Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment (ULTRA-FAST)
Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication.
Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied.
The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated.
The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Tokyo, Japan, 166-8588
- Kawakita General Hospital
-
-
-
-
-
Liberec, Tschechien, 46001
- Regional Hospital Liberec
-
Prague, Tschechien, 16902
- Ustredni vojenska nemocnice
-
Prague 4, Tschechien, 14021
- Institute for Clinical and Experimental Medicine
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.
Exclusion Criteria:
- Patients with prior known vascular access problems or priory included to the current study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Real-time ultrasound-guided puncture
Cannulate each femoral veins with two wires with real-time ultrasound-guided method.
|
A 7 megahertz ultrasound linear probe will be used.
|
|
Sonstiges: Anatomical landmark guided puncture
Cannulate each femoral veins with two wires with the anatomical landmark guided method.
|
Anatomical landmark puncture
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Major complications
Zeitfenster: After the puncture up to 12 weeks
|
Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 >g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge.
|
After the puncture up to 12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Unsuccessful femoral vein cannulation
Zeitfenster: Immediately after the puncture
|
Number of patients with unsuccessful femoral vein cannulation defined as crossing over to the other randomized method or change of operator to cannulate all wires.
|
Immediately after the puncture
|
|
Number of puncture attempts
Zeitfenster: Immediately after the puncture
|
Number of puncture attempts to cannulate all wires.
|
Immediately after the puncture
|
|
Total puncture time
Zeitfenster: Immediately after the puncture
|
Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray.
|
Immediately after the puncture
|
|
Number of artery mis-punctures
Zeitfenster: Immediately after the puncture
|
Number of artery mis-punctures attempts to cannulate all wires.
|
Immediately after the puncture
|
|
Use of X-ray for successful wire cannulation
Zeitfenster: Immediately after the puncture
|
If there is a need of X-ray to cannulate the wire into the infra vena cava.
|
Immediately after the puncture
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Joseph Kautzner, MD, PhD, Institute for Clinical and Experimental Medicine
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ULTRA-FAST
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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 .