- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03247465
Image Fusion and Calcification Raising in Trans Aortic Valve Implantation (TAVI)
Value of Fusion of 3D Images With 2D Images, Associated With Calcification Raising During Trans Aortic Valve Implantation Procedures
Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve implantation (TAVI) has been developed since 2002, first to treat rejected patients from conventional surgery, then to treat high surgical risk patients and nowadays probably intermediate surgical risk patient. TAVI related complications are still recurrent and the investigators are searching a way to decrease them.
One of them could be image fusion, since it may decrease radiation exposure and contrast agent use. It may also improve valve placement position leading to decreased complications.
40 prospective and consecutive patients will be included. Participants will be divided into two groups: the 20 first included will be control group, the 20 following patients will be the fusion group. For control group TAVI procedure will be the usual one, for fusion group the procedure will be the usual one with addition of computed tomography 3D images fusion with fluoroscopy 2D images.
Main evaluation criteria will be radiation exposure, measured by dose area product (DAP). Secondary evaluation criterion will be procedural as contrast agent volume used, procedure duration, subjective usefulness of image fusion or procedure failure evaluated immediately after procedure. The investigators will also evaluated procedure induced complications as de novo pacemaker implantation, de novo left bundle branch, vascular complication, major bleeding, acute kidney failure, significant aortic regurgitation. These complications occurrence will be evaluated after 1 month follow up, during the usual following consultation.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Aortic stenosis is one of the most common cardiology diseases. If untreated, symptomatic aortic stenosis rapidly leads to death. Most of the time, this disease affects old fragile people for whom conventional surgery is countered or very risky. That is why Trans aortic valve implantation has been developed since 2002, first to treat rejected patients from conventional surgery, then to treat high surgical risk patients and nowadays probably intermediate surgical risk patient. Indeed, thanks to prodigious technical and human progress, procedure induced complication have clearly decreased. But TAVI related complications are still recurrent and the investigators are searching a way to decrease them.
One of them could be image fusion, since it may decrease radiation exposure and contrast agent use correlated to acute kidney failure. It may also improve valve placement position, and the investigators know that many rhythmic (atrio-ventricular block) and valvular (significant aortic regurgitation) complications are partially due to placement mistakes. So the investigators hope that image fusion will decrease these complications.
The investigators will include 40 prospective and consecutive patients. Inclusion criterion will be all major patients admitted in Nantes CHU for transfemoral aortic valve replacement with SAPIEN® 3 valve. Exclusion criterion will be women of childbearing age without contraception, impossible written consent, judiciary protected people. After inclusion, patients will be divided into two groups: the 20 first included will be control group, the 20 following patients will be the fusion group. For control group TAVI procedure will be the usual one, for fusion group the procedure will be the usual one with addition of computed tomography 3D images fusion with fluoroscopy 2D images. The only difference during all patient medical care will be the addition of image fusion in fusion group. Before and after procedure, both groups will have the usual medical monitoring and the appropriated medical interventions to participants case.
Main evaluation criterion will be radiation exposure, measured by dose area product (DAP).
Secondary evaluation criterion will be procedural as:
- contrast agent volume used (mL),
- procedure duration (min),
- subjective usefulness of image fusion evaluated on a 0 to 3 scale
- procedure failure : death, more than one valve implantation, valve dysfunction (mean trans-valvular gradient > 20 mmHg or moderate to severe aortic regurgitation) These criterions will be evaluated immediately after procedure.
The investigators will also evaluated procedure induced complications as:
- de novo pacemaker implantation
- de novo left bundle branch
- non minor vascular complication on VARC-2 definition
- major bleeding (BARC 3 or 5)
- acute kidney failure (AKIN 2 or 3)
- significant aortic regurgitation ≥ 2/4 These complications occurrence will be evaluated after 1 month follow up, during the usual following consultation with echocardiography.
Then differences between will be tested with appropriated statistical methods.
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Nantes, Frankreich, 44093
- Nantes University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- All patients admitted in Nantes CHU for trans fermoral aortic valve replacement with SAPIEN 3® device
- Patient who accepted to participate to the study
Exclusion Criteria:
- Impossible written consent
- Judiciary protected people
- Minor
- Women of childbearing age without contraception
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Group "Fusion"
Trans aortic valve replacement with usual procedure with the addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.
|
Addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.
|
Kein Eingriff: Group "Control"
Trans aortic valve replacement with usual procedure
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Radiation exposure
Zeitfenster: Immediately post procedure
|
Dose area product (cGy/cm2)
|
Immediately post procedure
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Contrast product
Zeitfenster: Immediately post procedure
|
Contrast volume (mL) used during procedure
|
Immediately post procedure
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RC17_0114
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Image Fusion
-
Uppsala UniversityAbgeschlossenLumbale Spinalkanalstenose
-
AOSpine North America Research NetworkAbgeschlossenIsthmische SpondylolistheseVereinigte Staaten, Kanada
-
Andrews Research & Education FoundationBREG, IncAbgeschlossen
-
Kyungpook National University HospitalUnbekanntDegenerative Spondylolisthese | Transforaminale lumbale interkorporelle FusionKorea, Republik von
-
ExactechBeendetDegenerative Bandscheibenerkrankungen | Spondylolisthese | StenoseVereinigte Staaten
-
Karolinska InstitutetSkane University HospitalAktiv, nicht rekrutierendArthrose am HandgelenkSchweden
-
Lahey ClinicPatient-Centered Outcomes Research InstituteAktiv, nicht rekrutierendZervikale Spondylose mit MyelopathieVereinigte Staaten, Kanada
-
Duke UniversityZurückgezogenChirurgie | Degenerative Bandscheibenerkrankungen | Bandscheibenerkrankung der Halswirbelsäule | Fusion der Wirbelsäule
-
SeaSpine, Inc.AbgeschlossenSpondylose | Stenose | Degenerative VeränderungenVereinigte Staaten
-
SeaSpine, Inc.AbgeschlossenSpondylose | Stenose | Degenerative VeränderungenVereinigte Staaten