Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia (UNITE-VT)
Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia: a UK Randomised Controlled Trial
Ventricular tachycardia (VT) is an abnormal and dangerous heart rhythm affecting the lower chambers of the heart (the ventricles). Patients with structural heart disease caused by previous heart attacks are at an increased risk of developing VT. Current guidelines recommend that patients who develop this abnormal heart rhythm are considered for invasive catheter ablation (ICA). This is an invasive procedure where specialised catheters and a 3D electro anatomical mapping (EAM) system are used to identify the region of the heart responsible for the VT, which is then treated by tissue heating or freezing (ablation). Although significant improvements have been made in both mapping and ablation technologies, these procedures remain technically challenging and time consuming.
View into ventricular onset (VIVO, Catheter Precision) is a non-invasive, mapping system already being used within the NHS. It uses images from previous heart scans, a picture of the patient's chest (taken at the start of the procedure) and a 12-lead electrocardiogram (ECG) tracing, to locate where the VT is coming from. The VIVO map can therefore highlight the likely region of interest for ICA prior to invasive EAM.
This study will be a prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT). Patients will be evenly randomised (50:50) into a standard VT ablation group and a VIVO guided ablation group. In the VIVO guided ablation group, invasive EAM will be restricted to the region of interest identified using the VIVO map, rather than whole chamber mapping required for standard ablation. The primary objective will be to determine if the VIVO non-invasive mapping system reduces procedure duration and therefore improves workflow efficiency. Secondary objectives will assess the procedural success, safety and patient perceived health benefits of a VIVO guided ablation versus standard ablation.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Brighton, Vereinigtes Königreich, BN2 1ES
- Noch keine Rekrutierung
- Royal Sussex County Hospital
-
Kontakt:
- John Silberbauer, Dr.
- Telefonnummer: 01273 664943
- E-Mail: john.silberbauer@nhs.net
-
Coventry, Vereinigtes Königreich, CV2 2DX
- Rekrutierung
- University Hospitals Coventry and Warwickshire
-
Kontakt:
- Tarv Dhanjal, Dr.
- Telefonnummer: 02476 966400
- E-Mail: Tarv.Dhanjal@uhcw.nhs.uk
-
Kontakt:
- Jaffar Al-Sheikhli, Dr.
- Telefonnummer: 024 7696 2415
- E-Mail: Jaffar.Al-Sheikhli@uhcw.nhs.uk
-
Middlesbrough, Vereinigtes Königreich, TS4 3B
- Rekrutierung
- The James Cook University Hospital
-
Kontakt:
- Matthew Bates, Dr.
- Telefonnummer: 58229 01642 858229
- E-Mail: matthew.bates1@nhs.net
-
Kontakt:
- Simon James, Dr.
- E-Mail: simon.james1@nhs.net
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- ≥18 years old
Patient with the following:
- Evidence of post-myocardial infarction* structural heart disease.
- Cardiac CT and/or cardiac MRI scan performed within 6 months.
- ICD/CRTD implantation.
- Device therapy for VT: at least 1 appropriate ICD shock or 3 ATP episodes within a 6-month period.
- Suitable candidate for VT ablation as per NHS standard of care.
- Patient agrees to comply with study procedures and be available for routine follow up visits for at least 6 months after enrolment.
Exclusion Criteria:
- Lacks capacity to provide informed consent.
- Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
- Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
- Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.
- Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the patient or deem the patient inappropriate to participate in the study.
- Known allergies or intolerance to AADs to be used to treat PVCs.
- Known allergy for contrast.
- Female patients who are pregnant or breast feeding.
- Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem them inappropriate to participate in this study.
- Other conditions that may prevent patients from adhering to the study protocol, in the opinion of the investigator.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: VIVO-assisted VT ablation
|
VIVO (or View Into Ventricular Onset) is a non-invasive cardiac mapping technology which uses images from patients' previous heart scans, a picture of their chest (taken at the start of the procedure) and a tracing of their VT, to locate where the ventricular tachycardia is coming from.
|
|
Kein Eingriff: Standard VT Ablation
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total procedural time (minutes)
Zeitfenster: day of procedure
|
the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
|
day of procedure
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Procedure time in VT (minutes)
Zeitfenster: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Mapping time (minutes)
Zeitfenster: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Ablation time (minutes).
Zeitfenster: During VT ablation procedure
|
During VT ablation procedure
|
|
|
Total number of ablation applications
Zeitfenster: During ablation procedure
|
During ablation procedure
|
|
|
Total number of shocks delivered
Zeitfenster: during the VT ablation procedure
|
during the VT ablation procedure
|
|
|
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Zeitfenster: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Number of Participants with substrate modification confirmed by remap
Zeitfenster: during the VT ablation procedure
|
during the VT ablation procedure
|
|
|
Total number of ICD/CRTD determined appropriate shock events
Zeitfenster: day of procedure to 6 months post-procedure
|
Total number of ICD/CRTD shock events per patient will be documented on database
|
day of procedure to 6 months post-procedure
|
|
Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events
Zeitfenster: day of procedure to 6 months post-procedure
|
Total number of ICD/CRTD ATP events per patient will be documented on database
|
day of procedure to 6 months post-procedure
|
|
Total number of VT episodes as determined from ICD/CRTD
Zeitfenster: day of procedure to 6 months post-procedure
|
day of procedure to 6 months post-procedure
|
|
|
Recognised VT ablation procedural complications
Zeitfenster: day of the procedure to 30 days after the VT ablation procedure
|
day of the procedure to 30 days after the VT ablation procedure
|
|
|
Total number of hospitalisations
Zeitfenster: day of the procedure to 30 days after the VT ablation procedure
|
Total number of hospitalisation events per patient will be documented on database
|
day of the procedure to 30 days after the VT ablation procedure
|
|
Mortality
Zeitfenster: day of the procedure to 30 days after the VT ablation procedure
|
day of the procedure to 30 days after the VT ablation procedure
|
|
|
Perceived health benefit of treatment
Zeitfenster: at baseline and 6 months
|
EQ-5D-5L
|
at baseline and 6 months
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TD660525
- SOC.12/24-25 (Andere Kennung: University of Warwick)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .