Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL083359 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Survival Free of Atrial Fibrillation | Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds. | 6 -12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Termination or Slowing of Atrial Fibrillation During Ablation | Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus. | acute |
Not provided
Inclusion Criteria:
Not provided
Not provided
Subjects will be men and women of all races aged 21 to 80 years undergoing clinically indicated ablation of Atrial Fibrillation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanjiv M. Narayan, MD, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| VA San Diego Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22818076 | Result | Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18. | |
| 22537106 | Result | Narayan SM, Krummen DE, Rappel WJ. Clinical mapping approach to diagnose electrical rotors and focal impulse sources for human atrial fibrillation. J Cardiovasc Electrophysiol. 2012 May;23(5):447-54. doi: 10.1111/j.1540-8167.2012.02332.x. Epub 2012 Apr 26. |
Not provided
Not provided
Recruitment from medical clinic.
Recruitment from medical clinic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FIRM-Guided | Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI) |
| FG001 | CONVENTIONAL | Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
From Medical Record
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FIRM-Guided | Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI) |
| BG001 | CONVENTIONAL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Survival Free of Atrial Fibrillation | Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds. | Posted | Number | participants | 6 -12 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FIRM-Guided | Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | Systematic Assessment | Blood in pericardium causing hemodynamic compromise, that requires drainage. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjiv Narayan (Professor of Medicine, Principal Investigator) | University of California, San Diego | (650) 498-8161 | sanjiv1@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| San Diego |
| California |
| 92161 |
| United States |
| 22465458 | Result | Narayan SM, Patel J, Mulpuru S, Krummen DE. Focal impulse and rotor modulation ablation of sustaining rotors abruptly terminates persistent atrial fibrillation to sinus rhythm with elimination on follow-up: a video case study. Heart Rhythm. 2012 Sep;9(9):1436-9. doi: 10.1016/j.hrthm.2012.03.055. Epub 2012 Mar 28. No abstract available. |
| 23563126 | Result | Narayan SM, Krummen DE, Clopton P, Shivkumar K, Miller JM. Direct or coincidental elimination of stable rotors or focal sources may explain successful atrial fibrillation ablation: on-treatment analysis of the CONFIRM trial (Conventional ablation for AF with or without focal impulse and rotor modulation). J Am Coll Cardiol. 2013 Jul 9;62(2):138-147. doi: 10.1016/j.jacc.2013.03.021. Epub 2013 Apr 3. |
| 23392583 | Result | Narayan SM, Shivkumar K, Krummen DE, Miller JM, Rappel WJ. Panoramic electrophysiological mapping but not electrogram morphology identifies stable sources for human atrial fibrillation: stable atrial fibrillation rotors and focal sources relate poorly to fractionated electrograms. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):58-67. doi: 10.1161/CIRCEP.111.977264. Epub 2013 Feb 7. |
| 24632280 | Result | Narayan SM, Baykaner T, Clopton P, Schricker A, Lalani GG, Krummen DE, Shivkumar K, Miller JM. Ablation of rotor and focal sources reduces late recurrence of atrial fibrillation compared with trigger ablation alone: extended follow-up of the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation). J Am Coll Cardiol. 2014 May 6;63(17):1761-8. doi: 10.1016/j.jacc.2014.02.543. Epub 2014 Mar 13. |
Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Termination or Slowing of Atrial Fibrillation During Ablation | Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus. | Posted | Count of Participants | Participants | acute |
|
|
|
| 2 |
| 36 |
| 0 |
| 36 |
| EG001 | CONVENTIONAL | Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping. | 6 | 71 | 0 | 71 |
|
| Groin bleed requiring transfusion | Blood and lymphatic system disorders | Systematic Assessment | Groin bleed requiring transfusion |
|
| Symptomatic Pulmonary Vein Stenosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Symptomatic Pulmonary Vein Stenosis |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |