Advisor HD Grid Observational Study

Ventricular Tachycardia Clinical Trial

Official title:

Advisor High Density (HD) Grid Mapping Catheter Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733392
• Other study ID #: ABT-CIP-10257
• Status: Completed
• Start date: January 11, 2019
• Est. completion date: May 27, 2021

Study information

• Verified date: April 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called "HD Grid") and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called "EnSite Precision") with HD Wave Solution™ voltage mapping (hereafter called "HD Wave Solution") in subjects with persistent atrial fibrillation (PersAF) or ventricular tachycardia (VT) in real-world clinical settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule 2. Over 18 years of age 3. Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT 4. Subject is diagnosed with either PersAF OR VT as defined by:

a. Persistent AF: i. Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months b. VT: i. Sustained monomorphic ventricular tachycardia with record of VT event within last 6 months and history of prior myocardial infarction

Exclusion Criteria:

1. Life expectancy less than 12 months

2. Women who are pregnant or nursing

3. Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure

4. Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure

5. Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure

6. Documented cerebro-embolic event within the past 12 months (365 days)

7. History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months

8. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)

9. Current acute illness or active systemic infection or sepsis

10. Currently enrolled in another clinical study that could confound the results of this study

11. Any cause for contraindication to ablation procedure or systemic anticoagulation

12. 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 study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results.

13. Vulnerable patient or individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of autonomy

14. Indication-specific exclusion criteria including:

a. PersAF: i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause.

ii. Left atrial diameter (LAD) > 55 mm (parasternal long axis view) iii. Left ventricular ejection fraction (LVEF) < 40% iv. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV v. Presence of implanted implantable cardioverter-defibrillator (ICD)/implantable cardiac resynchronization therapy defibrillator (CRT-D).

b. VT: i. VT/Ventricular Fibrillation (VF) thought to be from channelopathies ii. Active ischemia or other reversible cause of VT iii. Incessant VT at time of procedure iv. Implanted with a ventricular assist device (VAD) (e.g. TandemHeart) v. Chronic NYHA Class IV heart failure vi. Ejection fraction < 15%

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Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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.

Locations

Country	Name	City	State
Australia	Flinders Private Hospital	Bedford Park	South Australia
Australia	The Prince Charles Hospital	Chermside	Qslnd
Australia	Monash Medical Centre	Clayton	Victori
Australia	The Alfred Hospital	Melbourne	New South Wales
Austria	A. ö. Krankenhaus der Elisabethinen Linz	Linz	Upper Austria
Austria	KH Wiener Neustadt	Wiener Neustadt	L Austr
Canada	Institut de Cardiologie de Quebec (Hôpital Laval)	Québec	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Denmark	Skejby University Hospital	Arhus
France	Pole Sante Republique	Clermont-Ferrand	Auvergn
France	Institute Cardio. Paris-Sud - Institut Jacques Cartier	Massy	ILE
France	Clinique Rhena	Strasbourg	Alsace
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden	Saxony
Germany	Klinikum Fürth	Furth	Bavaria
Germany	UKE Hamburg (Universitatsklinik Eppendorf)	Hamburg
Germany	Medizinische Einrichtungen der Universität zu Köln	Koln	N. Rhin
Germany	Herzzentrum Leipzig GmbH	Leipzig	Saxony
Italy	Ospedale Cardinal Massaia Di Asti	Asti	Piedmonte
Italy	Ospedale San Raffaele	Milano	Lombard
Netherlands	Haga Ziekenhuis Locatie Leyenburg	Den Haag	Zuid
Portugal	Santa Maria Hospital	Lisboa	Lisbon
South Africa	Christiaan Barnard Memorial Hospital	Cape Town
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona	Catalon
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabr

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Portugal,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted.	Number of subjects in whom the HD Grid is inserted and experienced periprocedural and immediate post procedural (48hrs) procedure- or device- related adverse events.	48 hours
Other	Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted .	Number of subjects in whom the HD Grid is inserted and experienced procedure- or device-related adverse events and cardiovascular serious adverse events between 48 hours and 30 days post-procedure.	48 hours - 30 days
Other	Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up	Defined as the proportion of subjects free from an additional ablation procedure to treat indicated cardiac arrhythmia (after a blanking period of 90 days) out of the subjects who received HD Grid mapping and RF energy delivery, and either completed 12 months of follow up or did not complete 12 months of follow up but experienced a repeat ablation before withdrawing from the study (PersAF subjects).; Defined as the proportion of subjects free from an additional ablation procedure to treat indicated cardiac arrhythmia (after a blanking period of 14 days) out of the subjects who received HD Grid mapping and RF energy delivery, and either completed 6 months of follow up or did not complete 6 months of follow up but experienced a repeat ablation before withdrawing from the study (VT subjects), excluding subjects in which a device was used off-label.	Through 12 months
Other	Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects	Quality of life (QOL) validated by EQ-5D-5L and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) in PersAF subjects at Baseline, 6 and 12 months after receiving HD Grid mapping and RF ablation.; The visual analogue score (VAS) component of the EQ-5D-5L questionnaire indicate how good or bad a subject's health was on the day the questionnaire was administered. 100 means the best health you can imagine and 0 means the worst health you can imagine.; There are 4 subscales that contribute to the Overall AFEQT Score (Symptoms, Daily Activities, Treatment Concern, and Treatment Satisfaction). The overall AFEQT score is calculated using the first 3 domains and ranges from 0 = worst to 100 = best QoL. Patient satisfaction with treatment is not considered to be a part of a patient's health status and is not included in the summary score calculation.	Baseline, 6 months, 12 months
Other	Quality of Life: EQ-5D-5L Visual Analog Scale Scores in VT Subjects	Quality of Life validated by EQ-5D-5L survey in VT subjects at Baseline, 6 and 12 months after receiving HD Grid mapping and RF ablation. Higher scores mean a better outcome.; The visual analogue score (VAS) component of the EQ-5D-5L questionnaire indicate how good or bad a subject's health was on the day the questionnaire was administered. 100 means the best health you can imagine and 0 means the worst health you can imagine.	Baseline, 6 months, 12 months
Other	Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects	Quality of Life validated by Hospitalization Anxiety and Depression Scale (HADS) survey in VT subjects at Baseline, 6 and 12 months after receiving HD Grid mapping and RF ablation. Percent of subjects scoring in the Normal, Borderline Abnormal, and Abnormal ranges in Anxiety and Depression categories.; Each question on the HADS questionnaire is on a scale of 0-3. 0 mean no anxiety/depression and 3 means high anxiety and depression. All question scores are totaled for a range of 0-21. 0-7 score indicates normal levels of anxiety/depression, 8-10 indicates borderline abnormal anxiety/depression, and 11-21 indicated and abnormal case of anxiety/depression.	Baseline, 6 months, and 12 months
Other	Long-term Success in VT Subjects at 12 Months	Long-term success is defined as the percent of VT subjects who receive HD Grid mapping and RF energy delivery and have had freedom from recurrence of sustained monomorphic VT and a new or increase dose in class I/III AAD at 12-month follow-up. The percent of subjects who are free from the pre-defined endpoints on or off class I/III AADs is also reported.	12 months
Primary	Rate of Subjects With Acute Success	The rate of acute success is defined as the percent of subjects who received HD Grid mapping and RF energy delivery according to label resulting in acute termination of clinical arrhythmia, defined by termination to sinus rhythm (SR) (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt).	Immediate post procedure
Primary	Rate of Subjects With Long-term Success	For PersAF, the rate of long-term success rate is defined as the percent of subjects who receive HD Grid mapping and RF energy delivery according to label 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 new or increased dose in class I/III antiarrhythmic drug (AAD). For VT, the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from recurrence of sustained monomorphic VT and a new or increase dose in class I/III AAD at 6-month follow-up. The percent of subjects who are free from the pre-defined endpoints on or off class I/III AADs is also reported.	PersAF (12 months), VT (6-months)
Secondary	Overall Procedure Time	Overall procedure time is defined as time from initial catheter insertion to final catheter removal.	During procedure
Secondary	Radiofrequency (RF) Time	Defined as duration of time RF energy is delivered	During Procedure
Secondary	Fluoroscopy Time	Defined as total time subject is exposed to fluoroscopy	During Procedure
Secondary	Mapping Time Associated With Mapping Arrhythmia	Defined as the total mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)	During Procedure
Secondary	Number of Mapping Points Collected	Defined as total number of mapping points collected for the creation of each map.	During Procedure
Secondary	Number of Used Mapping Points Per Minute	Defined as the total number of mapping points used divided by the relative mapping time	During Procedure
Secondary	Substrate Characteristics Identified	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.	During Procedure
Secondary	Map Type Used to Define Ablation Strategy	Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.	During Procedure
Secondary	Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.	Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.	During Procedure
Secondary	Maneuverability of HD Grid Catheter	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.	During Procedure
Secondary	HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms	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.	During Procedure
Secondary	Ablation Strategy(s) Used for PersAF Subjects	Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for PersAF; Pulmonary vein isolation (PVI) Right Superior Pulmonary Vein (RSPV) Right Inferior Pulmonary Vein (RIPV) Left Superior Pulmonary Vein (LSPV) Left Inferior Pulmonary Vein (LIPV)	During Procedure
Secondary	Ablation Strategy(s) Used for VT Subjects	Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT.	During the Procedure