Who are we?


Signup for

Online registration

Log in to register
your trial

Search a trial




van CCT (UK)

van CCT (UK)

Catheter ablation versus Amiodarone to pRevent Future shock Episodes in patients with a defibrillator and a history of a myocardial infarction.

- candidate number6709
- NTR NumberNTR2104
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-nov-2009
- Secondary IDs09.0111 METC
- Public TitleCatheter ablation versus Amiodarone to pRevent Future shock Episodes in patients with a defibrillator and a history of a myocardial infarction.
- Scientific TitleCatheter ablation versus Amiodarone to pRevent Future shock Episodes in patients with a defibrillator and a history of a myocardial infarction.
- hypothesisIt is assumed that recurrence of appropriate ICD shocks is 30% in the Amiodarone group and 16% in the Ablation group.
- Healt Condition(s) or Problem(s) studiedMyocardial infarction, Defibrillation, ICD shock
- Inclusion criteria1. Prior myocardial infarction, at least 3 months ago;
2. ICD implantation for any cause except for: Brugada syndrome, ARVC, HCM, LQTS, SQTS, cathecholaminergic polymorphic VT, other channelopathies;
3. ICD shock for VT of VF without a reversible cause. Reversible causes (must be checked):
A. Acute myocardial ischemia in the following circumstances:
i. Acute coronary syndrome;
ii. Myocardial ischemia as documented by non-invasive myocardial ischemia testing what can be treated by revascularisation.
B. Whenever VT or VF occurs in the setting of antiarrhythmic medication intake (class I or III Vaughn-William) with increased QTc, the patient will not be a candidate for enrolment;
C. High fever (T>39 degrees Celsius) and signs of infection/sepsis at presentation will exclude patient from enrolment;
D. Lead dislocation on X-ray plus signs of mechanical VT induction will exclude patients from the study;
E. Other reversible causes as significant hypoxemia not caused by cardiac failure or known hyperthyroidism. Judgement whether this will be possible cause of VT/VF will be at discretion of the attending physician.

The contribution of electrolyte abnormalities to an episode of unstable VT is notoriously difficult to ascertain, especially if the abnormal electrolyte level is noted after cardiopulmonary resuscitation. In view of this fact, abnormal electrolyte levels will not be used in assessing eligibility for enrolment.

Although volume overload due to heart failure is a possible trigger for VT/VF, it can also be caused by an episode of VT/VF. Therefore, this will not be marked as a reversible cause. If, however, the patient is not successfully treated for the episode of volume overload, he can be excluded from the study. This decision will be at the discretion of the attending physician.

Patients with a cluster of VTs (electrical storm) who require urgent RF ablation are not suitable candidates for our study. Whether these patients require urgent intervention, will be left at the discretion of the investigator. These patients will be registered.

4. Optimal revascularization before ICD implantation performed;
5. Written informed consent.

Patients who meet the inclusion and exclusion criteria and sign the informed consent will be considered enrolled in the study. No patient will be enrolled without an informed consent document signed by the patient. Informed consent forms have to be in compliance with the latest Declaration of Helsinki.
- Exclusion criteria1. Age < 18 years;
2. Use of amiodarone more than 7 days before randomization within the period of 3 months before randomization. If a patient used amiodarone in preceding 3 months, the plasma levels of amiodarone and desethylamiodarone will be determined. If both levels are > 1mg/L the patient will be excluded from the study;
3. Inability to use amiodarone due to past side effects;
4. Class I antiarrythmic drugs not stopped ¡Â 5 times ¨öT prior to randomization;
5. Protruding LV thrombus or cardiac tumor on pre-ablation echocardiogram;
6. Acute myocardial infarction within the preceding 3 months;
7. Non-reversible Class IV NYHA heart failure;
8. Valvular heart disease or mechanical heart valve precluding access to the left ventricle;
9. Unstable coronary artery syndrome or active myocardial infarction;
10. Cardiac surgery within the past 2 months;
11. Mechanical mitral or tricuspid valve prothesis;
12. Serum creatinine > 220 mmol/L (2.5 mg/dL);
13. Thrombocytopenia or coagulopathy;
14. Contraindication to anticoagulation;
15. Stroke within past 30 days;
16. Pregnancy;
17. Acute illness or serious active systemic infection;
18. Other disease process likely to limit survival to less than 12 months;
19. Lack of availability for follow-up.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2009
- planned closingdate1-apr-2012
- Target number of participants238
- InterventionsCatheter ablation or medical therapy with Amiodaron. Both interventions are already used in daily practice, but they have never been compared.
- Primary outcomeTime to recurrence of documented ICD shock therapy for VT of VF during the follow-up period starting post ablation or after receiving amiodarone.
- Secondary outcome1. Total number of ICD shocks during follow-up period;
2. Number of VT’s recorded by the ICD;
3. Quality of life (SF-36 score);
4. Number of hospital readmissions due to a cardiovascular indication;
5. Number of appropriate ICD therapies (including ATP);
6. Number of appropriate ICD shocks;
7. Number of inappropriate ICD therapies (including ATP);
8. Number of inappropriate ICD shocks;
9. Severe clinical events (death, syncope’s, electrical storm episodes (defined as > 3 sustained VT episodes within 24 hours) and cessation of amiodarone due to side-effects).
- TimepointsVisits at: Baseline, 2, 6, 12, 18, 24 and 36 months.
Time to documented ICD shock therapy for VT or VF during the follow up period starting post ablation or after receiving Amiodarone.
- Trial web
- statusstopped
- Sponsor/Initiator Isala Klinieken, Locatie Weezenlanden, Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken, Maatschap Cardiologie
- Publications1. De Bakker JMT, van Capelle FL, Janse MJ et al. Macroreentry in the infarcted human heart: mechanisms of ventricular tachycardia with a focal activation pattern. J Am Coll Cardiol 1991; 18:1005-1014.
2. Pogwidz SM, Hoyt RH, Saffitz JE et al . Reentrant and focal mechanisms underlying ventricular tachycardia in the human heart. Circulation 1992; 86:1872-1887.
3. The Cardiac Arrhythmia Supression Trial (CAST) Investigators. Primary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppresion after myocardial infarction. N Engl J Med 1989; 321:406-412.
4. Horowitz LN, Harken AH, Kastor JA et al. Ventricular resection guided by epicardial and endocardial mapping for treatment of recurrent ventricular tachycardia. N Engl J Med 1980; 302:589-593.
5. Wittig JH, Boineau JP. Surgical treatment of ventricular arrhythmias using epicardial, transmural and endocardial mapping. Ann Thorac Surg 1975; 20:117-126.
6. Bardy GH, Troutman C, Poole JE et al. Clinical experience with a tiered-therapy, multiprogrammable antiarrhythmia device. Circulation 1992; 85:1689-1698.
7. The PCD Investigator Group. Clinical outcome of patients with malignant ventricular tachyarrhythmias and a multiprogrammable implantable cardioverter-defibrillator implanted with or without thoracotomy. An international multicenter study. J Am Coll Cardiol 1994; 1521-1530.
8. The Antiarrhythmics Versus Implantable Defibrillator (AVID) Investigators: A comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med 1997; 337:1576-1583.
9. Kuck KH, Cappato R, Siebels J et al. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest. The Cardiac Arrest Study Hamburg (CASH). Circulation 2000; 102:748-754.
10. Conolly SJ, Gent M, Roberts RS et al. Canadian Implantable Defibrillator Study (CIDS). A randomized trial of the implantable defibrillator against amiodarone. Circulation 2000; 101:1297-1302.
11. 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;346:877-883.
12. 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;352:225-237
13. Gehi AK, Mehta D, Gomes JA. Evaluation and management of patients after implantable cardioverter-defibrillator shock. JAMA 2006;296:2839-2847
14. Groeneveld PW, Matta MA, Suh JJ, Heidenreich PA, Shea JA. Costs and quality-of-life effects of implantable cardioverter-defibrillators. Am J Cardiol 2006;98:1409-1415.
15. Sears SE Jr, Conti JB. Understanding implantable cardioverter defibrillator shocks and storms: medical and psychosocial considerations for research and clinical care. Clin Cardiol 2003;26:107-111.
16. Kamphuis HCM, de Leeuw RJ, Derksen R, Hauer RN, innubst JA. Implantable cardioverter defibrillator recipients: quality of life in recipients with and without ICD shock delivery: a prospective study. Europace 2003;5:381-389.
17. Bilge AK, Ozben B, Demircan S, Cinar M, Yilmaz E, Adalet K. Depression and anxiety status of patients with implantable cardioverter defibrillator and precipitating factors. Pacing Clin Electrophysiol 2006;29:619-626.
18. Villacastín J, Almendral J, Arenal A, et al. Incidence and clinical significance of multiple consecutive, appropriate, highenergy discharges in patients with implanted cardioverter-defibrillators. Circulation1996;93:753-762.
19. Credner SC, Klingenheben T, Mauss O, Sticherling C, Hohnloser SH. Electrical storm in patients with transvenous implantable cardioverter-defibrillators: incidence, management and prognostic implications. J Am Coll Cardiol 1998;32:1909-1915.
20. Stevenson WG, Khan H, Sager PT et al. Identification of reentry circuit sites during catheter mapping and radiofrequency ablation of ventricular tachycardia late after myocardial infarction. Circulation 1993; 88(Part1):1647-1670.
21. Stevenson WG, Friedman PL, Sager PT et al. Exploring postinfarction reentrant ventricular tachycardia with entrainment mapping. J Am Coll Cardiol 1997; 29:1180-1189.
22. Harada T, Kocovic D, Stevenson WG. Electrogram characteristics and late potentials recorded directly from the critical slow conduction zone help to identify target sites during ablation of post infarct ventricular tachycardia. Circulation 1994; 90(No 4, Part 2):I-557A.
23. Stevenson WG, Sager PT, Natterson PD et al. Relation of pace mapping QRS configuration and conduction delay to ventricular tachycardia reentry circuits in human infarct scars. J Am Coll Cardiol 1995; 26:481-488.
24. Strickberger SA, Man C, Daoud EG et al. A prospective evaluation of catheter ablation of ventricular tachycardia as adjuvant therapy in patients with coronary artery disease and an implantable cardioverter-defibrillator. Circulation 1997; 96: 1525-1531.
25. Stevenson WG, Friedman PL, Kocovic D et al. Radiofrequency catheter ablation of ventricular tachycardia after myocardial infarction. Circulation 1998; 98:308-314:
26. Gonska BD, Cao K, Schaumann A et al. Catheter ablation of ventricular tachycardia in 136 patients with coronary artery disease: results and long-term follow up. J Am Coll Cardiol 1994; 24:1506-1514.
27. Morady F, Harvey M, Kalbfleisch SJ et al. Radiofrequency catheter ablation of ventricular tachycardia in patients with coronary artery disease. Circulation 1993; 87:363-372.
28. Wilber D, Kopp D, Glascock D et al. Catheter ablation of the mitral isthmus for ventricular tachycardia associated with inferior infarction. Circulation 1995; 92:3481-3489.
29. Schwartzman D, Jodonrath RL, Callans DJ et al. Radiofrequency catheter ablation for control of frequent ventricular tachycardia with healed myocardial infarction. Am J Cardiol 1995; 75:297-299.
