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Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP) (Staged DEEP)

7 april 2017 uppdaterad av: AtriCure, Inc.

Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation

The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Belgien
      • Brussel, Belgien
        • Universitair Ziekenhuis Brussel
  • Förenta staterna
    • California
      • Stanford, California, Förenta staterna, 94305
        • Stanford University Medical Center
    • Colorado
      • Colorado Springs, Colorado, Förenta staterna, 80907
        • Colorado Springs Cardiology/Colorado Cardiac Alliance
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Vanderbilt Heart Institute
    • Virginia
      • Norfolk, Virginia, Förenta staterna, 23507
        • Sentara Norfolk Hospital
  • Nederländerna
      • Amsterdam, Nederländerna
        • Academic Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Age > 18 year
  • Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
  • Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)
  • Life expectancy of at least two years
  • Patient will and able to provide informed consent
  • Patient is willing and able to attend the scheduled follow-up visits

Exclusion Criteria:

  • Prior Cardiothoracic Surgery
  • Patient has NYHA (New York Heart Association) Class IV heart failure
  • Evidence of underlying structural heart disease requiring surgical treatment
  • Surgical procedure within the 30 days prior to the index procedure
  • Ejection fraction < 30%
  • Measured left atrial diameter > 6.0 cm
  • Renal Failure
  • Stroke within previous 6 months
  • Known carotid artery stenosis greater than 80%
  • Evidence of significant active infection or endocarditis
  • Pregnant woman or women desiring to become pregnant in the next 24 months
  • Presence of thrombus in the left atrium determined by echocardiography
  • History of blood dyscrasia
  • Contraindication to anticoagulation, based on Investigator's opinion
  • Mural thrombus or tumor
  • Moderate to Severe COPD

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: AtriCure Bipolar System combined with a catheter ablation
Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Enhet: Ablation procedure staged catheter ablation
AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Tidsram: 30 days post-index procedure or hospital discharge
Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
30 days post-index procedure or hospital discharge
Number of Subjects With Absence of Atrial Fibrillation
Tidsram: 12 month follow-up
Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.
12 month follow-up

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number Subjects With Serious Device or Procedure Related Adverse Event Rate
Tidsram: 12 month follow-up
12 month follow-up
Number of Subjects With Acute Procedure Success
Tidsram: Day 0

Defined as subject meeting all of the following criteria upon completion of the index-EP procedure

  1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);
  2. Bi-directional cavotricuspid isthmus block;
  3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);
  4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.
Day 0
Number of Subject Without Atrial Fibrillation
Tidsram: 6 and 12 month follow-up
AF free with or without the need of antiarrhythmic drugs
6 and 12 month follow-up
Number of Subjects With Reinterventions
Tidsram: 12 month follow-up
12 month follow-up
Number of Subjects With Direct Current (DC) Cardioversion
Tidsram: 12 month follow-up
12 month follow-up
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
Tidsram: 12 month follow-up

Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.

  1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.
  2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.
  3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .
12 month follow-up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AtriCure, Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2012

Primärt slutförande (Faktisk)

1 december 2015

Avslutad studie (Faktisk)

1 december 2015

Studieregistreringsdatum

Först inskickad

11 juli 2012

Först inskickad som uppfyllde QC-kriterierna

6 augusti 2012

Första postat (Uppskatta)

9 augusti 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 maj 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CP2012-1

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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