Advisor HD Grid Observational Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03733392|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment|
|Persistent Atrial Fibrillation Ventricular Tachycardia||Device: Advisor HD Grid Mapping Catheter, Sensor Enabled|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Advisor HD Grid Observational Study|
|Actual Study Start Date :||January 11, 2019|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
- Device: Advisor HD Grid Mapping Catheter, Sensor Enabled
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
- To quantify and characterize the acute- and long-term success rate of RF ablation after electroanatomical mapping with HD Grid and Ensite Precision with HD Wave in subjects with PersAF or VT. [ Time Frame: 6 months (VT) 12 months (Persistent AF) ]The rate of acute success is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). For PersAF, the rate of long-term success rate is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery and have had freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) and a change in class I/III antiarrhythmic drug (AAD) use. For VT, the rate of long-term success is defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery and have had freedom from reoccurrence of sustained monomorphic VT and a change in class I/III AAD use at 6-month follow-up.
- Overall Procedure Time [ Time Frame: During procedure ]Defined as time from initial catheter insertion to final catheter removal
- Radiofrequency Time [ Time Frame: During Procedure ]Defined as duration of time RF energy is delivered
- Fluoroscopy Time [ Time Frame: During Procedure ]Defined as total time subject is exposed to fluorscopy
- Mapping Time Associated with Mapping Arrhythmia [ Time Frame: During Procedure ]Defined as the total cumulative mapping time and mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)
- Number of Mapping Points Collected [ Time Frame: During Procedure ]Defined as total number of mapping points collected for the creation of each map.
- Number of Used Mapping Points Per Minute [ Time Frame: During Procedure ]Defined as the total number of mapping points used divided by the relative mapping time
- Substrate Characteristics Identified [ Time Frame: During Procedure ]For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate.
- Ablation Strategy(s) Used [ Time Frame: During Procedure ]Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.
- Role of HD Wave map relative to along-the-spline map in ablation strategy decision. [ Time Frame: During Procedure ]Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline electrode configurations.
- Maneuverability of HD Grid Catheter [ Time Frame: During Procedure ]Defined as the ability to maneuver the HD Grid to each specified anatomic location if attempted, the ability to contact cardiac tissue, and the incidence of induced ectopic beats during maneuvering.
- HD Grid electrogram quality relative to ablation catheter electrograms [ Time Frame: During Procedure ]Defined as the proportion of electrograms collected with HD Grid that have better quality/less noise than electrograms collected with the ablation catheter at the same cardiac location as assessed by physician survey.
- Change in Quality of Life [ Time Frame: 6 month and 12 month ]Defined as change in quality of life assessed in validated QOL surveys (EQ-5D and AFEQT for subjects with PersAF, EQ-5D and HADS for subjects with VT).
- Rate of periprocedural and immediate post procedural (48hrs) procedure- or device- related adverse events in all subjects in whom the HD Grid is inserted. [ Time Frame: 48 hours ]Adverse Events
- Rate of procedure- or device-related adverse events and cardiovascular serious adverse events in all subjects in whom the HD Grid is inserted . [ Time Frame: 30 days ]Adverse Events
- Proportion of VT subjects who receive HD Grid mapping and RF energy delivery free from recurrence of sustained monomorphic VT and new or increased dose of class I/III AAD, and free from recurrence of sustained monomorphic VT on or off class I/III AAD. [ Time Frame: 90 days to 12 months ]Free from recurrence of sustained monomorphic VT on or off class I/III AADs at 12-month follow-up outside the blanking period.
- Rate of repeat ablations after study procedure during 12-month follow up [ Time Frame: Through 12 months ]Defined as proportion of subjects without an additional ablation procedure to treat indicated cardiac arrhythmia.
- Proportion of atypical atrial flutter identified during procedure for Persistent AF patients. [ Time Frame: During Procedure ]Of those receiving HD Grid mapping and RF ablation for AFL: Utility of HD Grid specific to the identification and treatment of atypical AFL, including role of HD wave relative to along-the-spline maps in identifying ablation target(s), and time of RF application to terminate atypical AFL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733392