30. El-Shalakany A, Hadjis T, Papageorgiou P et al. Entrainment/Mapping criteria for the prediction of termination of ventricular tachycardia by single radiofrequency lesion in patients with coronary artery disease. Circulation 1999; 99:2283-2289.
31. Kim YH, Sosa-Suarez G, Trouton TG et al. Treatment of ventricular tachycardia by transcatheter radiofrequency ablation in patients with ischemic heart disease. Circulation 1994; 1094-1102.
32. Rothman SA, Hsia HH, Cossu SF, et al. Radiofrequency catheter ablation of postinfarction ventricular tachycardia. Circulation 1997; 96: 3499-3508.
33. Marchlinski FE, Callans DJ, Gottlieb CD et al. Linear ablation lesions for control of unmappable ventricular tachycardia in patients with ischemic and nonischemic cardiomyopathy. Circulation 2000; 101:1288-1296.
34. Furniss S, Anil-Kumar R, Bourke JP et al. Radiofrequency ablation of hemodynamically unstable ventricular tachycardia after myocardial infarction. Heart 2000; 84:648-652.
35. Ellison KE, Stevenson WG, Sweeney MO et al. Catheter ablation for hemodynamically unstable monomorphic ventricular tachycardia. J Cardiovasc Electrophysiol 2000; 11:41-44.
36. Soejima K, Suzuki M, Maisel WH et al. Catheter ablation in patients with multiple and unstable ventricular tachycardias after myocardial infarction. Circulation 2001; 104:664-669.
37. Gepstein L, Evans SJ. Electroanatomical mapping of the heart: basic concepts and implications for the treatment of cardiac arrhythmias. PACE 1998; 21:1268-1278.
38. Gepstein L, Hayam G, Ben-Haim SA. A novel method for nonfluoroscopic catheter based electroanatomical mapping of the heart: in vivo and in vitro accuracy results. Circulation 1997; 95:1611-1622.
39. Shpun S, Gepstein L, Hayam G et al. Guidance of radiofrequency endocardial ablation with real-time three-dimensional magnetic navigation system. Circulation 1997; 96:2016-2021.
40. 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;357:2657-2665.
41. 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;295:165-71
42. Roy D, Marchand E, Theroux P, Waters DD, Pelletier GB, Bourassa MG. Programmed ventricular stimulation in survivors of an acute myocardial infarction. Circulation 1985;72:487-494.
43. Denniss AR, Richards DA, Cody DV, Russell PA, Young AA, Cooper MJ, Ross DL, Uther JB. Prognostic significance of ventricular tachycardia and fibrillation induced at programmed stimulation and delayed potentials detected on the signal-averaged electrocardiograms of survivors of acute myocardial infarction. Circulation 1986;74:731-745.
44. Buxton AE, Fisher JD, Josephson ME, Lee KL, Pryor DB, Prystowsky EN, Simson MB, DiCarlo L, Echt DS, Packer D, et al. Prevention of sudden death in patients with coronary artery disease: the Multicenter Unsustained Tachycardia Trial (MUSTT). Prog Cardiovasc Dis 1993;36:215-226.
45. MO Sweeney, MS. Wathen, K Volosin, I Abdalla, PJ de Groot, MF Otterness, AJ Stark. Appropriate and Inappropriate Ventricular Therapies, Quality of Life, and Mortality Among Primary and Secondary Prevention Implantable Cardioverter Defibrillator Patients: Results From the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) Trial. Circulation 2005;111;2898-2905.
46. Calkins H, Epstein A, Packer D et al. Catheter ablation of ventricular tachycardia in patients with structural heart disease using cooled radiofrequency energy. J Am Coll Cardiol 2000; 35:1905-1914.
47. Snapinn SM. Monitoring clinical trials with a conditional probability stopping rule. Stat Med 1992;11:659-72.
- Brief summaryThe primary purpose of Single-center, prospective, randomized, open trial study is the assessment of recurrences of ICD therapy for VT or VF after appropriate ICD shock therapy in patients with a history of a myocardial infarction undergoing substrate based ablation compared to patients treated with amiodarone alone. Thus the primary purpose is reduction of time to next appropriate ICD shock. It is assumed that recurrence of appropriate ICD shocks is 30% in the Amiodarone group and 16% in the Ablation group.
- Main changes (audit trail)
- RECORD11-nov-2009 - 1-dec-2010

  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar