NCT01547208

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
7 countries

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

10 years

First QC Date

February 28, 2012

Last Update Submit

April 12, 2020

Conditions

Ventricular Tachycardias

Keywords

ICD shocksVentricular tachycardias ablationTiming of ablationElectrical stormArrhythmic storm

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • 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

    Two Years

Study Arms (2)

Group A

EXPERIMENTAL

Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock

Procedure: Immediate radiofrequency ablation of ventricular tachycardia

Group B

ACTIVE COMPARATOR

Patients will wait until an arrhythmic storm to undergo a VT ablation procedure

Procedure: Radiofrequency ablation of ventricular tachycardia

Interventions

Immediate radiofrequency ablation of ventricular tachycardiaPROCEDURE

Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock

Group A
Radiofrequency ablation of ventricular tachycardiaPROCEDURE

Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death

You may not qualify if:

  • 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
  • Patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Brussels Heart Center

Brussels, Belgium

NOT YET RECRUITING

IKEM Hospital

Prague, Czechia

NOT YET RECRUITING

Hôpital cardiologique du Haut-Lévêque

Bordeaux, France

RECRUITING

Herz und Gefass Klinik

Bad Neustadt an der Saale, Germany

RECRUITING

Ospedale di Desio

Desio, Milan, Italy

RECRUITING

Ospedale di Montebelluna

Montebelluna, Treviso, Italy

RECRUITING

Ospedale Mater Domini

Castellanza, Varese, Italy

RECRUITING

Azienda Ospedaliera Sant'Antonio Abate

Gallarate, Varese, Italy

RECRUITING

Ospedale di Mirano

Mirano, Venice, Italy

NOT YET RECRUITING

Ospedale S. Donato

Arezzo, Italy

RECRUITING

AO Policlinico di Bari

Bari, Italy

NOT YET RECRUITING

Ospedale Brotzu

Cagliari, Italy

RECRUITING

Osp. Fondazione Giovanni Paolo II

Campobasso, Italy

RECRUITING

AO Pugliese Ciaccio

Catanzaro, Italy

RECRUITING

IRCCS San Raffaele

Milan, Italy

RECRUITING

Fondazione G. Monasterio

Pisa, Italy

RECRUITING

Policlinico Casilino

Rome, Italy

RECRUITING

Azienda Ospedaliera Valtellina e Valchiavenna

Sondrio, Italy

RECRUITING

Ospedale Civile Maggiore

Verona, Italy

RECRUITING

Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria

Lisbon, Portugal

RECRUITING

Lausanne Hospital

Lausanne, Switzerland

RECRUITING

Related Publications (12)

  • 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.

    PMID: 18160685BACKGROUND

  • 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.

    PMID: 20109864BACKGROUND

  • 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.

    PMID: 20185109BACKGROUND

  • 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.

    PMID: 18768944BACKGROUND

  • 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.

    PMID: 20625110BACKGROUND

  • 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.

    PMID: 20716717BACKGROUND

  • 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.

    PMID: 21627705BACKGROUND

  • 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.

    PMID: 18172038BACKGROUND

  • 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.

    PMID: 23439513BACKGROUND

  • 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.

    PMID: 22486970BACKGROUND

  • 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.

    PMID: 35369700DERIVED

  • 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.

    PMID: 31698933DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paolo Della Bella

    IRCCS San Raffaele

    STUDY DIRECTOR

  • Andrea Radinovic

    IRCCS San Raffaele

    STUDY DIRECTOR

Central Study Contacts

Andrea Radinovic

CONTACT

radinovic.andrea@hsr.it

Paolo Della Bella

CONTACT

dellabella.paolo@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Arrhythmia Department and Clinical Electrophysiology Laboratories

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 7, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

BE(1)FR(1)IT(15)CH(1)CZ(1)DE(1)PT(1)