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The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.
Enrolled patients will remain in a first phase of the study until the first appropriate ICD shock will be delivered.
The objective of this first stage is to assess whether the burden of untreated non sustained VTs or episodes treated with anti-tachycardia pacing is predictive of appropriate ICD shocks.
The second phase of the study will start after the first appropriate ICD shock delivered for VT.
Patients will be then randomized to immediate VT ablation or to standard treatment, meaning waiting until next arrhythmic storm to perform a VT ablation procedure.
The objective of this phase is compare the rate of worsening heart failure hospitalizations and deaths from any cause between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock |
|
| Group B | Active Comparator | Patients will wait until an arrhythmic storm to undergo a VT ablation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate radiofrequency ablation of ventricular tachycardia | Procedure | Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of the first appropriate ICD shock during phase A | Event Driven | |
| Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B | Two Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients showing cardiac deaths during phase B | Two Years | |
| Number of patients showing electrical storm (ES) recurrences during phase B | Two Years | |
| Number of patients showing VT recurrences during phase B |
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Inclusion Criteria:
Exclusion Criteria:
Phase A exclusion Criteria:
Phase B exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Radinovic | Contact | radinovic.andrea@hsr.it | ||
| Paolo Della Bella | Contact | dellabella.paolo@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Della Bella | IRCCS San Raffaele | Study Director |
| Andrea Radinovic | IRCCS San Raffaele | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels Heart Center | Not yet recruiting | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 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. |
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| Radiofrequency ablation of ventricular tachycardia | Procedure | Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs |
|
| Two Years |
| IKEM Hospital | Not yet recruiting | Prague | Czechia |
|
| Hôpital cardiologique du Haut-Lévêque | Recruiting | Bordeaux | France |
|
| Herz und Gefass Klinik | Recruiting | Bad Neustadt an der Saale | Germany |
|
| Ospedale di Desio | Recruiting | Desio | Milan | Italy |
|
| Ospedale di Montebelluna | Recruiting | Montebelluna | Treviso | Italy |
|
| Ospedale Mater Domini | Recruiting | Castellanza | Varese | Italy |
|
| Azienda Ospedaliera Sant'Antonio Abate | Recruiting | Gallarate | Varese | Italy |
|
| Ospedale di Mirano | Not yet recruiting | Mirano | Venice | Italy |
|
| Ospedale S. Donato | Recruiting | Arezzo | Italy |
|
| AO Policlinico di Bari | Not yet recruiting | Bari | Italy |
|
| Ospedale Brotzu | Recruiting | Cagliari | Italy |
|
| Osp. Fondazione Giovanni Paolo II | Recruiting | Campobasso | Italy |
|
| AO Pugliese Ciaccio | Recruiting | Catanzaro | Italy |
|
| IRCCS San Raffaele | Recruiting | Milan | Italy |
|
| Fondazione G. Monasterio | Recruiting | Pisa | Italy |
|
| Policlinico Casilino | Recruiting | Rome | Italy |
|
| Azienda Ospedaliera Valtellina e Valchiavenna | Recruiting | Sondrio | Italy |
|
| Ospedale Civile Maggiore | Recruiting | Verona | Italy |
|
| Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria | Recruiting | Lisbon | Portugal |
|
| Lausanne Hospital | Recruiting | Lausanne | Switzerland |
|
| 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. |
| 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. |
| 20625110 | Background | Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12. |
| 20716717 | Background | Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17. |
| 21627705 | Background | Gilliam FR, Hayes DL, Boehmer JP, Day J, Heidenreich PA, Seth M, Jones PW, Stein KM, Saxon LA. Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study. J Cardiovasc Electrophysiol. 2011 Sep;22(9):1023-9. doi: 10.1111/j.1540-8167.2011.02086.x. Epub 2011 May 31. |
| 18172038 | Background | Carbucicchio C, Santamaria M, Trevisi N, Maccabelli G, Giraldi F, Fassini G, Riva S, Moltrasio M, Cireddu M, Veglia F, Della Bella P. Catheter ablation for the treatment of electrical storm in patients with implantable cardioverter-defibrillators: short- and long-term outcomes in a prospective single-center study. Circulation. 2008 Jan 29;117(4):462-9. doi: 10.1161/CIRCULATIONAHA.106.686534. Epub 2008 Jan 2. |
| 23439513 | Background | Della Bella P, Baratto F, Tsiachris D, Trevisi N, Vergara P, Bisceglia C, Petracca F, Carbucicchio C, Benussi S, Maisano F, Alfieri O, Pappalardo F, Zangrillo A, Maccabelli G. Management of ventricular tachycardia in the setting of a dedicated unit for the treatment of complex ventricular arrhythmias: long-term outcome after ablation. Circulation. 2013 Apr 2;127(13):1359-68. doi: 10.1161/CIRCULATIONAHA.112.000872. Epub 2013 Feb 25. |
| 22486970 | Background | Vergara P, Trevisi N, Ricco A, Petracca F, Baratto F, Cireddu M, Bisceglia C, Maccabelli G, Della Bella P. Late potentials abolition as an additional technique for reduction of arrhythmia recurrence in scar related ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2012 Jun;23(6):621-7. doi: 10.1111/j.1540-8167.2011.02246.x. Epub 2012 Apr 4. |
| 35369700 | Derived | Della Bella P, Baratto F, Vergara P, Bertocchi P, Santamaria M, Notarstefano P, Calo L, Orsida D, Tomasi L, Piacenti M, Sangiorgio S, Pentimalli F, Pruvot E, De Sousa J, Sacher F, Tritto M, Rebellato L, Deneke T, Romano SA, Nesti M, Gargaro A, Giacopelli D, Peretto G, Radinovic A. Does Timing of Ventricular Tachycardia Ablation Affect Prognosis in Patients With an Implantable Cardioverter Defibrillator? Results From the Multicenter Randomized PARTITA Trial. Circulation. 2022 Jun 21;145(25):1829-1838. doi: 10.1161/CIRCULATIONAHA.122.059598. Epub 2022 Apr 3. |
| 31698933 | Derived | Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8. |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| 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 |
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