Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pro00036518 | Other Identifier | Duke Site Protocol Number |
Not provided
Not provided
Main objectives of the study were met; consensus among investigators that continuing the study would not add new information beyond that already learned.
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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
Not provided
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The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in patients with an implantable cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.
This study will be conducted at up to 8 sites and will randomize 50 patients over 1 year to a strategy of catheter ablation (n=25) vs. state-of-the-art pharmacologic therapy (n=25). To be considered for enrollment in this pilot trial, patients must be at least 18 years of age and must have an ICD for a primary or secondary prevention indication, have ≥ 1 documented ICD shock or ≥ 3 ATP therapies for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy and be eligible for both catheter ablation and at least 1 antiarrhythmic medication. Patients will be followed at 3 and 6 months and their vital status will be determined via a phone call at 12 months. Data on the safety and efficacy of therapies used in the pilot study will be collected. Of particular interest are adverse events resulting from the catheter ablation procedure and major side effects from antiarrhythmic medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter ablation | Other | The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults |
|
| Antiarrhythmic medication | Other | The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amiodarone | Drug | The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completed Month 3 Follow-Up | Records participants who completed Month 3 Follow-Up Visit | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completed Month 6 Follow-Up | Records participants who completed Month 6 Follow-Up Visit | 6 Months |
| Number of Participants Had at Least One of the Efficacy Outcome Measurement |
Not provided
Inclusion Criteria:
Exclusion:
Not provided
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Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Sana M Al-Khatib, MD, MHS | Duke University | Principal Investigator |
| William Stevenson, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8239250 | Background | Myerburg RJ, Kessler KM, Castellanos A. Sudden cardiac death: epidemiology, transient risk, and intervention assessment. Ann Intern Med. 1993 Dec 15;119(12):1187-97. doi: 10.7326/0003-4819-119-12-199312150-00006. | |
| 7913885 | Background | Gilman JK, Jalal S, Naccarelli GV. Predicting and preventing sudden death from cardiac causes. Circulation. 1994 Aug;90(2):1083-92. doi: 10.1161/01.cir.90.2.1083. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Catheter Ablation | The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| sotalol | Drug | The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. |
|
|
| Biosense Webster's NAVI-STAR Thermo-Cool | Device | The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults. |
|
Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)
| 6 Months |
| Cardiovascular Hospitalizations | Records participants hospitalized for VT during the study | Baseline, 6 months |
| Number of Participants Remained on Randomized Treatment Assignment | Records participants who only received study treatment as randomized during the entire study | 6 month |
| Number of Participants Switched to Other Arm | Records participants who received study treatment as randomized and later switched to other treatment arm during the study | 6 months |
| Time to First Recurrent ICD Therapy for VT | Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT. | Baseline, 6 months |
| Number of Participants Received Treatment Assigned | Records participants who received study randomized treatment during the study | 6 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15237 | United States |
| 9826323 | Background | Zipes DP, Wellens HJ. Sudden cardiac death. Circulation. 1998 Nov 24;98(21):2334-51. doi: 10.1161/01.cir.98.21.2334. No abstract available. |
| 11684624 | Background | Zheng ZJ, Croft JB, Giles WH, Mensah GA. Sudden cardiac death in the United States, 1989 to 1998. Circulation. 2001 Oct 30;104(18):2158-63. doi: 10.1161/hc4301.098254. |
