH	Linz	Upr Aus
Czechia	FN U sv. Anny v Brno	Brno	Moravia-Silesia
France	Hôpital Privé du Confluent	Nantes	Paysdel
France	CHR de La Reunion - Site du CHFG	Saint-Denis Cedex	ILE
France	Médipôle Lyon-Villeurbanne	Villeurbanne	Rhone
Germany	Herz- u. Gefäßzentrum Bad Bevensen	Bad Bevensen	L Saxon
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Klinikum Ingolstadt GmbH	Ingolstadt	Bavaria
Italy	Ospedale San Raffaele	Milano	Lombard
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	Tuscany
Netherlands	Universitair Medische Centrum Groningen	Groningen
Portugal	Hospital de Santa Cruz	Carnaxide	Lisbon
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Complexo Hospitalario Universitario de Santiago	Santiago De Compostela	Galicia
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Czechia,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute procedural success	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.	During procedure
Other	Success post blanking period through 12 months using different definitions	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.	12 months
Other	Arrhythmia recurrence	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.	12 months
Other	Left atrium (LA) information	LA volume will be summarized with the numbers of observations, means with standard deviations, quartiles, minimums, maximums and 95%confidence intervals for the means.	During procedure
Other	Left atrium information	LA diameter will be summarized with the numbers of observations, means with standard deviations, quartiles, minimums, maximums and 95%confidence intervals for the means.	During procedure
Other	Reportable Adverse Events	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.	12 months
Primary	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.	12 months