- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01695551
Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia
Assessment of Intracardiac and Surgace Electrogram Characteristics Correlated to Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia
Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal electrical pathways located in the heart tissue. A standard procedure called a catheter ablation has been used for several years to help correct these abnormal pathways and, in some cases, improve or even eliminate the ventricular tachycardia.
During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate, and oxygen saturation in your blood). If you choose to participate in this study we will also monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your brain during the ablation.
By doing this study, we hope to have a better understanding of patients' blood and oxygen flow to their brain during an episode of Ventricular Tachycardia (VT).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Able to give informed consent
- Have implantable defibrillator in-situ and are undergoing ablation procedure for ventricular tachycardia
Exclusion Criteria:
- Patients who have been hypotensive with systolic blood pressure of < 80mm Hg prior to procedure
- Cerebral event as defined by Cerebrovascular Accident or Transient Ischemia Attack within six months prior to procedure
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Ventricular Tachycardia
Participants in cohort will have implantable defibrillators in-situ and are undergoing ablation procedure for ventricular tachycardia.
|
Participants will be asked questions relating to pre-procedure items and be asked to complete an MMSE.
Subjects receive standard of care surgery.
Data collected from procedures before, during and after surgery.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Identify clinical, EKG and EGM characteristics of hemodynamically unstable VT
Tidsramme: Change from Baseline to 24-48 hours after surgery
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The investigator will be evaluating the relationship of the oxygenation level of the brain during a Ventricular Tachycardia ablation.
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Change from Baseline to 24-48 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MMSE to determine cerebral function before and after VT ablation
Tidsramme: 24 hours after surgery
|
The use of the Mini-Mental Status Exam prior to the ablation will serve as a reference point and will be repeated 24 hours post exam.
|
24 hours after surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13054
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