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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Brighton, Zjednoczone Królestwo, BN2 1ES
- Jeszcze nie rekrutacja
- Royal Sussex County Hospital
-
Kontakt:
- John Silberbauer, Dr.
- Numer telefonu: 01273 664943
- E-mail: john.silberbauer@nhs.net
-
Coventry, Zjednoczone Królestwo, CV2 2DX
- Rekrutacyjny
- University Hospitals Coventry and Warwickshire
-
Kontakt:
- Tarv Dhanjal, Dr.
- Numer telefonu: 02476 966400
- E-mail: Tarv.Dhanjal@uhcw.nhs.uk
-
Kontakt:
- Jaffar Al-Sheikhli, Dr.
- Numer telefonu: 024 7696 2415
- E-mail: Jaffar.Al-Sheikhli@uhcw.nhs.uk
-
Middlesbrough, Zjednoczone Królestwo, TS4 3B
- Rekrutacyjny
- The James Cook University Hospital
-
Kontakt:
- Matthew Bates, Dr.
- Numer telefonu: 58229 01642 858229
- E-mail: matthew.bates1@nhs.net
-
Kontakt:
- Simon James, Dr.
- E-mail: simon.james1@nhs.net
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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.
|
|
Brak interwencji: Standard VT Ablation
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Total procedural time (minutes)
Ramy czasowe: day of procedure
|
the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
|
day of procedure
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Procedure time in VT (minutes)
Ramy czasowe: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Mapping time (minutes)
Ramy czasowe: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Ablation time (minutes).
Ramy czasowe: During VT ablation procedure
|
During VT ablation procedure
|
|
|
Total number of ablation applications
Ramy czasowe: During ablation procedure
|
During ablation procedure
|
|
|
Total number of shocks delivered
Ramy czasowe: during the VT ablation procedure
|
during the VT ablation procedure
|
|
|
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Ramy czasowe: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Number of Participants with substrate modification confirmed by remap
Ramy czasowe: during the VT ablation procedure
|
during the VT ablation procedure
|
|
|
Total number of ICD/CRTD determined appropriate shock events
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: day of procedure to 6 months post-procedure
|
day of procedure to 6 months post-procedure
|
|
|
Recognised VT ablation procedural complications
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: at baseline and 6 months
|
EQ-5D-5L
|
at baseline and 6 months
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TD660525
- SOC.12/24-25 (Inny identyfikator: University of Warwick)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .