Ventricular TachycardiaPhase 3PREVENT-VTNCT04675073
Preventive VT Substrate Ablation in Ischemic Heart Disease
A Phase 3 study testing Ventricular tachycardia substrate-based radiofrequency ablation in people with Ventricular Tachycardia and Ventricular Arrythmia, run by Centro Medico Teknon at 1 site in Spain.
Trial summary
The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Arrythmia, Sudden Cardiac Death
- What is being tested?
- Ventricular tachycardia substrate-based radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to Dec 2025
- Phase
- Phase 3
- 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
- Age > 18 years.
- Chronic, stable ischemic heart disease, irrespectively of the LVEF.
- Life expectancy of > 1 year with a good functional status.
- Documented scar AND a BZC mass > 5.15 g as measured per LGE-CMR and automatic post-processing using the ADAS-3D LV (ADAS 3D Medical SL, Barcelona, Spain).
- Signed informed consent.
Who cannot join
- Age < 18 years.
- Pregnancy.
- Life expectancy of < 1 year, or bad functional status (NYHA IV functional class).
- Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
- Previously documented sustained ventricular arrhythmias.
- Impossibility to perform a contrast-enhanced CMR study.
Show all 9Show fewer
- Calculated BZC mass in the scarred tissue < 5.15 g using the ADAS-3D LV software.
- Concomitant investigation treatments.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro Medico Teknon
Barcelona, 08022
Antonio Berruezo, MD, PhD, +34932906200, antonio.berruezo@quironsalud.es
Antonio Berruezo, MD, PhD
About this study
Official title: Preventive VT Substrate Ablation in Patients With Chronic Post-MI Scar Showing Arrhythmogenic Characteristics
The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.
Read the detailed description
Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (>5% of the LV mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from SMVT than in matched controls for age, sex, infarct location, and LVEF. However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of SCD. (7,8) In a recent, case-control study, the investigators identified the BZC mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain), with FDA 510(k) Clearance and CE Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of time (approx. 2 years).
On the other hand, catheter ablation has become an essential tool in the treatment of ventricular arrhythmias in patients with structural heart disease (SHD). VT ablation techniques have evolved towards substrate-based approaches that permit to abolish multiple VT circuits irrespective of their inducibility or hemodynamic tolerability, improving outcomes with respect to clinical VT ablation. Moreover, VT substrate ablation procedures performed during sinus rhythm and CMR-guided have proven to be safe, with very low procedure related complications.
The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.
- Conditions
- Ventricular Tachycardia, Ventricular Arrythmia, Sudden Cardiac Death, Sudden Cardiac Death Due to Cardiac Arrhythmia, Ischemic Heart Disease, Myocardial Infarction
- Being tested
- Ventricular tachycardia substrate-based radiofrequency ablation
- Keywords
- ventricular tachycardia, ventricular arrhythmia, sudden cardiac death, ischemic heart disease, cardiac magnetic resonance, border zone channels
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular tachycardia substrate-based radiofrequency ablationProcedure or surgery
The CARTO3 electroanatomic navigation system (Biosense Webster, Diamond Bar, CA, USA) will be used for ablation. An open irrigated 3.5-mm tip ablation catheter (ThermoCool SmartTouch, Biosense Webster, Diamond Bar, CA, USA) will be used for mapping and ablation. The first step of the procedure will be the acquisition of a fast-anatomical map (FAM) of the aorta. This FAM will be then used to integrate the multi-detector cardiac tomography (MDCT) reconstruction and cardiac magnetic resonance (CMR)-derived pixel-signal intensity (PSI) maps within the spatial reference coordinates of the CARTO3 system. RF will be delivered at the entrance of the border zone channels (BZCs) identified in the PSI maps (CMR-guided scar dechanneling technique). Programmed ventricular stimulation (PVS) will be always performed after substrate elimination to test for final inducibility.
| Study group | Role | What they receive |
|---|---|---|
| ABLATE arm | Experimental | Ventricular tachycardia substrate ablation intending to: i) eliminate all the potential arrhythmogenic substrate, aiming for complete electrical isolation/elimination of all the electrograms with delayed components or showing hidden slow conduction properties, and ii) non-inducibility or ventricular tachycardias at the end of the procedure. Standard medical treatment will also be given for these patients. Receives: Procedure: Ventricular tachycardia substrate-based radiofrequency ablation |
| NO-TREAT arm | No intervention | Only standard medical treatment will be offered for these patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sudden cardiac death or sustained ventricular tachycardia
Composite outcome of sudden cardiac death or sustained ventricular tachycardia (either treated by an ICD or documented with continuous Holter monitoring) in patients undergoing preventive ventricular tachycardia (VT) substrate ablation vs. standard of care.
Measured: 2 years
Secondary outcomes (6)
Procedure time
Procedure time
Measured: 2 years
Radiofrequency time
Radiofrequency time
Measured: 2 years
Rate of achievement of complete substrate ablation
Rate of achievement of complete substrate ablation
Measured: 2 years
VT inducibility rate
Final VT inducibility rate
Measured: 2 years
Rate of complications
Rate of complications
Measured: 2 years
Rate of need for anti-arrhythmic drugs
Rate of need for anti-arrhythmic drugs in both arms of the study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jun 2021
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
- Investigators
- Antonio Berruezo, MD, PhD, Principal investigator, Centro Médico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675073
- Sponsor's protocol ID
- PREVENT-VT
- Acronym
- PREVENT-VT
- Status last verified
- Aug 2023
- First submitted
- 29 Nov 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Bakker JM, van Capelle FJ, Janse MJ, Wilde AA, Coronel R, Becker AE, Dingemans KP, van Hemel NM, Hauer RN. Reentry as a cause of ventricular tachycardia in patients with chronic ischemic heart disease: electrophysiologic and anatomic correlation. Circulation. 1988 Mar;77(3):589-606. doi: 10.1161/01.cir.77.3.589.
PubMed 3342490Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8. doi: 10.1016/S0140-6736(00)03567-4.
PubMed 11197356Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
PubMed 17389270Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. doi: 10.1161/CIRCULATIONAHA.106.613414. Epub 2006 Jun 26.
PubMed 16801462Klem I, Weinsaft JW, Bahnson TD, Hegland D, Kim HW, Hayes B, Parker MA, Judd RM, Kim RJ. Assessment of myocardial scarring improves risk stratification in patients evaluated for cardiac defibrillator implantation. J Am Coll Cardiol. 2012 Jul 31;60(5):408-20. doi: 10.1016/j.jacc.2012.02.070.
PubMed 22835669Perez-David E, Arenal A, Rubio-Guivernau JL, del Castillo R, Atea L, Arbelo E, Caballero E, Celorrio V, Datino T, Gonzalez-Torrecilla E, Atienza F, Ledesma-Carbayo MJ, Bermejo J, Medina A, Fernandez-Aviles F. Noninvasive identification of ventricular tachycardia-related conducting channels using contrast-enhanced magnetic resonance imaging in patients with chronic myocardial infarction: comparison of signal intensity scar mapping and endocardial voltage mapping. J Am Coll Cardiol. 2011 Jan 11;57(2):184-94. doi: 10.1016/j.jacc.2010.07.043.
PubMed 21211689Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
PubMed 11907286Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
PubMed 15659722Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.
PubMed 27149033Di Biase L, Burkhardt JD, Lakkireddy D, Carbucicchio C, Mohanty S, Mohanty P, Trivedi C, Santangeli P, Bai R, Forleo G, Horton R, Bailey S, Sanchez J, Al-Ahmad A, Hranitzky P, Gallinghouse GJ, Pelargonio G, Hongo RH, Beheiry S, Hao SC, Reddy M, Rossillo A, Themistoclakis S, Dello Russo A, Casella M, Tondo C, Natale A. Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy: The VISTA Randomized Multicenter Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2872-2882. doi: 10.1016/j.jacc.2015.10.026.
PubMed 26718674Soto-Iglesias D, Penela D, Jauregui B, Acosta J, Fernandez-Armenta J, Linhart M, Zucchelli G, Syrovnev V, Zaraket F, Teres C, Perea RJ, Prat-Gonzalez S, Doltra A, Ortiz-Perez JT, Bosch X, Camara O, Berruezo A. Cardiac Magnetic Resonance-Guided Ventricular Tachycardia Substrate Ablation. JACC Clin Electrophysiol. 2020 Apr;6(4):436-447. doi: 10.1016/j.jacep.2019.11.004. Epub 2020 Feb 26.
PubMed 32327078Fernandez-Armenta J, Soto-Iglesias D, Silva E, Penela D, Jauregui B, Linhart M, Bisbal F, Acosta J, Fernandez M, Borras R, Villuendas R, Cano L, Guasch E, Mont L, Berruezo A. Safety and Outcomes of Ventricular Tachycardia Substrate Ablation During Sinus Rhythm: A Prospective Multicenter Registry. JACC Clin Electrophysiol. 2020 Oct 26;6(11):1435-1448. doi: 10.1016/j.jacep.2020.07.028.
