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The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ablation Management |
|
| 2 | Active Comparator | Medical Management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Cardiac Ablation System | Procedure | Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Effectiveness | The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:
| 6 months |
| Acute Safety | The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure. | 7 days |
| Chronic Safety | The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Efficacy | A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:
|
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Structural heart disease of clinical significance including:
Any prior ablation for atrial fibrillation
Enrollment in any other ongoing arrhythmia study
Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
Active infection or sepsis
Any history of cerebral vascular disease including stroke or transient ischemic attacks
Pregnancy or lactation
Left atrial thrombus at the time of ablation
Untreatable allergy to contrast media
Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
History of blood clotting (bleeding or thrombotic) abnormalities
Known sensitivities to heparin or warfarin
Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)
Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arrhythmia Research Center | Scottsdale | Arizona | 85251 | United States | ||
| UCLA Cardiac Arrhythmia Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11583910 | Background | Fuster V, Ryden LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Levy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC, Klein WW, Alonso-Garcia A, Blomstrom-Lundqvist C, De Backer G, Flather M, Hradec J, Oto A, Parkhomenko A, Silber S, Torbicki A; American College of Cardiology/American Heart Association/European Society of Cardiology Board. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary. A Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation): developed in Collaboration With the North American Society of Pacing and Electrophysiology. J Am Coll Cardiol. 2001 Oct;38(4):1231-66. doi: 10.1016/s0735-1097(01)01587-x. No abstract available. | |
| 16908781 |
| Label | URL |
|---|---|
| Company website | View source |
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32 subjects signed Informed Consent forms but withdrew from the study prior to randomization.
The first subject was enrolled on November 28, 2007. The very last ablation procedure was a retreatment ablation procedure for a Medical Management Crossover subject that occurred on May 7, 2010 with the final follow-up on November 1, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ablation Management | Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Class I or III Antiarrhythmic Medications | Drug | Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. |
|
| Procedure conclusion |
| Improvement of Left Atrial Size at 6 Months Compared to Baseline. | Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms. | 6 months |
| Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline. | Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms. | 6 months |
| Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline. | The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic. | 6 months |
| Improved Quality of Life Over 6 Months Compared to Baseline. | The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life. | 6 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Emory Crawford Long Hospital | Atlanta | Georgia | 30308 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States |
| Genesis Medical Center | Davenport | Iowa | 52803 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50309 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Massachusetts General Hospital Cardiac Arrhythmia | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Spectrum Health Research Department | Grand Rapids | Michigan | 49503 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Consultants in Cardiovascular Diseases | Erie | Pennsylvania | 16502 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Texas Heart Institute at St. Luke's Episcopal | Houston | Texas | 77030 | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Background |
| Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. doi: 10.1161/CIRCULATIONAHA.106.177292. No abstract available. |
| 16077418 | Background | Benussi S, Nascimbene S, Calori G, Denti P, Ziskind Z, Kassem S, La Canna G, Pappone C, Alfieri O. Surgical ablation of atrial fibrillation with a novel bipolar radiofrequency device. J Thorac Cardiovasc Surg. 2005 Aug;130(2):491-7. doi: 10.1016/j.jtcvs.2005.01.009. |
| 12591754 | Background | Dill T, Neumann T, Ekinci O, Breidenbach C, John A, Erdogan A, Bachmann G, Hamm CW, Pitschner HF. Pulmonary vein diameter reduction after radiofrequency catheter ablation for paroxysmal atrial fibrillation evaluated by contrast-enhanced three-dimensional magnetic resonance imaging. Circulation. 2003 Feb 18;107(6):845-50. doi: 10.1161/01.cir.0000048146.81336.1d. |
| 16101625 | Background | Dong J, Vasamreddy CR, Jayam V, Dalal D, Dickfeld T, Eldadah Z, Meininger G, Halperin HR, Berger R, Bluemke DA, Calkins H. Incidence and predictors of pulmonary vein stenosis following catheter ablation of atrial fibrillation using the anatomic pulmonary vein ablation approach: results from paired magnetic resonance imaging. J Cardiovasc Electrophysiol. 2005 Aug;16(8):845-52. doi: 10.1111/j.1540-8167.2005.40680.x. |
