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Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation: A Safety and Feasibility Study (LEIO-AF)

2. juni 2014 opdateret af: Royal Brompton & Harefield NHS Foundation Trust

The Safety and Feasibility of Concomitant Left Atrial Appendage Electrical Isolation and Occlusion in the Treatment of Persistent Atrial Fibrillation

Atrial fibrillation (AF) affects as many as 1 in 16 people over the age of 65 and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. Recent studies have identified that a particular area of the heart, namely the left atrial appendage (LAA), which is a pouch in the left atrium (small collecting chamber of the heart), may be the main source of AF in many cases. There is a clear lack of knowledge about the structure, anatomy, function and electrical properties of the LAA, which is fundamental to furthering our understanding and management of AF.

In addition, it is well known that AF significantly increases the risk of stroke. The majority of strokes occur due to blood clots forming in the LAA. Traditionally, the most effective treatment to minimise the risk of stroke has been to thin the blood with agents such as warfarin. This therapy requires regular blood tests at much inconvenience to patients and increases the risk of bleeding complications. Recently, a large study demonstrated that use of an implanted device (Watchman®) to occlude the LAA is as effective as warfarin in preventing stroke and confers a lower mortality rate.

We aim to investigate whether it is safe and feasible to ablate the LAA and to implant a Watchman® device during the same procedure in patients who are in atrial fibrillation all of the time.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

While catheter ablation has revolutionized the treatment of atrial fibrillation (AF), the long-term outcomes in treating persistent AF are variable, often requiring more than one procedure to maintain long-term freedom from AF. Electrical isolation of the pulmonary veins (PVs) is central to catheter ablation strategies, with the majority of paroxysmal AF recurrences being associated with reconnection of previously isolated PVs. Persistent AF is different, with recurrences being attributable to foci and or substrate outside the PVs, including the left atrial appendage (LAA). Recently, a non-randomised, consecutive study of 987 patients undergoing repeat catheter ablation for persistent (82%) and paroxysmal (18%) AF has demonstrated that almost 30% of recurrences were due to an LAA focus and that the addition of LAA electrical isolation to a standard persistent AF ablation strategy improves freedom from AF.

Percutaneous LAA occlusion has been demonstrated to be as effective as warfarin in reducing the risk of thromboembolic stroke in patients with AF. The combination of a standard AF ablation lesion set with LAA electrical isolation and LAA occlusion may be an elegant method of improving success rates of ablation for persistent AF whilst also mitigating stroke risk and reducing the bleeding risks from long-term anticoagulation. However, the feasibility and safety of concomitant endocardial electrical isolation and mechanical occlusion of the LAA is not known.

In this study we test the hypothesis that concomitant electrical isolation of the LAA and its occlusion with a Watchman device, following a standard persistent AF lesion set is feasible and safe.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Det Forenede Kongerige
    • Greater London
      • London, Greater London, Det Forenede Kongerige, SW3 6NP
        • Royal Brompton & Harefield NHS Foundation Trust

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 - 80 years
  • Symptomatic, documented AF lasting for at least 7 days (persistent or permanent AF) refractory to at least 1 AAD and/or DCCV
  • Long-term indication to continue warfarin

Exclusion Criteria:

  • Previous ablation procedure
  • Pregnancy
  • Prior AV nodal ablation or complete heart block (CHB) with a permanent pacemaker (PPM)
  • Contraindication to anticoagulation
  • Persistent thrombus in the left atrium despite anticoagulation
  • Active malignancy
  • Expected life expectancy < 6 months
  • Cerebrovascular accident within the previous 6 months
  • Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
  • Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months
  • Prior left atrial catheter ablation with the intention to treat AF
  • Prior surgical interventions for AF such as the MAZE procedure
  • Previous heart transplant
  • Severe neuro-muscular disease
  • Creatinine clearance <30 ml/min (estimated GFR)
  • Current participation in another research study
  • Unable to understand and comply with protocol or to give written informed consent
  • Contraindication to general anaesthesia

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
Eksperimentel: LAA electrical isolation + occlusion
Standard persistent AF ablation protocol + LAA electrical isolation + Watchman device implantation to occlude LAA
Procedure: LAA electrical isolation + occlusion
LAA electrical isolation + Watchman device implantation to occlude LAA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of concomitant LAA electrical isolation and percutaneous left atrial appendage occlusion using Watchman® device in patients with persistent atrial fibrillation
Tidsramme: At time of procedure
Success rates of LAA electrical isolation and Watchman® device implantation post-LAA isolation will be determined during index procedures
At time of procedure
Freedom from serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up
Tidsramme: Immediately after the procedure and at 6 months
Serious adverse event rate will be determined immediately after the procedure and during the 6 month follow-up period
Immediately after the procedure and at 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Efterforskere

  • Ledende efterforsker: Tom Wong, MD, Royal Brompton & Harefield NHS Foundation Trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. juli 2013

Primær færdiggørelse (Forventet)

1. oktober 2014

Studieafslutning (Forventet)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

3. januar 2014

Først indsendt, der opfyldte QC-kriterier

3. januar 2014

Først opslået (Skøn)

6. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012CI004B, 12/LO/0809
  • 94318 (Anden identifikator: NIHR CSP)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Vedvarende atrieflimren

Kliniske forsøg med LAA electrical isolation + occlusion

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Betingelser

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