| 9411221 | Background | Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997 Nov 27;337(22):1576-83. doi: 10.1056/NEJM199711273372202. |
| 11907286 | Background | Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19. |
| 15152060 | Background | Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004 May 20;350(21):2151-8. doi: 10.1056/NEJMoa033088. |
| 15659722 | Background | Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399. |
| 18483207 | Background | Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008 May 27;117(21):e350-408. doi: 10.1161/CIRCUALTIONAHA.108.189742. Epub 2008 May 15. No abstract available. |
| 17765637 | Background | Hammill SC, Stevenson LW, Kadish AH, Kremers MS, Heidenreich P, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Lang CM, Harder JC, Brindis RG. Review of the registry's first year, data collected, and future plans. Heart Rhythm. 2007 Sep;4(9):1260-3. doi: 10.1016/j.hrthm.2007.07.021. Epub 2007 Jul 25. No abstract available. |
| 18774117 | Background | Hammill SC, Kremers MS, Stevenson LW, Kadish AH, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Curtis JP, Lang CM, Harder JC, Brindis RG. Review of the Registry's second year, data collected, and plans to add lead and pediatric ICD procedures. Heart Rhythm. 2008 Sep;5(9):1359-63. doi: 10.1016/j.hrthm.2008.07.015. Epub 2008 Jul 22. No abstract available. |
| 19716099 | Background | Hammill SC, Kremers MS, Kadish AH, Stevenson LW, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, McKay C, Wang Y, Lang CM, Pontzer K, Rumsfeld J, Phurrough SE, Curtis JP, Brindis RG. Review of the ICD Registry's third year, expansion to include lead data and pediatric ICD procedures, and role for measuring performance. Heart Rhythm. 2009 Sep;6(9):1397-401. doi: 10.1016/j.hrthm.2009.07.015. Epub 2009 Jul 16. No abstract available. |
| 20647056 | Background | Hammill SC, Kremers MS, Stevenson LW, Heidenreich PA, Lang CM, Curtis JP, Wang Y, Berul CI, Kadish AH, Al-Khatib SM, Pina IL, Walsh MN, Mirro MJ, Lindsay BD, Reynolds MR, Pontzer K, Blum L, Masoudi F, Rumsfeld J, Brindis RG. Review of the registry's fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm. 2010 Sep;7(9):1340-5. doi: 10.1016/j.hrthm.2010.07.015. Epub 2010 Jul 18. No abstract available. |
| 18768944 | Background | Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098. |
| 20185109 | Background | Sweeney MO, Sherfesee L, DeGroot PJ, Wathen MS, Wilkoff BL. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Mar;7(3):353-60. doi: 10.1016/j.hrthm.2009.11.027. Epub 2009 Dec 2. |
| 19929037 | Background | Noyes K, Corona E, Veazie P, Dick AW, Zhao H, Moss AJ. Examination of the effect of implantable cardioverter-defibrillators on health-related quality of life: based on results from the Multicenter Automatic Defibrillator Trial-II. Am J Cardiovasc Drugs. 2009;9(6):393-400. doi: 10.2165/11317980-000000000-00000. |
| 2473403 | Background | Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med. 1989 Aug 10;321(6):406-12. doi: 10.1056/NEJM198908103210629. |
| 1900101 | Background | Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21;324(12):781-8. doi: 10.1056/NEJM199103213241201. |
| 1377359 | Background | Cardiac Arrhythmia Suppression Trial II Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med. 1992 Jul 23;327(4):227-33. doi: 10.1056/NEJM199207233270403. |
| 8691967 | Background | Waldo AL, Camm AJ, deRuyter H, Friedman PL, MacNeil DJ, Pauls JF, Pitt B, Pratt CM, Schwartz PJ, Veltri EP. Effect of d-sotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. The SWORD Investigators. Survival With Oral d-Sotalol. Lancet. 1996 Jul 6;348(9019):7-12. doi: 10.1016/s0140-6736(96)02149-6. |
| 19467519 | Background | Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Della Bella P, Hindricks G, Jais P, Josephson ME, Kautzner J, Kay GN, Kuck KH, Lerman BB, Marchlinski F, Reddy V, Schalij MJ, Schilling R, Soejima K, Wilber D; European Heart Rhythm Association (EHRA); Registered Branch of the European Society of Cardiology (ESC); Heart Rhythm Society (HRS); American College of Cardiology (ACC); American Heart Association (AHA). EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European Heart Rhythm Association (EHRA), a Registered Branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm. 2009 Jun;6(6):886-933. doi: 10.1016/j.hrthm.2009.04.030. No abstract available. |
