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| Name | Class |
|---|---|
| AFTx, Inc. | INDUSTRY |
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This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.
ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs) during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a novel computational mapping algorithm (CMA) could identify FIs and rotors, and characterize rotors when incidental ablation resulted in rhythm changes. Three-dimensional (3D) left atrial electroanatomic maps were created from signals recorded from multipolar circular mapping catheters in 61 patients undergoing persistent AF ablation. Forty of 61acquired patient datasets were of adequate quality for analysis CMA, employing an AF pattern recognition algorithm, creating 3D panoramic AF maps identifying drivers of AF (FI and rotors) post procedure. Rotors were further classified as substrate (SBR) or non-substrate based (NSBR) on the basis of rotor stability, proximity to voltage transition zones and complex fractionated atrial electrograms (CFAEs). Incidentally ablated identified AF drivers, including SBRs and NSBRs, were evaluated for rhythm changes. A total of 172 drivers were identified in 40 patients (2.2 drivers/patient). Seventy percent were rotors (120/172) and 30% were FIs (52/172). Sixty-seven percent of rotors were classified as SBR vs 33% as NSBR. Incidental ablation of SBRs resulted in rhythm change 91% of the time versus only 24% of the time for NSBR (p<0.0001).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computational Mapping Algorithm | Experimental | AF mapping (utilizing CMA) will be performed and used to point the operator to regions within a heart chamber that should be interrogated further for suspicious electrogram activity, as measured by the St. Jude Ensite System, and ablated if the suspicious electrogram activity persists. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computational Mapping Algorithm | Device | This software enables high resolution temporospatial mapping of atria for the identification of drivers of AF. CMA receives data from standard of care, commercially available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a unique way. Electrogram and anatomy data are fed from the commercially available 3D Mapping System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. CMA then processes the electrogram data and generates a map of where the potential AF driver domains are located and superimposes those potential AF driver domain targets onto the 3D geometry of the anatomy (provided by the 3D mapping system). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Atrial Fibrillation Termination | Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT) | Day 1 |
| Number of Participants Free From Recurrent AT/AF on no AAD | Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD) | at 12 months |
| Number of Participants Free From Recurrent AT/AF With no or Some AAD | Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Post-ablation Inducibility of AF | Post-ablation inducibility of AF (> 5 mins) with burst pacing | Day 1 |
| Duration of RF Ablation | Amount of radiofrequency ablation used for atrial fibrillation ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Medical Center | Denver | Colorado | 80045 | United States | ||
| South Denver Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31944826 | Derived | Choudry S, Mansour M, Sundaram S, Nguyen DT, Dukkipati SR, Whang W, Kessman P, Reddy VY. RADAR: A Multicenter Food and Drug Administration Investigational Device Exemption Clinical Trial of Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Jan;13(1):e007825. doi: 10.1161/CIRCEP.119.007825. Epub 2020 Jan 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | De Novo | Participants with 1st procedure |
| FG001 | Re-Do Ablation | Participants who need a re-do ablation procedure |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | De Novo | Participants with 1st procedure |
| BG001 | Re-Do Ablation | Participants who need a re-do ablation procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Atrial Fibrillation Termination | Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT) | Posted | Count of Participants | Participants | Day 1 |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | De Novo | Participants with 1st procedure | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amiodarone induced ataxia | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Cammack | Icahn School of Medicine at Mount Sinai | 212-824-8931 | sam.cammack@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2017 | Mar 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Day 1 |
| Duration of Fluoro Time | Duration of fluoroscopy used during the AF ablation procedure | Day 1 |
| Duration of Exposure | Radiation exposure due to fluoroscopy during the AF ablation procedure | Day 1 |
| Duration of Procedure Time | Duration of RADAR procedure time | Day 1 |
| Number of Procedure-related Adverse Events | up to 12 months |
| Number of Major Adverse Cardiac Events (MACE) | 12 months |
| Number of Serious Adverse Events | 12 months |
| Denver |
| Colorado |
| 80120 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number of Participants Free From Recurrent AT/AF on no AAD | Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD) | Posted | Count of Participants | Participants | at 12 months |
|
|
|
| Primary | Number of Participants Free From Recurrent AT/AF With no or Some AAD | Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs | Posted | Count of Participants | Participants | at 12 months |
|
|
|
| Secondary | Rate of Post-ablation Inducibility of AF | Post-ablation inducibility of AF (> 5 mins) with burst pacing | Posted | Number | percent of occurences | Day 1 |
|
|
|
| Secondary | Duration of RF Ablation | Amount of radiofrequency ablation used for atrial fibrillation ablation | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Duration of Fluoro Time | Duration of fluoroscopy used during the AF ablation procedure | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Duration of Exposure | Radiation exposure due to fluoroscopy during the AF ablation procedure | Posted | Mean | Standard Deviation | mGy | Day 1 |
|
|
|
| Secondary | Duration of Procedure Time | Duration of RADAR procedure time | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Number of Procedure-related Adverse Events | Posted | Number | events | up to 12 months |
|
|
|
| Secondary | Number of Major Adverse Cardiac Events (MACE) | Posted | Number | events | 12 months |
|
|
|
| Secondary | Number of Serious Adverse Events | Posted | Number | events | 12 months |
|
|
|
| 38 |
| 10 |
| 38 |
| 8 |
| 38 |
| EG001 | Re-Do Ablation | Participants who need a re-do ablation procedure | 0 | 26 | 5 | 26 | 3 | 26 |
| Amiodarone Intolerance | General disorders | Systematic Assessment |
|
| Blood in stool | Gastrointestinal disorders | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | lung infection |
|
| Cellulitis with lower back abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| COPD Exacebation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fever | Infections and infestations | Systematic Assessment |
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| Gastroesophageal bleed with hypotension | Gastrointestinal disorders | Systematic Assessment |
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| Generalized Weakness | General disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Non-sustained Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Prostatectomy | Renal and urinary disorders | Systematic Assessment |
|
| Pseudoaneurysm of right femoral artery | Vascular disorders | Systematic Assessment | with retroperitoneal hemorrhage |
|
| Severe Mitral Valve Regurgitation, and Paroxysmal Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Severe three vessel coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Shortness of breath and abdominal rash | General disorders | Systematic Assessment |
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| Upper GI bleed | Gastrointestinal disorders | Systematic Assessment |
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| Worsening heart failure with influenza | Cardiac disorders | Systematic Assessment |
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| Cogitive Decline | Nervous system disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Atypical flutter with RVR | Cardiac disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Fluid Overload | Cardiac disorders | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Lower extremity edema | Vascular disorders | Systematic Assessment | lower extremity edema with dyspnea and subsequent hypokalemia with diuresis |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Peripheral Edema | Cardiac disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Recurrent Left Pleural Effusions | Cardiac disorders | Systematic Assessment |
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| Symptomatic PVCs | Cardiac disorders | Systematic Assessment |
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| Vaginitis | Renal and urinary disorders | Systematic Assessment |
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| Vertigo (Labyrinthitis) | General disorders | Systematic Assessment |
|
| VF with ICD Shock | Cardiac disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |