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This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only paroxysmal atrial fibrillation will be considered.) Eligible subjects will be randomized into one of two arms in the study: (1) targeted CFAE ablation or (2) generalized CFAE ablation. Both techniques will then be followed by PVAI (pulmonary vein antral isolation) as part of a hybrid ablation strategy. The nature of the ablation procedures does not allow physicians to be blinded to the randomization.
The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of (1) acute effects on AFCL (atrial fibrillation cycle length), AF regularization, and AF termination; (2) number and distribution of lesion sets delivered; and (3) long term effects on procedural outcome when combined with PVAI as a hybrid strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1) targeted CFAE ablation | Active Comparator |
| |
| (2) generalized CFAE ablation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CFAE ablation | Procedure | CFAE ablation (targeted vs. generalized) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year. | Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure. | From day 91 to day 365 post first ablation procedure |
| Total Radio-frequency (RF) Delivery Time During CFAE | Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure. | Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Ablation Procedure | Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms. | Duration of ablation procedure (up to about 5 hours) |
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Inclusion Criteria:
Candidates for this study must meet ALL of the following criteria:
Age ≥ 18 years old
First-time ablation procedure for AF
Symptomatic AF which has been refractory to at least one antiarrhythmic medication (AAD). "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the above
One of the following must apply:
At least one episode of AF must have been documented by ECG, Holter, TTM, or telemetry strip within 24 months of inclusion in the study.
Patients must be able and willing to provide written informed consent to participate in the study.
Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions apply:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Hendricks | Biosense Webster, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24425420 | Derived | Verma A, Sanders P, Champagne J, Macle L, Nair GM, Calkins H, Wilber DJ. Selective complex fractionated atrial electrograms targeting for atrial fibrillation study (SELECT AF): a multicenter, randomized trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):55-62. doi: 10.1161/CIRCEP.113.000890. Epub 2014 Jan 14. |
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Among the 86 consented subjects, two were excluded prior to randomization; one was excluded due to thrombus found on pre-procedure echo. Hence only 83 subjects were randomized to the two treatment arms and underwent radio-frequency ablation
The first subject of the study was consented on August 17, 2009. The final follow-up was performed on November 14, 2011. The total study duration was approximately 27 months. A total of 86 subjects were enrolled from 7 participating sites; 2 sites in the United States (US), 4 sites in Canada, and 1 site in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Targeted CFAE Ablation | Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time. |
| FG001 | Generalized CFAE Ablation | Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population is based on enrolled subjects (86) who had demographic information. Four subjects, who didn't have demographic data, were excluded from baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Targeted CFAE Ablation | Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time. |
| 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 | Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year. | Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure. | Per-protocol population - subjects who underwent repeat ablation procedures within six months of initial procedures. | Posted | Number | participants | From day 91 to day 365 post first ablation procedure |
|
12 months post procedure follow up.
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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 | Targeted CFAE Ablation | Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Harris, Sr. Clinical Research Associate, Clinical Operations | Biosense Webster EMEA | (800) 729-9010 | eharris@its.jnj.com |
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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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| Fluoroscopy Time | Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms. Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis. | Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) |
| Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target | Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target | Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours) |
| Incidence of Atrial Fibrillation (AF) Termination/Regularization | Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure. | Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Hamilton Health Sciences Centre | Hamilton | Ontario | Canada |
| Southlake Regional Health Center | Newmarket | Ontario | Canada |
| Montreal Heart Institute | Montreal | Quebec | Canada |
| Hopital Laval - Institut universitaire de cardiologie et de pneumonologie | Québec | Quebec | G1V 4G5 | Canada |
| BG001 | Generalized CFAE Ablation | Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Atrial fibrillation type | Number | participants |
|
| Duration of Atrial fibrillation diagnosis (Year) | Mean | Standard Deviation | years |
|
| OG001 | Generalized CFAE Ablation | Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time. |
|
|
|
| Primary | Total Radio-frequency (RF) Delivery Time During CFAE | Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure. | Posted | Mean | Standard Deviation | Minutes | Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) |
|
|
|
|
| Secondary | Duration of Ablation Procedure | Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms. | Per-protocol population with available outcome data | Posted | Mean | Standard Deviation | Minutes | Duration of ablation procedure (up to about 5 hours) |
|
|
|
| Secondary | Fluoroscopy Time | Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms. Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis. | Per-protocol population with available outcome data | Posted | Mean | Standard Deviation | Minutes | Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) |
|
|
|
| Secondary | Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target | Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target | Per-protocol population with available outcome data | Posted | Mean | Standard Deviation | Milliseconds | Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours) |
|
|
|
| Secondary | Incidence of Atrial Fibrillation (AF) Termination/Regularization | Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure. | Per-protocol population with available outcome data | Posted | Number | participants | Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) |
|
|
|
| 15 |
| 42 |
| 29 |
| 42 |
| EG001 | Generalized CFAE Ablation | Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time. | 11 | 41 | 31 | 41 |
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Atrial Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
|
| Heart Block | Cardiac disorders | Systematic Assessment |
|
| Pacemaker | Cardiac disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Sinus Node Disease | Cardiac disorders | Systematic Assessment |
|
| Sinus Node Injury | Cardiac disorders | Systematic Assessment |
|
| Tachy-Brady Syndrome | Cardiac disorders | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Pruritus | General disorders | Systematic Assessment |
|
| Parasite | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vascular Access Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vocal Chord Paralysis | Nervous system disorders | Systematic Assessment |
|
| Vaginal Prolapse | Reproductive system and breast disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Cardioversion | Cardiac disorders | Systematic Assessment |
|
| Chest Discomfort | Cardiac disorders | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
|
| Medication Reaction | Cardiac disorders | Systematic Assessment |
|
| Mild Blunting | Cardiac disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Pericardial Separation | Cardiac disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Tachycardia NEC | Cardiac disorders | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Hearing Loss | Ear and labyrinth disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Cataract Surgery | Eye disorders | Systematic Assessment |
|
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Visual Disturbance or Impairment | Eye disorders | Systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal Bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Dermatitis | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fluid Overload | General disorders | Systematic Assessment |
|
| Hematoma | General disorders | Systematic Assessment |
|
| Localized Edema | General disorders | Systematic Assessment |
|
| Low Potassium | General disorders | Systematic Assessment |
|
| Medication Reaction | General disorders | Systematic Assessment |
|
| Pedial Edema | General disorders | Systematic Assessment |
|
| Post Procedural Elevated Blood Sugar | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Rash | General disorders | Systematic Assessment |
|
| Wound Complication | General disorders | Systematic Assessment |
|
| Elevated Liver Enzymes | Hepatobiliary disorders | Systematic Assessment |
|
| Shingles | Immune system disorders | Systematic Assessment |
|
| Dysuria | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Anesthesia Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Glossodynia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Groin Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leg Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ruptured Tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headaches | Nervous system disorders | Systematic Assessment |
|
| Trouble Concentrating | Nervous system disorders | Systematic Assessment |
|
| Vasovagal Response | Nervous system disorders | Systematic Assessment |
|
| Suicidal | Psychiatric disorders | Systematic Assessment |
|
| Increased Urine Output | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Phrenic Nerve Damage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypertension | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
The PI is allowed to publish but must submit draft pubs to Biosense Webster, Inc. at least 30 days prior to submission for publication or presentation.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Procedure Time to Mapping |
|
| Procedure Time to Ablation and Verification |
|
| Fluoroscopy Time to Mapping |
|
| Fluoroscopy Time to Ablation and Verification |
|