PubMed 33121673Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439Andreu D, Ortiz-Perez JT, Fernandez-Armenta J, Guiu E, Acosta J, Prat-Gonzalez S, De Caralt TM, Perea RJ, Garrido C, Mont L, Brugada J, Berruezo A. 3D delayed-enhanced magnetic resonance sequences improve conducting channel delineation prior to ventricular tachycardia ablation. Europace. 2015 Jun;17(6):938-45. doi: 10.1093/europace/euu310. Epub 2015 Jan 23.
PubMed 25616406Andreu D, Berruezo A, Ortiz-Perez JT, Silva E, Mont L, Borras R, de Caralt TM, Perea RJ, Fernandez-Armenta J, Zeljko H, Brugada J. Integration of 3D electroanatomic maps and magnetic resonance scar characterization into the navigation system to guide ventricular tachycardia ablation. Circ Arrhythm Electrophysiol. 2011 Oct;4(5):674-83. doi: 10.1161/CIRCEP.111.961946. Epub 2011 Aug 31.
PubMed 21880674
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive VT Substrate Ablation in Patients With Chronic Post-MI Scar Showing Arrhythmogenic Characteristics
- ClinicalTrials.gov ID
- NCT04675073
- Acronym / sponsor ID
- PREVENT-VT / PREVENT-VT
- Conditions
- Ventricular Tachycardia, Ventricular Arrythmia, Sudden Cardiac Death, Sudden Cardiac Death Due to Cardiac Arrhythmia, Ischemic Heart Disease, Myocardial Infarction
- Keywords
- ventricular tachycardia, ventricular arrhythmia, sudden cardiac death, ischemic heart disease, cardiac magnetic resonance, border zone channels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Dec 2020 (actual)
- 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 investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.
Detailed description
Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (>5% of the LV mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from SMVT than in matched controls for age, sex, infarct location, and LVEF. However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of SCD. (7,8) In a recent, case-control study, the investigators identified the BZC mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain), with FDA 510(k) Clearance and CE Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of time (approx. 2 years).
On the other hand, catheter ablation has become an essential tool in the treatment of ventricular arrhythmias in patients with structural heart disease (SHD). VT ablation techniques have evolved towards substrate-based approaches that permit to abolish multiple VT circuits irrespective of their inducibility or hemodynamic tolerability, improving outcomes with respect to clinical VT ablation. Moreover, VT substrate ablation procedures performed during sinus rhythm and CMR-guided have proven to be safe, with very low procedure related complications.
The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABLATE arm | Experimental | Procedure: Ventricular tachycardia substrate-based radiofrequency ablationVentricular tachycardia substrate ablation intending to: i) eliminate all the potential arrhythmogenic substrate, aiming for complete electrical isolation/elimination of all the electrograms with delayed components or showing hidden slow conduction properties, and ii) non-inducibility or ventricular tachycardias at the end of the procedure. Standard medical treatment will also be given for these patients. |
| NO-TREAT arm | No intervention | –Only standard medical treatment will be offered for these patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- Chronic, stable ischemic heart disease, irrespectively of the LVEF.
- Life expectancy of > 1 year with a good functional status.
- Documented scar AND a BZC mass > 5.15 g as measured per LGE-CMR and automatic post-processing using the ADAS-3D LV (ADAS 3D Medical SL, Barcelona, Spain).
- Signed informed consent.
Key exclusion criteria (9 listed)
- Age < 18 years.
- Pregnancy.
- Life expectancy of < 1 year, or bad functional status (NYHA IV functional class).
- Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
- Previously documented sustained ventricular arrhythmias.
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 |
|---|---|---|
| Ventricular tachycardia substrate-based radiofrequency ablationThe CARTO3 electroanatomic navigation system (Biosense Webster, Diamond Bar, CA, USA) will be used for ablation. An open irrigated 3.5-mm tip ablation catheter (ThermoCool SmartTouch, Biosense Webster, Diamond Bar, CA, USA) will be used for mapping and ablation. The first step of the procedure will be the acquisition of a fast-anatomical map (FAM) of the aorta. This FAM will be then used to integrate the multi-detector cardiac tomography (MDCT) reconstruction and cardiac magnetic resonance (CMR)-derived pixel-signal intensity (PSI) maps within the spatial reference coordinates of the CARTO3 system. RF will be delivered at the entrance of the border zone channels (BZCs) identified in the PSI maps (CMR-guided scar dechanneling technique). Programmed ventricular stimulation (PVS) will be always performed after substrate elimination to test for final inducibility. | Procedure or surgery | ABLATE arm |
Primary outcome
Rate of sudden cardiac death or sustained ventricular tachycardia
Time frame: 2 years
Composite outcome of sudden cardiac death or sustained ventricular tachycardia (either treated by an ICD or documented with continuous Holter monitoring) in patients undergoing preventive ventricular tachycardia (VT) substrate ablation vs. standard of care.
