Ventricular Tachycardias Clinical Trial
— PARTITA| NCT number | NCT01547208 |
| Other study ID # | PARTITA |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2012 |
| Est. completion date | September 2022 |
| Verified date | April 2020 |
| Source | IRCCS San Raffaele |
| Contact | Andrea Radinovic |
| radinovic.andrea[@]hsr.it | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 590 |
| Est. completion date | September 2022 |
| Est. primary completion date | September 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death Exclusion Criteria: Phase A exclusion Criteria: - General contraindication to transcatheter ablation - Contraindication to antithrombotic therapy - Patients chronically treated with class I and III antiarrhythmic drugs Phase B exclusion criteria: - Patients developing first occurrence of incessant VTs - Patients receiving a shock for first occurrence of clinically verified ventricular fibrillation - Patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Brussels Heart Center | Bruxelles | |
| Czechia | IKEM Hospital | Prague | |
| France | Hôpital cardiologique du Haut-Lévêque | Bordeaux | |
| Germany | Herz und Gefass Klinik | Bad Neustadt An Der Saale | |
| Italy | Ospedale S. Donato | Arezzo | |
| Italy | AO Policlinico di Bari | Bari | |
| Italy | Ospedale Brotzu | Cagliari | |
| Italy | Osp. Fondazione Giovanni Paolo II | Campobasso | |
| Italy | Ospedale Mater Domini | Castellanza | Varese |
| Italy | AO Pugliese Ciaccio | Catanzaro | |
| Italy | Ospedale di Desio | Desio | Milan |
| Italy | Azienda Ospedaliera Sant'Antonio Abate | Gallarate | Varese |
| Italy | IRCCS San Raffaele | Milan | |
| Italy | Ospedale di Mirano | Mirano | Venice |
| Italy | Ospedale di Montebelluna | Montebelluna | Treviso |
| Italy | Fondazione G. Monasterio | Pisa | |
| Italy | Policlinico Casilino | Rome | |
| Italy | Azienda Ospedaliera Valtellina e Valchiavenna | Sondrio | |
| Italy | Ospedale Civile Maggiore | Verona | |
| Portugal | Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria | Lisbon | |
| Switzerland | Lausanne Hospital | Lausanne |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS San Raffaele |
Belgium, Czechia, France, Germany, Italy, Portugal, Switzerland,
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. — View Citation
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. — View Citation
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. — View Citation
Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of the first appropriate ICD shock during phase A | Event Driven | ||
| Primary | Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B | Two Years | ||
| Secondary | Number of patients showing cardiac deaths during phase B | Two Years | ||
| Secondary | Number of patients showing electrical storm (ES) recurrences during phase B | Two Years | ||
| Secondary | Number of patients showing VT recurrences during phase B | Two Years |