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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2020
Source IRCCS San Raffaele
Contact Andrea Radinovic
Email radinovic.andrea@hsr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Immediate radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
Radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Italy,  Portugal,  Switzerland, 

References & Publications (10)

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

Outcome

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