Efficacy and Safety Study on Agilis NxT Introducer in AF Patients (AGILIS)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Left atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, paroxysmal, persistent, symptomatic, ablation, catheter, introducer, Agilis NxT, sinus rhythm, paroxysmal atrial fibrillation, persistent atrial fibrillation, symptomatic atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- Paroxysmal or persistent symptomatic atrial fibrillation
- Resistant to at least 1 anti arrhythmic drug
- Left atrial diameter less then 60 mm (TTE, parasternal)
- Atrial fibrillation documented by ECG
- Patient is willing and available to perform all Follow Ups
Exclusion Criteria:
- Permanent atrial fibrillation
- Pre existing left atrial fibrillation ablation
- Atrial fibrillation due to reversible cause
- Known intracardiac or other thrombi
- Pregnancy
- Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
- Contraindication for anticoagulation
Sites / Locations
- Herzzenturm Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Agilis sheeth group
Non-steerable sheeth group
Arm Description
Outcomes
Primary Outcome Measures
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
Secondary Outcome Measures
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) at 3 months post ablation rate of pulmonary vein isolation completely isolated rate of complications procedure duration X-ray duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00469638
Brief Title
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
Acronym
AGILIS
Official Title
Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.
Detailed Description
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.
Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, paroxysmal, persistent, symptomatic, ablation, catheter, introducer, Agilis NxT, sinus rhythm, paroxysmal atrial fibrillation, persistent atrial fibrillation, symptomatic atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Agilis sheeth group
Arm Type
Experimental
Arm Title
Non-steerable sheeth group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Left atrial catheter ablation guided by introducer using Agilis sheeth
Intervention Description
Left atrial catheter ablation guided by introducer using Agilis sheeth
Intervention Type
Procedure
Intervention Name(s)
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Intervention Description
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Primary Outcome Measure Information:
Title
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
Time Frame
6 months post ablation
Secondary Outcome Measure Information:
Title
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) at 3 months post ablation rate of pulmonary vein isolation completely isolated rate of complications procedure duration X-ray duration
Time Frame
6 month post ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Paroxysmal or persistent symptomatic atrial fibrillation
Resistant to at least 1 anti arrhythmic drug
Left atrial diameter less then 60 mm (TTE, parasternal)
Atrial fibrillation documented by ECG
Patient is willing and available to perform all Follow Ups
Exclusion Criteria:
Permanent atrial fibrillation
Pre existing left atrial fibrillation ablation
Atrial fibrillation due to reversible cause
Known intracardiac or other thrombi
Pregnancy
Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
Contraindication for anticoagulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Hindricks, Prof. Dr.
Organizational Affiliation
Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzenturm Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
7062992
Citation
Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22. doi: 10.1056/NEJM198204293061703.
Results Reference
background
PubMed Identifier
1866765
Citation
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.
Results Reference
background
Citation
Piorkowski C, Hindricks G, Weiss S et al: Long term outcome of circumferential left atrial PV ablation using a steerable transseptal sheath. Poster European Society of Cardiology 2006, Barcelona
Results Reference
background
PubMed Identifier
21248246
Citation
Piorkowski C, Eitel C, Rolf S, Bode K, Sommer P, Gaspar T, Kircher S, Wetzel U, Parwani AS, Boldt LH, Mende M, Bollmann A, Husser D, Dagres N, Esato M, Arya A, Haverkamp W, Hindricks G. Steerable versus nonsteerable sheath technology in atrial fibrillation ablation: a prospective, randomized study. Circ Arrhythm Electrophysiol. 2011 Apr;4(2):157-65. doi: 10.1161/CIRCEP.110.957761. Epub 2011 Jan 19.
Results Reference
derived
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Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
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