- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01721642
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device During and After Transcatheter Aortic Valve Implantation (TAVI) Procedures
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subject age ≥ 18 years of age.
Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. Subjects selected will meet all of the TAVI inclusion criteria as follows:
- Subject has Senile degenerative aortic stenosis with echocardiography derived criteria: mean gradient > 40 mm Hg or jet velocity > 4.0 m/s or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2.
- Subject is symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class > II.
- Additive EuroScore > 9
- Aortic annulus diameter > 21mm to < 27mm by TEE
- The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- The subject, after formal consults by a cardiologist and two cardiovascular surgeons agreed that medical factors precluding operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeded the probability of meaningful improvement. Specifically the probability of death or serious, irreversible morbidity exceeded 50%.
Exclusion Criteria:
Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. The following TAVI exclusion criteria shall apply:
- Evidence of an acute myocardial infarction < 1 month before the intended treatment
- Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
- Pre-existing prosthetic heart valve in an position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
- Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
- Need for emergency surgery for any reason
- Hypertrophic cardiomyopathy with or without obstruction
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
- A known hypersensitivity of contraindication to asprin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated
- Recent (within 6 months) cerebrovascular accident or transient ischemic attack
- Renal insufficiency and/or end stage renal disease requiring chronic dialysis.
- Life expectancy < 12 months due to non-cardiac co-morbid conditions.
The following ASC device exclusion criteria shall apply:
- Subjects with <10mm Left ventricular wall thickness at apical access site
- LVEF < 30%
- Subject with previous DOR procedure
- Subject access site has less than 2 cm squared "fat" free area under visual observation
- Subject has known Allergy or hypersensitivity to Titanium
- Subject requires MR Imaging post procedure
- Subject is Pregnant
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Apica Cardiovascular ASC Device
Access, stabilisation and closure with the Apica Cardiovascular ASC Device
|
Access, stabilisation and closure of trans-apical approach for TAVI
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Access safety
Lasso di tempo: Within 2 hours from initial skin incision
|
Observation of no myocardial tearing on entry of the device
|
Within 2 hours from initial skin incision
|
Closure safety
Lasso di tempo: Within 2 hours from initial skin incision
|
Observation of no acute post-procedural bleeding or pericardial effusion.
|
Within 2 hours from initial skin incision
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Investigational device performance: LV function
Lasso di tempo: 24 hours, 30 days and 90 days post-procedure
|
% LVEF no worse than baseline as assessed by echocardiography
|
24 hours, 30 days and 90 days post-procedure
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Thomas Walther, Prof, Kerckhoff Klinik
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CIP-DP1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Stenosi della valvola aortica
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National Heart, Lung, and Blood Institute (NHLBI)CompletatoNative e Valve in Valve Guasto della valvola aorticaStati Uniti