Ventricular TachycardiasPARTITANCT01547208
Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
A study testing Immediate radiofrequency ablation of ventricular tachycardia and Radiofrequency ablation of ventricular tachycardia in people with Ventricular Tachycardias, run by IRCCS San Raffaele at 21 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardias
- What is being tested?
- Immediate radiofrequency ablation of ventricular tachycardia and Radiofrequency ablation of ventricular tachycardia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Sep 2012to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death
Who cannot join
- 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
Trial locations and contacts
21 sites in 7 countries.
Andrea Radinovic contact
Paolo Della Bella contact
21 sites in 7 countries
Italy15 sites, 15 recruiting
- Recruiting
Ospedale S. Donato
Arezzo
Pasquale Notarstefano
Pasquale Notarstefano
- Not yet recruiting
AO Policlinico di Bari
Bari
Giuseppe Grandinetti
Giuseppe Grandinetti
- Recruiting
Ospedale Brotzu
Cagliari
Gianfranco Tola
Gianfranco Tola
- Recruiting
Osp. Fondazione Giovanni Paolo II
Campobasso
Matteo Santamaria
Matteo Santamaria
- Recruiting
Ospedale Mater Domini
Castellanza, Varese
Massimo Tritto
Massimo Tritto
- Recruiting
AO Pugliese Ciaccio
Catanzaro
Giampiero Maglia
Giampiero Maglia
- Recruiting
Ospedale di Desio
Desio, Milan
Giuseppe Mantovani
Giuseppe Mantovani
- Recruiting
Azienda Ospedaliera Sant'Antonio Abate
Gallarate, Varese
Daniela Orsida
Daniela Orsida
- Recruiting
IRCCS San Raffaele
Milan
Andrea Radinovic, radinovic.andrea@hsr.it
Paolo Della bella
- Not yet recruiting
Ospedale di Mirano
Mirano, Venice
Franco Zoppo
Franco Zoppo
- Recruiting
Ospedale di Montebelluna
Montebelluna, Treviso
Diego Vaccari
Diego Vaccari
- Recruiting
Fondazione G. Monasterio
Pisa
Marcello Piacenti
Marcello Piacenti
- Recruiting
Policlinico Casilino
Rome
Alessio Borrelli
Leonardo Calò
- Recruiting
Azienda Ospedaliera Valtellina e Valchiavenna
Sondrio
Maurizio Moizi
Maurizio Moizi
- Recruiting
Ospedale Civile Maggiore
Verona
Giovanni Morani
Giovanni Morani
Belgium1 site, 1 recruiting
- Not yet recruiting
Brussels Heart Center
Brussels
Gaetano Paparella
Gaetano Paparella
Czechia1 site, 1 recruiting
- Not yet recruiting
IKEM Hospital
Prague
Josef Kautzner
Josef Kautzner
France1 site, 1 recruiting
- Recruiting
Hôpital cardiologique du Haut-Lévêque
Bordeaux
Pierre Jais
Pierre Jais
Germany1 site, 1 recruiting
- Recruiting
Herz und Gefass Klinik
Bad Neustadt an der Saale
Thomas Deneke
Thomas Deneke
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria
Lisbon
Luis Carpinteiro
Luis Carpinteiro
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne Hospital
Lausanne
Etienne P Pruvot
Etienne Pruvot
About this study
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.
Read the detailed 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.
- Conditions
- Ventricular Tachycardias
- Being tested
- Immediate radiofrequency ablation of ventricular tachycardia, Radiofrequency ablation of ventricular tachycardia
- Keywords
- ICD shocks, Ventricular tachycardias ablation, Timing of ablation, Electrical storm, Arrhythmic storm
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate radiofrequency ablation of ventricular tachycardiaProcedure or surgery
Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
Radiofrequency ablation of ventricular tachycardiaProcedure or surgery
Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock Receives: Procedure: Immediate radiofrequency ablation of ventricular tachycardia |
| Group B | Active comparator | Patients will wait until an arrhythmic storm to undergo a VT ablation procedure Receives: Procedure: Radiofrequency ablation of ventricular tachycardia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of the first appropriate ICD shock during phase A
Measured: Event Driven
Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B
Measured: Two Years
Secondary outcomes (3)
Number of patients showing cardiac deaths during phase B
Measured: Two Years
Number of patients showing electrical storm (ES) recurrences during phase B
Measured: Two Years
Number of patients showing VT recurrences during phase B
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiasStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Della Bella, IRCCS San Raffaele
- Investigators
- Paolo Della Bella, Study director, IRCCS San RaffaeleAndrea Radinovic, Study director, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547208
- Sponsor's protocol ID
- PARTITA
- Acronym
- PARTITA
- Status last verified
- Apr 2020
- First submitted
- 28 Feb 2012
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18160685Kuck 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.
PubMed 20109864Sweeney 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.
PubMed 20185109Poole 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.
PubMed 18768944Varma 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.
PubMed 20625110Varma 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.
PubMed 20716717Gilliam 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.
PubMed 21627705Carbucicchio 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.
PubMed 18172038Della 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.
PubMed 23439513Vergara 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.
PubMed 22486970Della 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.
PubMed 35369700Kheiri 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.
PubMed 31698933
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
- ClinicalTrials.gov ID
- NCT01547208
- Acronym / sponsor ID
- PARTITA / PARTITA
- Conditions
- Ventricular Tachycardias
- Keywords
- ICD shocks, Ventricular tachycardias ablation, Timing of ablation, Electrical storm, Arrhythmic storm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Immediate radiofrequency ablation of ventricular tachycardiaPatients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock |
| Group B | Active comparator | Procedure: Radiofrequency ablation of ventricular tachycardiaPatients will wait until an arrhythmic storm to undergo a VT ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death
Key exclusion criteria (8 listed)
- General contraindication to transcatheter ablation
- Contraindication to antithrombotic therapy
- Patients chronically treated with class I and III antiarrhythmic drugs
- Patients developing first occurrence of incessant VTs
- Patients receiving a shock for first occurrence of clinically verified ventricular fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate radiofrequency ablation of ventricular tachycardiaRadiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock | Procedure or surgery | Group A |
| Radiofrequency ablation of ventricular tachycardiaRadiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs | Procedure or surgery | Group B |
Primary outcome
Occurrence of the first appropriate ICD shock during phase A
Time frame: Event Driven
Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B
Time frame: Two Years
3 secondary outcomes
Number of patients showing cardiac deaths during phase B
Time frame: Two Years
Number of patients showing electrical storm (ES) recurrences during phase B
Time frame: Two Years
Number of patients showing VT recurrences during phase B
Time frame: Two Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 18160685Reddy 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.
- Background: PubMed 20109864Kuck 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.
- Background: PubMed 20185109Sweeney 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.
- Background: PubMed 18768944Poole 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.
- Background: PubMed 20625110Varma 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.
- Background: PubMed 20716717Varma 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.
- Background: PubMed 21627705Gilliam 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.
- Background: PubMed 18172038Carbucicchio 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.
- Background: PubMed 23439513Della 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.
- Background: PubMed 22486970Vergara 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.
- Derived from this study: PubMed 35369700Della 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.
- Derived from this study: PubMed 31698933Kheiri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Radinovic contact
Paolo Della Bella contact
Paolo Della Bella study director
IRCCS San Raffaele
Andrea Radinovic study director
IRCCS San Raffaele
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate radiofrequency ablation of ventricular tachycardia and Radiofrequency ablation of ventricular tachycardia in people with Ventricular Tachycardias, run by IRCCS San Raffaele at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy, Belgium, Czechia, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Radinovic (radinovic.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of the first appropriate ICD shock during phase A (time frame: Event Driven). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547208, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.