| Background | Food and Drug Administration Guidance for Industry and FDA Staff: Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation, January 9, 2004. |
| 16159816 | Background | Abreu Filho CA, Lisboa LA, Dallan LA, Spina GS, Grinberg M, Scanavacca M, Sosa EA, Ramires JA, Oliveira SA. Effectiveness of the maze procedure using cooled-tip radiofrequency ablation in patients with permanent atrial fibrillation and rheumatic mitral valve disease. Circulation. 2005 Aug 30;112(9 Suppl):I20-5. doi: 10.1161/CIRCULATIONAHA.104.526301. |
| 16689850 | Background | Fisher JD, Spinelli MA, Mookherjee D, Krumerman AK, Palma EC. Atrial fibrillation ablation: reaching the mainstream. Pacing Clin Electrophysiol. 2006 May;29(5):523-37. doi: 10.1111/j.1540-8159.2006.00388.x. |
| 7206163 | Background | Gajewski J, Singer RB. Mortality in an insured population with atrial fibrillation. JAMA. 1981 Apr 17;245(15):1540-4. |
| 15172273 | Background | de Lima GG, Kalil RA, Leiria TL, Hatem DM, Kruse CL, Abrahao R, Sant'anna JR, Prates PR, Nesralla IA. Randomized study of surgery for patients with permanent atrial fibrillation as a result of mitral valve disease. Ann Thorac Surg. 2004 Jun;77(6):2089-94; discussion 2094-5. doi: 10.1016/j.athoracsur.2003.11.018. |
| 16009793 | Background | Hindricks G, Piorkowski C, Tanner H, Kobza R, Gerds-Li JH, Carbucicchio C, Kottkamp H. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation. 2005 Jul 19;112(3):307-13. doi: 10.1161/CIRCULATIONAHA.104.518837. Epub 2005 Jul 11. |
| 15383047 | Background | Hornero F, Rodriguez I, Bueno M, Buendia J, Dalmau MJ, Canovas S, Gil O, Garcia R, Montero JA. Surgical ablation of permanent atrial fibrillation by means of maze radiofrequency: mid-term results. J Card Surg. 2004 Sep-Oct;19(5):383-8. doi: 10.1111/j.0886-0440.2004.04077.x. |
| 15864238 | Background | Kerr CR, Humphries KH, Talajic M, Klein GJ, Connolly SJ, Green M, Boone J, Sheldon R, Dorian P, Newman D. Progression to chronic atrial fibrillation after the initial diagnosis of paroxysmal atrial fibrillation: results from the Canadian Registry of Atrial Fibrillation. Am Heart J. 2005 Mar;149(3):489-96. doi: 10.1016/j.ahj.2004.09.053. |
| 12756153 | Background | Marrouche NF, Martin DO, Wazni O, Gillinov AM, Klein A, Bhargava M, Saad E, Bash D, Yamada H, Jaber W, Schweikert R, Tchou P, Abdul-Karim A, Saliba W, Natale A. Phased-array intracardiac echocardiography monitoring during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. Circulation. 2003 Jun 3;107(21):2710-6. doi: 10.1161/01.CIR.0000070541.83326.15. Epub 2003 May 19. |
| 15172410 | Background | Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054. |
| 16510747 | Background | Oral H, Pappone C, Chugh A, Good E, Bogun F, Pelosi F Jr, Bates ER, Lehmann MH, Vicedomini G, Augello G, Agricola E, Sala S, Santinelli V, Morady F. Circumferential pulmonary-vein ablation for chronic atrial fibrillation. N Engl J Med. 2006 Mar 2;354(9):934-41. doi: 10.1056/NEJMoa050955. |
| 15005218 | Background | Packer DL, Asirvatham S, Munger TM. Progress in nonpharmacologic therapy of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Dec;14(12 Suppl):S296-309. doi: 10.1046/j.1540-8167.2003.90403.x. No abstract available. |
| 12875749 | Background | Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97. doi: 10.1016/s0735-1097(03)00577-1. |
| Background | PMA P020025 - Summary of Safety and Effectiveness Data: Boston Scientific Corporation Blazer II XP™ Cardiac Ablation Catheter, August 25, 2003. |
| Background | PMA P030031 - Summary of Safety and Effectiveness Data: Biosense Webster Navistar™/Celsius™ThermoCool® Diagnostic/Ablation Deflectable Tip Catheters, November 5, 2004. |
| Background | PMA P040042 - Summary of Safety and Effectiveness Data: Irvine Biomedical, Inc. IBI Therapy™ Dual 8™ Ablation Catheter, November 18, 2005. |
| 12435183 | Background | Saad EB, Cole CR, Marrouche NF, Dresing TJ, Perez-Lugones A, Saliba WI, Schweikert RA, Klein A, Rodriguez L, Grimm R, Tchou P, Natale A. Use of intracardiac echocardiography for prediction of chronic pulmonary vein stenosis after ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2002 Oct;13(10):986-9. doi: 10.1046/j.1540-8167.2002.00986.x. |
| 14623799 | Background | Saad EB, Rossillo A, Saad CP, Martin DO, Bhargava M, Erciyes D, Bash D, Williams-Andrews M, Beheiry S, Marrouche NF, Adams J, Pisano E, Fanelli R, Potenza D, Raviele A, Bonso A, Themistoclakis S, Brachmann J, Saliba WI, Schweikert RA, Natale A. Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation: functional characterization, evolution, and influence of the ablation strategy. Circulation. 2003 Dec 23;108(25):3102-7. doi: 10.1161/01.CIR.0000104569.96907.7F. Epub 2003 Nov 17. |
| 10097231 | Background | Scardi S, Mazzone C, Pandullo C, Goldstein D, Poletti A, Humar F. Lone atrial fibrillation: prognostic differences between paroxysmal and chronic forms after 10 years of follow-up. Am Heart J. 1999 Apr;137(4 Pt 1):686-91. doi: 10.1016/s0002-8703(99)70224-3. |
| 16533249 | Background | Vasamreddy CR, Dalal D, Dong J, Cheng A, Spragg D, Lamiy SZ, Meininger G, Henrikson CA, Marine JE, Berger R, Calkins H. Symptomatic and asymptomatic atrial fibrillation in patients undergoing radiofrequency catheter ablation. J Cardiovasc Electrophysiol. 2006 Feb;17(2):134-9. doi: 10.1111/j.1540-8167.2006.00359.x. |
