Atrial FibrillationAGILISNCT00469638
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
A study testing Left atrial catheter ablation guided by introducer using Agilis sheeth and Left atrial catheter ablation guided by introducer using Non-steerable sheeth in people with Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Left atrial catheter ablation guided by introducer using Agilis sheeth and Left atrial catheter ablation guided by introducer using Non-steerable sheeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- May 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.
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.
Read the 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
- Conditions
- Atrial Fibrillation
- Being tested
- Left atrial catheter ablation guided by introducer using Agilis sheeth, Left atrial catheter ablation guided by introducer using Non-steerable sheeth
- Keywords
- atrial fibrillation, paroxysmal, persistent, symptomatic, ablation, catheter, introducer, Agilis NxT, sinus rhythm, paroxysmal atrial fibrillation, persistent atrial fibrillation, symptomatic atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial catheter ablation guided by introducer using Agilis sheethProcedure or surgery
Left atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheethProcedure or surgery
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
| Study group | Role | What they receive |
|---|---|---|
| Agilis sheeth group | Experimental | Not described Receives: Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth |
| Non-steerable sheeth group | Active comparator | Not described Receives: Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
Measured: 6 months post ablation
Secondary outcomes (1)
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
Measured: 6 month post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerhard Hindricks, Prof. Dr., Principal investigator, Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469638
- Sponsor's protocol ID
- A07
- Acronym
- AGILIS
- Status last verified
- Feb 2019
- First submitted
- 3 May 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7062992Wolf 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.
PubMed 1866765Piorkowski 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
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.
PubMed 21248246
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.
- ClinicalTrials.gov ID
- NCT00469638
- Acronym / sponsor ID
- AGILIS / A07
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, paroxysmal, persistent, symptomatic, ablation, catheter, introducer, Agilis NxT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agilis sheeth group | Experimental | Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth |
| Non-steerable sheeth group | Active comparator | Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Permanent atrial fibrillation
- Pre existing left atrial fibrillation ablation
- Atrial fibrillation due to reversible cause
- Known intracardiac or other thrombi
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left atrial catheter ablation guided by introducer using Agilis sheethLeft atrial catheter ablation guided by introducer using Agilis sheeth | Procedure or surgery | Agilis sheeth group |
| Left atrial catheter ablation guided by introducer using Non-steerable sheethLeft atrial catheter ablation guided by introducer using Non-steerable sheeth | Procedure or surgery | Non-steerable sheeth group |
Primary outcome
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
Time frame: 6 months post ablation
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 7062992Kannel 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.
- Background: PubMed 1866765Wolf 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.
- BackgroundPiorkowski 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
- Derived from this study: PubMed 21248246Piorkowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Hindricks, Prof. Dr. principal investigator
Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left atrial catheter ablation guided by introducer using Agilis sheeth and Left atrial catheter ablation guided by introducer using Non-steerable sheeth in people with Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) (time frame: 6 months post ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469638, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.