Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
1. juli 2014 opdateret af: University of Oklahoma
The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:
- Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis;
- Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism;
- These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);
- Patients with interruption of the vagal response (sinus bradycardia or AV block) during stimulation at the sites of left atrial autonomic ganglionated plexi (GP) will have lower recurrence of atrial fibrillation.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
119
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age greater or equal to 18 years
- At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
- Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
- Informed consent obtained.
Exclusion Criteria:
- Left atrial thrombus
- Acute myocardial infarction within eight (8) weeks
- Atriotomy within eight (8) weeks
- Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
- Pregnancy
- Ablation in a pulmonary vein within 4 months.
- Occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
- Enrolled in an investigational study evaluating another device or drug
- Unwilling to participate in the study or unavailable for follow-up visits.
- Incarcerated
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: GP + PVI ablation
This study contains only one arm, which is GP ablation + PV antrum isolation.
The intervention (GP ablation + PV isolation) was performed using ThermoCool Navistar catheters in all patients
|
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Atrial Tachyarrhythmia Recurrence in Participants
Tidsramme: 0-5 years
|
Outcome is determined by recurrence of atrial tachyarrhythmia in participants.
Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring.
Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients.
Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.
|
0-5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Number of Significant Ablation Procedure Related Complications
Tidsramme: 0-1 year
|
Any complication directly related to the ablation procedure was included.
These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.
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0-1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Sunny Po, MD, University of Oklahoma
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2004
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først indsendt
20. december 2007
Først indsendt, der opfyldte QC-kriterier
31. december 2007
Først opslået (Skøn)
2. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 010971
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