| 15851264 | Background | Vasamreddy CR, Dalal D, Eldadah Z, Dickfeld T, Jayam VK, Henrickson C, Meininger G, Dong J, Lickfett L, Berger R, Calkins H. Safety and efficacy of circumferential pulmonary vein catheter ablation of atrial fibrillation. Heart Rhythm. 2005 Jan;2(1):42-8. doi: 10.1016/j.hrthm.2004.10.027. |
| 15928285 | Background | Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005 Jun 1;293(21):2634-40. doi: 10.1001/jama.293.21.2634. |
| 9741520 | Background | Chen YJ, Chen SA, Tai CT, Wen ZC, Feng AN, Ding YA, Chang MS. Role of atrial electrophysiology and autonomic nervous system in patients with supraventricular tachycardia and paroxysmal atrial fibrillation. J Am Coll Cardiol. 1998 Sep;32(3):732-8. doi: 10.1016/s0735-1097(98)00305-2. |
| 15184286 | Background | Haissaguerre M, Sanders P, Hocini M, Hsu LF, Shah DC, Scavee C, Takahashi Y, Rotter M, Pasquie JL, Garrigue S, Clementy J, Jais P. Changes in atrial fibrillation cycle length and inducibility during catheter ablation and their relation to outcome. Circulation. 2004 Jun 22;109(24):3007-13. doi: 10.1161/01.CIR.0000130645.95357.97. Epub 2004 Jun 7. |
| 16948740 | Background | Sanders P, Nalliah CJ, Dubois R, Takahashi Y, Hocini M, Rotter M, Rostock T, Sacher F, Hsu LF, Jonsson A, O'Neill MD, Jais P, Haissaguerre M. Frequency mapping of the pulmonary veins in paroxysmal versus permanent atrial fibrillation. J Cardiovasc Electrophysiol. 2006 Sep;17(9):965-72. doi: 10.1111/j.1540-8167.2006.00546.x. |
| 16443526 | Background | Jais P, Hocini M, Sanders P, Hsu LF, Takahashi Y, Rotter M, Rostock T, Sacher F, Clementy J, Haissaguerre M. Long-term evaluation of atrial fibrillation ablation guided by noninducibility. Heart Rhythm. 2006 Feb;3(2):140-5. doi: 10.1016/j.hrthm.2005.11.012. |
| 16118239 | Background | Earley MJ, Abrams DJ, Staniforth AD, Sporton SC, Schilling RJ. Catheter ablation of permanent atrial fibrillation: medium term results. Heart. 2006 Feb;92(2):233-8. doi: 10.1136/hrt.2005.066969. Epub 2005 Aug 23. |
| 16923426 | Background | Nilsson B, Chen X, Pehrson S, Kober L, Hilden J, Svendsen JH. Recurrence of pulmonary vein conduction and atrial fibrillation after pulmonary vein isolation for atrial fibrillation: a randomized trial of the ostial versus the extraostial ablation strategy. Am Heart J. 2006 Sep;152(3):537.e1-8. doi: 10.1016/j.ahj.2006.05.029. |
| 15741228 | Background | Rotter M, Takahashi Y, Sanders P, Haissaguerre M, Jais P, Hsu LF, Sacher F, Pasquie JL, Clementy J, Hocini M. Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. Eur Heart J. 2005 Jul;26(14):1415-21. doi: 10.1093/eurheartj/ehi172. Epub 2005 Mar 1. |
| FG001 | Medical Management | Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ablation Management | Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months. |
| BG001 | Medical Management | Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Number of DC cardioversions in past 4 years | Number of DC cardioversions in past 4 years per subject | Mean | Standard Deviation | cardioversions |
| ||||||||||||||||
| Number of previously failed AADs per subject | Mean | Standard Deviation | antiarrhythmic drugs |
| |||||||||||||||||
| Left Atrial Diameter | Mean | Standard Deviation | centimeters |
| |||||||||||||||||
| Left Ventricular Ejection Fraction | Mean | Standard Deviation | percent |
|
| 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 | Chronic Effectiveness | The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:
| An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation. | Posted | Number | percentage of participants with success | 6 months |
|
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| Primary | Acute Safety | The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure. | An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. | Posted | Mean | 95% Confidence Interval | percentage of participants | 7 days |
|
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| Primary | Chronic Safety | The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered. | An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation. | Posted | Number | participants | 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Efficacy | A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:
| An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation. | Posted | Mean | 95% Confidence Interval | percentage of participants | Procedure conclusion |
|
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| Secondary | Improvement of Left Atrial Size at 6 Months Compared to Baseline. | Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms. | An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation. | Posted | Mean | Standard Deviation | centimeters | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline. | Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms. | An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. | Posted | Mean | Standard Deviation | percent | 6 months |
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| Secondary | Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline. | The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic. | An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. | Posted | Mean | Standard Deviation | AF Symptom Severity Score | 6 months |
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| Secondary | Improved Quality of Life Over 6 Months Compared to Baseline. | The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life. | An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months |