| 8504500 | Background | Grimm W, Flores BT, Marchlinski FE. Shock occurrence and survival in 241 patients with implantable cardioverter-defibrillator therapy. Circulation. 1993 Jun;87(6):1880-8. doi: 10.1161/01.cir.87.6.1880. |
| 11319196 | Background | Exner DV, Pinski SL, Wyse DG, Renfroe EG, Follmann D, Gold M, Beckman KJ, Coromilas J, Lancaster S, Hallstrom AP; AVID Investigators. Antiarrhythmics Versus Implantable Defibrillators. Electrical storm presages nonsudden death: the antiarrhythmics versus implantable defibrillators (AVID) trial. Circulation. 2001 Apr 24;103(16):2066-71. doi: 10.1161/01.cir.103.16.2066. |
| 10369848 | Background | Pacifico A, Hohnloser SH, Williams JH, Tao B, Saksena S, Henry PD, Prystowsky EN. Prevention of implantable-defibrillator shocks by treatment with sotalol. d,l-Sotalol Implantable Cardioverter-Defibrillator Study Group. N Engl J Med. 1999 Jun 17;340(24):1855-62. doi: 10.1056/NEJM199906173402402. |
| 9935007 | Background | Kuhlkamp V, Mewis C, Mermi J, Bosch RF, Seipel L. Suppression of sustained ventricular tachyarrhythmias: a comparison of d,l-sotalol with no antiarrhythmic drug treatment. J Am Coll Cardiol. 1999 Jan;33(1):46-52. doi: 10.1016/s0735-1097(98)00521-x. |
| 9761084 | Background | Seidl K, Hauer B, Schwick NG, Zahn R, Senges J. Comparison of metoprolol and sotalol in preventing ventricular tachyarrhythmias after the implantation of a cardioverter/defibrillator. Am J Cardiol. 1998 Sep 15;82(6):744-8. doi: 10.1016/s0002-9149(98)00478-0. |
| 16403928 | Background | Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165. |
| 16935995 | Background | Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, 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; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Sep 5;114(10):e385-484. doi: 10.1161/CIRCULATIONAHA.106.178233. Epub 2006 Aug 25. No abstract available. |
| 9078197 | Background | Julian DG, Camm AJ, Frangin G, Janse MJ, Munoz A, Schwartz PJ, Simon P. Randomised trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction: EMIAT. European Myocardial Infarct Amiodarone Trial Investigators. Lancet. 1997 Mar 8;349(9053):667-74. doi: 10.1016/s0140-6736(96)09145-3. |
| 9078198 | Background | Cairns JA, Connolly SJ, Roberts R, Gent M. Randomised trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarisations: CAMIAT. Canadian Amiodarone Myocardial Infarction Arrhythmia Trial Investigators. Lancet. 1997 Mar 8;349(9053):675-82. doi: 10.1016/s0140-6736(96)08171-8. |
| 7539890 | Background | Singh SN, Fletcher RD, Fisher SG, Singh BN, Lewis HD, Deedwania PC, Massie BM, Colling C, Lazzeri D. Amiodarone in patients with congestive heart failure and asymptomatic ventricular arrhythmia. Survival Trial of Antiarrhythmic Therapy in Congestive Heart Failure. N Engl J Med. 1995 Jul 13;333(2):77-82. doi: 10.1056/NEJM199507133330201. |
| 6209318 | Background | International mexiletine and placebo antiarrhythmic coronary trial: I. Report on arrhythmia and other findings. Impact Research Group. J Am Coll Cardiol. 1984 Dec;4(6):1148-63. doi: 10.1016/s0735-1097(84)80133-3. |
| 10841242 | Background | Calkins H, Epstein A, Packer D, Arria AM, Hummel J, Gilligan DM, Trusso J, Carlson M, Luceri R, Kopelman H, Wilber D, Wharton JM, Stevenson W. Catheter ablation of ventricular tachycardia in patients with structural heart disease using cooled radiofrequency energy: results of a prospective multicenter study. Cooled RF Multi Center Investigators Group. J Am Coll Cardiol. 2000 Jun;35(7):1905-14. doi: 10.1016/s0735-1097(00)00615-x. |
| 18160685 | Background | Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457. |
| 19064682 | Background | Stevenson WG, Wilber DJ, Natale A, Jackman WM, Marchlinski FE, Talbert T, Gonzalez MD, Worley SJ, Daoud EG, Hwang C, Schuger C, Bump TE, Jazayeri M, Tomassoni GF, Kopelman HA, Soejima K, Nakagawa H; Multicenter Thermocool VT Ablation Trial Investigators. Irrigated radiofrequency catheter ablation guided by electroanatomic mapping for recurrent ventricular tachycardia after myocardial infarction: the multicenter thermocool ventricular tachycardia ablation trial. Circulation. 2008 Dec 16;118(25):2773-82. doi: 10.1161/CIRCULATIONAHA.108.788604. Epub 2008 Dec 8. |
| 20109864 | Background | Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacretaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4. |
| FG001 | Antiarrhythmic Medication | The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. |