6 secondary outcomes
Procedure time
Time frame: 2 years
Radiofrequency time
Time frame: 2 years
Rate of achievement of complete substrate ablation
Time frame: 2 years
VT inducibility rate
Time frame: 2 years
Rate of complications
Time frame: 2 years
Rate of need for anti-arrhythmic drugs
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 3342490de Bakker JM, van Capelle FJ, Janse MJ, Wilde AA, Coronel R, Becker AE, Dingemans KP, van Hemel NM, Hauer RN. Reentry as a cause of ventricular tachycardia in patients with chronic ischemic heart disease: electrophysiologic and anatomic correlation. Circulation. 1988 Mar;77(3):589-606. doi: 10.1161/01.cir.77.3.589.
- Background: PubMed 11197356Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8. doi: 10.1016/S0140-6736(00)03567-4.
- Background: PubMed 17389270Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
- Background: PubMed 16801462Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. doi: 10.1161/CIRCULATIONAHA.106.613414. Epub 2006 Jun 26.
- Background: PubMed 22835669Klem I, Weinsaft JW, Bahnson TD, Hegland D, Kim HW, Hayes B, Parker MA, Judd RM, Kim RJ. Assessment of myocardial scarring improves risk stratification in patients evaluated for cardiac defibrillator implantation. J Am Coll Cardiol. 2012 Jul 31;60(5):408-20. doi: 10.1016/j.jacc.2012.02.070.
- Background: PubMed 21211689Perez-David E, Arenal A, Rubio-Guivernau JL, del Castillo R, Atea L, Arbelo E, Caballero E, Celorrio V, Datino T, Gonzalez-Torrecilla E, Atienza F, Ledesma-Carbayo MJ, Bermejo J, Medina A, Fernandez-Aviles F. Noninvasive identification of ventricular tachycardia-related conducting channels using contrast-enhanced magnetic resonance imaging in patients with chronic myocardial infarction: comparison of signal intensity scar mapping and endocardial voltage mapping. J Am Coll Cardiol. 2011 Jan 11;57(2):184-94. doi: 10.1016/j.jacc.2010.07.043.
- Background: PubMed 11907286Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
- Background: PubMed 15659722Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
- Background: PubMed 27149033Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.
- Background: PubMed 26718674Di Biase L, Burkhardt JD, Lakkireddy D, Carbucicchio C, Mohanty S, Mohanty P, Trivedi C, Santangeli P, Bai R, Forleo G, Horton R, Bailey S, Sanchez J, Al-Ahmad A, Hranitzky P, Gallinghouse GJ, Pelargonio G, Hongo RH, Beheiry S, Hao SC, Reddy M, Rossillo A, Themistoclakis S, Dello Russo A, Casella M, Tondo C, Natale A. Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy: The VISTA Randomized Multicenter Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2872-2882. doi: 10.1016/j.jacc.2015.10.026.
- Background: PubMed 32327078Soto-Iglesias D, Penela D, Jauregui B, Acosta J, Fernandez-Armenta J, Linhart M, Zucchelli G, Syrovnev V, Zaraket F, Teres C, Perea RJ, Prat-Gonzalez S, Doltra A, Ortiz-Perez JT, Bosch X, Camara O, Berruezo A. Cardiac Magnetic Resonance-Guided Ventricular Tachycardia Substrate Ablation. JACC Clin Electrophysiol. 2020 Apr;6(4):436-447. doi: 10.1016/j.jacep.2019.11.004. Epub 2020 Feb 26.
- Background: PubMed 33121673Fernandez-Armenta J, Soto-Iglesias D, Silva E, Penela D, Jauregui B, Linhart M, Bisbal F, Acosta J, Fernandez M, Borras R, Villuendas R, Cano L, Guasch E, Mont L, Berruezo A. Safety and Outcomes of Ventricular Tachycardia Substrate Ablation During Sinus Rhythm: A Prospective Multicenter Registry. JACC Clin Electrophysiol. 2020 Oct 26;6(11):1435-1448. doi: 10.1016/j.jacep.2020.07.028.
- Individual participant dataSharing planned: No
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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.
Antonio Berruezo, MD, PhD principal investigator
Centro Médico Teknon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ventricular tachycardia substrate-based radiofrequency ablation in people with Ventricular Tachycardia and Ventricular Arrythmia, run by Centro Medico Teknon at 1 site in Spain.
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 5 inclusion and 9 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Antonio Berruezo, MD, PhD ((+34) 93 290 62 51, antonio.berruezo@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sudden cardiac death or sustained ventricular tachycardia (time frame: 2 years). 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 NCT04675073, which also lists 21 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 30 Aug 2023.