- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01095952
AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF (AVNS)
14. februar 2014 opdateret af: Medtronic BRC
Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study
The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling ventricular rate (VR) during rapidly conducted atrial fibrillation (AF) by delivering AV node stimulation (AVNS) from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks.
Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium.
About 37 patients will be followed for half a year.
Studieoversigt
Detaljeret beskrivelse
The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling VR during rapidly conducted AF by delivering AVNS from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks.
Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium.
About 37 patients will be followed for half a year.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Firenze, Italien, 50134
- Institute of Internal Medicine and Cardiology, Firenze
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Rome, Italien, I- 00186
- Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome
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Uppsala, Sverige, SE-751 85
- Department of Cardiology, university hospital
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Aachen, Tyskland, 52074
- Klinikum Aachen
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with a documented history of paroxysmal or persistent AF are eligible to be enrolled in the study if one of the following criteria is met:
- Indication for CRT implant according to current Guidelines (Heart Failure, NYHA III-IV class, symptomatic despite optimal stable medical therapy, left ventricular (LV) ejection fraction ≤35% and QRS≥120ms); OR
- Indication for upgrading to CRT-D from a single chamber device; OR
- Indication for upgrading to CRT-D from a dual chamber device with septal atrial lead or a dislodged atrial lead; OR
- Indication for device replacement or surgical revision in patients already implanted with a CRT-D device and an atrial lead in the septal position or a dislodged atrial lead; OR
- Patients already implanted with a ConsultaTM device and an atrial lead in the septal position, requiring electrical cardioversion.
Exclusion Criteria:
- If any of the following criteria are met, patient cannot be enrolled in the study:
- Permanent atrial fibrillation;
- Patients who are not on anti-coagulant therapy;
- Advanced AV block (II-III degree AV block);
- Patients previously submitted to valvular surgery;
- Patients previously submitted to AV or AF ablative procedures;
- Age < 18 years;
- Patient not disposed to sign the Informed Consent;
- Participation in other studies which could potentially conflict with this study;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: AVNS ON
Consulta downloaded with AVNS to provide high frequency bursting during fastly conducted AF.
AVNS will be programmed on for five months.
The feasibility and safety of the AVNS algorithm to reduce inappropriate shocks will be monitored.
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Delaying the AV-node by stimulating the parasympathetic nerves innervating the AV-node with high frequency burst pacing during the refractory period of the ventricle using a standard atrial lead at a septal position.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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To evaluate the performance of the investigational algorithm in reducing mean VR during AF, the relative reduction of VR during AVNS will be assessed in acute in-hospital tests, conducted preferably during either spontaneous or induced episodes of AF.
Tidsramme: baseline and 1 month
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baseline and 1 month
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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To evaluate the performance of the investigational algorithm in shock reduction.
Tidsramme: baseline, 1 month, 3 months, 6 months
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assessing the number of successful rate reduction interventions by AVNS during spontaneous episodes of AF occurring during follow-up, with rapid VR due to AF conducted in the VT/FVT/VF zone;
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baseline, 1 month, 3 months, 6 months
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To evaluate the safety of the investigational algorithm.
Tidsramme: baseline, 1 month, 3 months, 6 months
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To evaluate the safety of the investigational algorithm, assessing:
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baseline, 1 month, 3 months, 6 months
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To gather data for further possible applications.
Tidsramme: baseline, 1 month, 3 months, 6 months
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To gather data for further possible applications of AVNS, assessing:
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baseline, 1 month, 3 months, 6 months
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To collect data on selective placement of the atrial lead.
Tidsramme: baseline, 1 month, 3 months, 6 months
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evaluating:
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baseline, 1 month, 3 months, 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Stephano Bianchi, MD, Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bianchi S, Rossi P, Della Scala A, Kornet L, Pulvirenti R, Monari G, Di Renzi P, Schauerte P, Azzolini P. Atrioventricular (AV) node vagal stimulation by transvenous permanent lead implantation to modulate AV node function: safety and feasibility in humans. Heart Rhythm. 2009 Sep;6(9):1282-6. doi: 10.1016/j.hrthm.2009.05.011. Epub 2009 May 9.
- Rossi P, Bianchi S, Barretta A, Della Scala A, Kornet L, De Paulis R, Bellisario A, D'Addio V, Pavaci H, Miraldi F. Post-operative atrial fibrillation management by selective epicardial vagal fat pad stimulation. J Interv Card Electrophysiol. 2009 Jan;24(1):37-45. doi: 10.1007/s10840-008-9286-2. Epub 2008 Aug 30.
- Bianchi S, Rossi P, Della Scala A, Kornet L. Endocardial transcatheter stimulation of the AV nodal fat pad: stabilization of rapid ventricular rate response during atrial fibrillation in left ventricular failure. J Cardiovasc Electrophysiol. 2009 Jan;20(1):103-5. doi: 10.1111/j.1540-8167.2008.01243.x. Epub 2008 Jul 3.
- Bianchi S, Rossi P, Schauerte P, Elvan A, Blomstrom-Lundqvist C, Kornet L, Gal P, Mortsell D, Wouters G, Gemein C. Increase of ventricular interval during atrial fibrillation by atrioventricular node vagal stimulation: chronic clinical atrioventricular-nodal stimulation download study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):562-8. doi: 10.1161/CIRCEP.114.002588. Epub 2015 Apr 15.
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
1. november 2011
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
11. marts 2010
Først indsendt, der opfyldte QC-kriterier
26. marts 2010
Først opslået (Skøn)
30. marts 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. februar 2014
Sidst verificeret
1. februar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AVNS
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Henry Ford Health SystemTrukket tilbage
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz
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Occlutech International ABAfsluttetSecundum atrial septal defekter
Kliniske forsøg med AVNS ON
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Vertex Pharmaceuticals IncorporatedAfsluttetMyelomatose | Hodgkins lymfom | Non-Hodgkins lymfom | Waldenstroms makroglobulinæmi | Akut leukæmi | Kronisk leukæmiForenede Stater
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First Affiliated Hospital of Zhejiang UniversityRekruttering
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On-X Life Technologies, Inc.AfsluttetHjerteklapsygdomForenede Stater, Puerto Rico, Spanien
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University of PittsburghAfsluttet
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M.D. Anderson Cancer CenterIkke rekrutterer endnu
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University of UtahAktiv, ikke rekrutterende
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Andrew KrystalRekrutteringStørre depressiv lidelseForenede Stater
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Hacettepe UniversityInteract Medical Technologies Inc.Ikke rekrutterer endnuSlag | Øvre ekstremitetKalkun
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University of UtahNational Institute of Nursing Research (NINR)Rekruttering
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University of the Basque Country (UPV/EHU)University of the Balearic Islands; University of Extremadura; Universitat... og andre samarbejdspartnereAfsluttet