Dipole Density Mapping in Supraventricular Tachycardia (DDRAMATIC-SVT)
Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:
NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, & Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)
All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Hamburg, Allemagne, D - 20246
- Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
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Bruges, Belgique, 8000
- AZ Sint-Jan AV Cardiologie
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Ontario
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Newmarket, Ontario, Canada, L3Y 2P9
- Southlake Regional Health Center
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Santiago, Chili, Región Metropolitana
- Pontificia Universidad Catolica de Chile
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Cambridge, Royaume-Uni, CB23
- Papworth Hospital NHS Foundation Trust
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Liverpool, Royaume-Uni, L14 3PE
- Liverpool Heart and Chest Hospital
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Whitechapel, Royaume-Uni, E1 1BB
- Barts Health NHS Trust
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Prague, Tchéquie, 150 30
- Na Homolce Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria
- Be aged 18-75 years
- Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
- Be able and willing to give informed consent
Exclusion Criteria
Have any of the following:
- implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
- permanent pacemaker or ICD leads in the chamber being mapped
- hypercoagulopathy or an inability to tolerate anticoagulation during the procedure
- Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY)
- MI within the prior two (2) months
- Cardiac surgery within the prior three (3) months
- Intracardiac thrombus
- Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
- Cerebral ischemic event (including TIA) in the prior six (6) months
- Pregnant or nursing
- Currently enrolled in another clinical investigation
- Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
- Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
- Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
- Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY)
NOTE: The additional exclusion criteria for CL-SVT-004 were not expected to alter or bias the patient selection for study enrollment. While these criteria would have been assumed by other investigators as a standard of care for safe enrollment in a clinical study, the German EC approval required the additional statements.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Dipole Density Mapping
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Délai: 7 days
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Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure.
Each event was classified and adjudicated by the site-specific investigator.
The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.
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7 days
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The Number of Patients for Which Activation Maps Can be Created
Délai: 1 day
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The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
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1 day
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Petr Neuzil, MD, Nemocnice Na Homolce
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CL-SVT-005
- CL-SVT-002 (Autre subvention/numéro de financement: Acutus Medical)
- CL-SVT-001 (Autre identifiant: Acutus Medical)
- CL-SVT-004 (Autre identifiant: Acutus Medical)
- CL-SVT-006 (Autre identifiant: Acutus Medical)
- CL-SVT-008 (Autre identifiant: Acutus Medical)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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