Atrial Fibrillation Ablation Pilot Study
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ablation procedure and/or cardioversion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.)
Sites / Locations
- St. Antonius Ziekenhuis
- Klinic im Park
- Papworth Hospital
- St. George's University of London
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Ablation Management
Outcomes
Primary Outcome Measures
The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.
Secondary Outcome Measures
Effectiveness
Full Information
NCT ID
NCT00744835
First Posted
August 28, 2008
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT00744835
Brief Title
Atrial Fibrillation Ablation Pilot Study
Official Title
Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ablation Management
Intervention Type
Procedure
Intervention Name(s)
Ablation procedure and/or cardioversion
Intervention Description
Ablation Frontiers Cardiac Ablation System
Primary Outcome Measure Information:
Title
The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effectiveness
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.)
Facility Information:
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Klinic im Park
City
Zürich
Country
Switzerland
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
St. George's University of London
City
London
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.ablationfrontiers.com
Description
Company website
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Atrial Fibrillation Ablation Pilot Study
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