Atrial FibrillationPhase 1NCT00744835
Atrial Fibrillation Ablation Pilot Study
A Phase 1 study testing Ablation procedure and/or cardioversion in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in 3 countries.
Trial summary
This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation procedure and/or cardioversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2006to Jul 2008
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of symptomatic permanent atrial fibrillation
- Age between 18 and 70
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Who cannot join
- Structural heart disease of clinical significance
- Any prior ablation for atrial fibrillation
- Prior ablation for arrhythmias other than AF within the past three months
- Enrollment in any other ongoing arrhythmia study protocol
- Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
- Active infection or sepsis
Show all 15Show fewer
- Any history of cerebral vascular disease including stroke or TIAs
- Pregnancy or lactation
- Left atrial thrombus at the time of ablation
- Untreatable allergy to contrast media
- Any diagnosis of AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
- History of blood clotting (bleeding or thrombotic) abnormalities
- Known sensitivities to heparin or warfarin
- Severe COPD (identified by an FEV1 < 1)
- Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
Papworth Hospital
Cambridge
St. George's University of London
London
St. Mary's Hospital
London
About this study
Official title: Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20
This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.
Read the detailed description
The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including "roll-in" or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system.
Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation procedure and/or cardioversion
- Keywords
- 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.
Ablation procedure and/or cardioversionProcedure or surgery
Ablation Frontiers Cardiac Ablation System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ablation Management Receives: Procedure: Ablation procedure and/or cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.
Measured: 6 months
Secondary outcomes (1)
Effectiveness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744835
- Sponsor's protocol ID
- AFI-20
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2008
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20
- ClinicalTrials.gov ID
- NCT00744835
- Acronym / sponsor ID
- AFI-20
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 1 Sep 2008 (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.
This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.
Detailed description
The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including "roll-in" or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system.
Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Ablation procedure and/or cardioversionAblation Management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of symptomatic permanent atrial fibrillation
- Age between 18 and 70
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Key exclusion criteria (15 listed)
- Structural heart disease of clinical significance
- Any prior ablation for atrial fibrillation
- Prior ablation for arrhythmias other than AF within the past three months
- Enrollment in any other ongoing arrhythmia study protocol
- Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
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 |
|---|---|---|
| Ablation procedure and/or cardioversionAblation Frontiers Cardiac Ablation System | Procedure or surgery | 1 |
Primary outcome
The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.
Time frame: 6 months
1 secondary outcome
Effectiveness
Time frame: 6 months
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 19 Sep 2018.
- Company websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ablation procedure and/or cardioversion in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in 3 countries.
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 3 inclusion and 15 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Netherlands, Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2018.