- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02089672
RF Lesion Monitoring With 8mm IntellaTip MiFi XP
Radiofrequency Ablation Lesion Monitoring Using Imbedded Micro-Electrodes Versus Standard Bipolar Electrograms
Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. These catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. In the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized.
When sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (EGM). To produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the EGM. The distance between the two electrodes varies from device to device. The greater the distance between them, the less accurate the measurement of local electrical activity becomes. This may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (<1 mm apart) with the hope of improving the sensing capability of the device.
This study will analyze the signals obtained from this FDA-approved catheter in people undergoing a catheter ablation procedure. The study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. The goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Any adult undergoing an atrial flutter ablation
Exclusion Criteria:
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Atrial flutter patients
Atrial flutter patients undergoing catheter ablation
|
This is observational trial studying the effects of a standard intervention of a catheter ablation procedure.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total bipolar electrogram amplitude using tip to ring and pin to pin configurations
Tidsramme: Acute, averaged one hour during ablation. Measured postoperatively.
|
Acute, averaged one hour during ablation. Measured postoperatively.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total number of seconds per isthmus ablation spent in excess of the post-hoc identified complete lesion time.
Tidsramme: Acute, averaged one hour during ablation. Measured postoperatively
|
Acute, averaged one hour during ablation. Measured postoperatively
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael Lloyd, MD FHRS FACC, Emory University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Hogh Petersen H, Chen X, Pietersen A, Svendsen JH, Haunso S. Lesion dimensions during temperature-controlled radiofrequency catheter ablation of left ventricular porcine myocardium: impact of ablation site, electrode size, and convective cooling. Circulation. 1999 Jan 19;99(2):319-25. doi: 10.1161/01.cir.99.2.319.
- Sanchez JE, Kay GN, Benser ME, Hall JA, Walcott GP, Smith WM, Ideker RE. Identification of transmural necrosis along a linear catheter ablation lesion during atrial fibrillation and sinus rhythm. J Interv Card Electrophysiol. 2003 Feb;8(1):9-17. doi: 10.1023/a:1022315308803.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00069674
- ISRCRM90003 (Annen identifikator: Other)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Catheter ablation
-
Pentax MedicalFullførtColdplay kryoablasjon av dysplastisk plateepitelvev hos pasienter med esophageal plateepiteldysplasiEsophageal plateepiteldysplasiKina
-
Pentax MedicalFullførtEvaluering av effekten av CryoBalloon Focal Ablation System på Human Esophageal Barrett's EpitheliumBarretts spiserørForente stater, Nederland
-
University of AdelaideBoston Scientific Corporation; Medtronic; Abbott Medical DevicesFullførtHjertefeil | AtrieflimmerAustralia, Storbritannia, New Zealand, Malaysia, Tyskland
-
Johns Hopkins UniversityRekrutteringKronisk smerte | Nakkesmerter | Cervical fasett leddsmerterForente stater
-
Mayo ClinicPentax MedicalFullført
-
University Hospital, ToulouseFullført
-
Acutus MedicalTilbaketrukket
-
Farapulse, Inc.FullførtParoksysmal atrieflimmerTsjekkia, Frankrike
-
University of CalgaryRekruttering
-
Hangzhou Valgen Medtech Co., LtdAktiv, ikke rekrutterendeObstruktiv hypertrofisk kardiomyopatiKina