Targeted Ablation to Isolate Scar Channels Causing Ventricular Tachycardia
8. september 2026 opdateret af: New York Medical College
Segmental Substrate Isolation for the Treatment of Ventricular Tachycardia in Patients With Structural Heart Disease
The goal of this study is to map conducting channels within scar that cause ventricular tachycardia (VT) in patients with scar in their hearts in order to block these channels from causing VT with targeted radiofrequency ablation (cautery).
Participants undergoing VT ablation mapping of these channels by pacing many sites within the scar area and determining where these channels exit the scar into normal tissue. These exits will be ablated. Immediate success and success at 1 year will be evaluated.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
After standard VT induction and mapping procedures (noninvasive identification of induced VT exit sites with Vektor vMap; substrate mapping; initial pacemapping), the study will consist of pacing within the substrate and mapping all channel exits both noninvasively with vMap as well as invasively with high density mapping catheters within the heart by escape mapping (all paced sites creating a consistent paced morphology, up to the shortest stimulus-to-QRS interval achieved) as well as focal activation mapping of this channel exit while pacing within the channel.
The noninvasive map will aid in focusing invasive mapping to a small area of the substrate.
Once the exit sites are determined, ablation energy will be delivered based on the mapped exit sites in the substrate channel within 0.5cm of the exit with the goal of blocking each exit site mapped.
After the ablation lesion set is delivered, repeat attempt to induce VT will be performed.
If more VT is induced, additional ablation energy will be delivered guided by standard mapping techniques (substrate, slow conduction zones, pacemapping).
Undersøgelsestype
Observationel
Tilmelding (Anslået)
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Valhalla, New York, Forenede Stater, 10595
- Rekruttering
- Westchester Medical Center
-
Underforsker:
- Daniel Frenkel, MD
-
Kontakt:
- Jason T Jacobson, MD
- Telefonnummer: 9144935314
- E-mail: Jason.Jacobson@wmchealth.org
-
Kontakt:
- Sei Iwai, MD
- Telefonnummer: 9149096900
- E-mail: Sei.Iwai@wmchealth.org
-
Ledende efterforsker:
- Jason Jacobson, MD
-
Underforsker:
- Sei Iwai, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients presenting to Westchester medical Center for ablation of VT with structural heart disease
Beskrivelse
Inclusion Criteria:
- Patients with structural heart disease undergoing VT ablation
Exclusion Criteria:
- Unable or unwilling to sign consent
- Cardiogenic shock or NYHA Class IV heart failure and not a candidate for mechanical circulatory support for the procedure (percutaneous left ventricular assist device (LVAD), extracorporeal membrane oxygenation, or implanted LVAD)
- Absence of substrate during initial voltage mapping
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants achieving substrate Isolation with ablation of exit sites
Tidsramme: Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.
|
Inability to stimulate the ventricle (physiologic parameter) while pacing in the substrate area contained by the ablation lines through each pacemap exit, at sites that were able to stimulate the ventricle prior to ablation.
This will be manifest by the absence of a QRS complex resultant from the pacing stimulus.
This is a
|
Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
VT invasive map exit and vMap exit match
Tidsramme: Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
|
Percent matching of VT exits determined by activation/entrainment/pace mapping for matched ECG morphologies with vMap determined exits
|
Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
|
|
Channel exit and vMap match
Tidsramme: Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
|
Percent matching of noninvasively mapped exit sites compared with invasively mapped channel exits
|
Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
|
|
Inducibility post initial ablation
Tidsramme: Perioperative/Periprocedural: This will be measured during the study ablation procedure, after the first set of radiofrequency lesions is placed based in initial mapping.
|
VT inducibility after first lesion sets determined by channel mapping
|
Perioperative/Periprocedural: This will be measured during the study ablation procedure, after the first set of radiofrequency lesions is placed based in initial mapping.
|
|
1 year outcome
Tidsramme: 1 year: This will be measured for each subject up to 1 year after the study procedure.
|
VT recurrence at 1 year determined by therapies delivered by implantable cardioverted defibrillator and presentation with sustained VT below ICD detection.
|
1 year: This will be measured for each subject up to 1 year after the study procedure.
|
Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. marts 2025
Primær færdiggørelse (Anslået)
9. december 2027
Studieafslutning (Anslået)
9. december 2028
Datoer for studieregistrering
Først indsendt
17. juni 2025
Først indsendt, der opfyldte QC-kriterier
8. september 2026
Først opslået (Faktiske)
10. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23989
Plan for individuelle deltagerdata (IPD)
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