| Switched to the Other Arm |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Catheter Ablation | The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults. |
| BG001 | Antiarrhythmic Medication | The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. |
| 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 |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Participants Completed Month 3 Follow-Up | Records participants who completed Month 3 Follow-Up Visit | Number | participants | 3 months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Completed Month 6 Follow-Up | Records participants who completed Month 6 Follow-Up Visit | Number | participants | 6 Months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Had at Least One of the Efficacy Outcome Measurement | Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT) | Number | participants | 6 Months |
| |||||||||||||||||||||||||||||||||
| Secondary | Cardiovascular Hospitalizations | Records participants hospitalized for VT during the study | Number | participants | Baseline, 6 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Remained on Randomized Treatment Assignment | Records participants who only received study treatment as randomized during the entire study | Number | participants | 6 month |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Switched to Other Arm | Records participants who received study treatment as randomized and later switched to other treatment arm during the study | Number | participants | 6 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First Recurrent ICD Therapy for VT | Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT. | Mean | Standard Deviation | Days | Baseline, 6 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Received Treatment Assigned | Records participants who received study randomized treatment during the study | Number | participants | 6 months |
|
Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months
All Serious and non serious adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months. All have been reported in the results.
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 | Catheter Ablation | The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults. | 6 | 13 | 7 | 13 | ||
| EG001 | Antiarrhythmic Medication | The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. | 7 | 14 | 7 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Tachycardia | Cardiac disorders | MedDRA 16.0 |
| ||
| Hematoma | Vascular disorders | MedDRA 16.0 |
| ||
| Cardiac Failure | Cardiac disorders | MedDRA 16.0 |
| ||
| Renal Failure | Renal and urinary disorders | MedDRA 16.0 |
| ||
| Ileus | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Pneumonia | Infections and infestations | MedDRA 16.0 |
| ||
| Device Malfunction | General disorders | MedDRA 16.0 |
| ||
| Aortic Thrombosis | Vascular disorders | MedDRA 16.0 |
| ||
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Chest Pain | General disorders | MedDRA 16.0 |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA 16.0 |
| ||
| Syncope | Nervous system disorders | MedDRA 16.0 |
| ||
| Anemia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 16.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Tachycardia | Cardiac disorders | MedDRA 16.0 |
| ||
| Cardiac Failure | Cardiac disorders | MedDRA 16.0 |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA 16.0 |
| ||
| Hematoma | Vascular disorders | MedDRA 16.0 |
| ||
| Aortic Thrombosis | Vascular disorders | MedDRA 16.0 |
| ||
| Hypotension | Vascular disorders | MedDRA 16.0 |
| ||
| Ileus | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Chest Pain | General disorders | MedDRA 16.0 |
| ||
| Device Malfunction | General disorders | MedDRA 16.0 |
| ||
| Syncope | Nervous system disorders | MedDRA 16.0 |
| ||
| Anemia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Pneumonia | Infections and infestations | MedDRA 16.0 |
| ||
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Renal Failure | Renal and urinary disorders | MedDRA 16.0 |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sana M. Al-Khatib, MD, MHS | Duke Clinical Research Institute | 919-668-8649 | sana.alkhatib@dm.duke.edu |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D013015 | Sotalol |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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