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Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted.
All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Ablation Management | Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months. | 41 | 138 | 25 | 138 | ||
| EG001 | Medical Management | Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization. | 3 | 72 | 3 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| retroperitoneal bleed with right ureter obstruction | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| heart failure | Cardiac disorders | Non-systematic Assessment |
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| cardiac tamponade | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| pseudoaneurysm | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| pulmonary infiltrates | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| drop in hematocrit secondary to ablation | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| anesthesia reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Urinary tract infection with prolonged hospitalization | Renal and urinary disorders | Non-systematic Assessment |
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| hypotension secondary to cardiac tamponade | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| hypotension/cardiogenic shock | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| pneumonia | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| acute respiratory failure | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| stroke | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| post-procedure pericarditis | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| pulmonary vein stenosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| pulmonary vein narrowing, symptomatic | Injury, poisoning and procedural complications | Systematic Assessment |
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| chest pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| pericardial effusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| persistent atrial septal defect secondary to septal puncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| gastrointestinal bleeds | Blood and lymphatic system disorders | Non-systematic Assessment |
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| AF with rapid ventricular response | Cardiac disorders | Non-systematic Assessment |
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| coronary artery disease | Cardiac disorders | Non-systematic Assessment |
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| bradycardia | Cardiac disorders | Non-systematic Assessment |
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| fever unknown origin with prolonged hospitalization | General disorders | Non-systematic Assessment |
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| nausea and vomiting | General disorders | Non-systematic Assessment |
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| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| congestive heart failure | Cardiac disorders | Non-systematic Assessment |
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| sick sinus syndrome with pacemaker insertion | Cardiac disorders | Non-systematic Assessment |
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| microcytic, hypochromic anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Seriously elevated INR | Blood and lymphatic system disorders | Non-systematic Assessment |
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| mitral regurgitation with mitral valve replacement | Cardiac disorders | Non-systematic Assessment |
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| chest discomfort secondary to mitral valve regurgitation | General disorders | Non-systematic Assessment |
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| long QT with PVC's | Cardiac disorders | Non-systematic Assessment |
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| rhythmol induced brugada effect | Cardiac disorders | Non-systematic Assessment |
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| mitral regurgitation with surgical repair | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
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| chest pain | General disorders | Non-systematic Assessment |
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| bradycardia | Cardiac disorders | Non-systematic Assessment |
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- The study population was mostly Caucasian men.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Nelson, Director of Clinical Research | Medtronic | 763-526-2891 | linda.k.nelson@medtronic.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
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| Male |
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| Netherlands |
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| OG001 | Medical Management | Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization. |
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| Medical Management |
Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization. |
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Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization. |
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