Vintage (navigation intramyocardique ventriculaire pour ablation tachycardie guidée par des électrogrammes) utilisant des cathéters commerciaux standard (COTS), étude de faisabilité précoce
Background:
Ventricular arrhythmia is an abnormal pulse rhythm that starts in the lower part of the heart (ventricles). Treatment includes ablation; ablation uses heat to destroy small portions of the heart that are causing short circuits in the normal heartbeats. But ablation does not always work well because some parts of the heart are hard to reach with current tools. Researchers want to try a new method called VINTAGE (ventricular intramyocardial navigation for tachycardia ablation guided by electrograms). VINTAGE may be better able to treat portions of the heart that are harder to reach with standard techniques.
Objective:
To test VINTAGE in people with ventricular arrhythmia.
Eligibility:
People aged 21 years and older with ventricular arrhythmia that did not respond to standard treatment.
Design:
Participants will have baseline tests. They will have blood tests and tests of their heart function. They will have imaging scans. They will complete a health questionnaire.
Participants will undergo the VINTAGE procedure. They will be either completely or partially asleep. Doctors will insert tubes through large blood vessels in the groin. Tubes may also be inserted through the chest and wrist. They will use x-rays and ultrasound to guide tubes and guidewires directly into the heart muscle to do the ablation.
Participants will stay in the hospital 1 or more nights after the procedure.
Participants will have 3 follow-up visits over 6 months. These visits are for standard care after heart ablation. They will include blood tests, imaging scans, and tests of heart function. Participants may also wear a device to monitor their heart rhythms at home.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Ventricular arrhythmias cause heart damage or death. Ventricular arrhythmias usually arise from small zones of the heart that contribute a short circuit or errant stimulus. Ventricular arrhythmias may be reduced or abolished by non-surgical catheter procedures to heat and destroy the small portions of the heart that contribute a short circuit or abnormal pacemaker. However, not all portions of the heart can physically be reached for catheter treatment.
We have developed a new non-surgical catheter approach called VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) to treat ventricular arrhythmias arising from difficult-to-reach portions of the heart. In VINTAGE, catheter tools are moved inside the walls of the beating heart to reach treatment targets. In a small number of patients who failed prior catheter treatment of ventricular arrhythmia, VINTAGE effectively suppressed the ventricular arrhythmia or abnormal pacemaker in most.
The purpose of this research protocol is to test VINTAGE more carefully in people with ventricular arrhythmias who have failed prior catheter ablation. In this protocol, we will use catheter tools that are commercially available but are not designed or approved for use in VINTAGE.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30322-1102
- Emory University Hospital Midtown
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
- INCLUSION CRITERIA:
Candidates must meet all of the following criteria:
-
Age >= 21 years
-
Undergoing planned repeat radiofrequency catheter ablation for ventricular arrhythmias (Having failed a previous attempt at catheter ablation and at least one antiarrhythmic drug for ventricular arrhythmias)
-
Ventricular arrhythmia COHORT 1:
- Monomorphic ventricular tachycardia
- Has an implanted cardioverter defibrillator (ICD)
- Hospital admission for ventricular tachycardia since most recent ablation attempt
-
Ventricular arrhythmia COHORT 2:
--Monomorphic (unifocal), frequent, premature ventricular contraction, >=15% burden
-
Either of
- Symptomatic (intolerable palpitation, syncope, fatigue, dyspnea, heart failure, hospital admission for ventricular arrhythmia, appropriate ICD discharge, appropriate antitachycardia pacing), OR
- Left ventricular ejection fraction < 0.50
-
Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing
EXCLUSION CRITERIA:
- Does not consent to participate, or unable to consent to participate
- Left ventricular ejection fraction < 0.20
- Hemodynamic instability or emergency procedure
- Requires planned temporary mechanical circulatory device (such as percutaneous left ventricular assist device or intraaortic balloon counterpulsation pump)
- Pregnant
- eGFR < 30 mL/min/1.73m^2 or end-stage renal failure requiring renal replacement therapy
- Survival despite successful procedure expected < 6 mo
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: VINTAGE Arm
Non-surgical catheter approach called VINTAGE will be used to treat ventricular arrhythmias arising from difficult-to-reach portions of the heart. |
Non-surgical catheter approach called VINTAGE will be used to treat ventricular arrhythmias arising from difficult-to-reach portions of the heart. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
VT COHORT: Freedom from appropriate implanted cardioverter-defibrillator (ICD) shocks or hospital admission due to recurrent VT
Délai: 6 months
|
The primary endpoint for VT Cohort is freedom from appropriate implanted cardioverter-defibrillator (ICD) shocks or hospital admission due to recurrent VT at 6 months. |
6 months
|
|
PVC COHORT: Reduction in PVC burden
Délai: 6 months
|
The primary endpoint for participants treated for PVC Cohort is reduction in PVC burden at 6 months. |
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Freedom from major adverse cardiovascular events
Délai: Time of discharge
|
The secondary endpoint is freedom from major adverse cardiovascular events at the time of discharge from the index VINTAGE procedure. This excludes VINTAGE-related pericarditis and pericardial effusion not requiring secondary intervention. |
Time of discharge
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Robert J Lederman, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 10002320
- 002320-H
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
IPD that underline results in a publication will be shared. Medical images will not be shared because of intrinsic inability to protect confidentiality with reasonable effort.
Délai de partage IPD
Data will be made available by the end of the project or protocol or at the time of associated publication.
Critères d'accès au partage IPD
BioData Catalyst is supported by NHLBI and access to data is controlled by the NHLBI Data Access Committee (DAC) utilizing the database of Genotypes and Phenotypes (dbGaP) permissions infrastructure. In order to access controlled-access data in BioData Catalyst, an investigator must have an approved Data Access Request (DAR) in dbGaP.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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