Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Steerable Sheath System
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS Criteria.
- Eighteen to Eighty years of age
- Signed informed consent
Exclusion Criteria:
- Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
- Severe cerebrovascular disease or history of cerebrovascular event within one (1) month
- Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29.
- Active gastrointestinal bleeding, infection or fever (> 100.5/38C)
- Severe co morbidity or Short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease
Structural heart disease of clinical significance including
- Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing
- Stable/unstable angina or ongoing myocardial ischemia
- Myocardial infarction (MI) within three months of enrollment
- Aortic or mitral valve disease > Grade II
- Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
- Enrollment in any other ongoing arrhythmia study protocol
- Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
- Active infection or sepsis
- Female patient is pregnant or lactating
- Untreatable allergy to contrast media
- Any diagnosis of atrial fibrillation 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Steerable sheath for intracardiac access
Arm Description
Vado Steerable sheath system consisting of a dilator and steerable sheath for left atrial access, positioning of ablation catheters and placement of mapping and ablation catheters for circumferential ablation
Outcomes
Primary Outcome Measures
Absence of adverse device related events at release from hospital post procedure per institutional standard of care
Steerability and positioning to facilitate catheter placement
Secondary Outcome Measures
Hemostasis and Visibility of the steerable sheath
Safe event free insertion of the steerable sheath system in the femoral vein
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02521896
Brief Title
Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
Official Title
Vado™ Steerable Sheath System; A Safety and Performance Study to Evaluate Access to the Pulmonary Veins in the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kalila Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation and persistent atrial fibrillation (AF). The study will be a prospective, single-center, non-randomized investigation.
Detailed Description
The design for this study involves the sequential enrollment of patients with documented paroxysmal atrial fibrillation who have had two (2) or more AF episodes for at least 30 seconds in length within six (6) months prior to enrollment. Target population shall be selected from the treatable AF population that meets both inclusion/exclusion criteria.It is intended that the Vado Steerable Sheath will be used as part of standard clinical workflow procedures, with no procedural deviations relative to other procedures requiring steerable sheaths. Individual subjects will be studied during mapping and ablation procedures and followed until release from hospital post procedure per institutional standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Steerable sheath for intracardiac access
Arm Type
Experimental
Arm Description
Vado Steerable sheath system consisting of a dilator and steerable sheath for left atrial access, positioning of ablation catheters and placement of mapping and ablation catheters for circumferential ablation
Intervention Type
Device
Intervention Name(s)
Steerable Sheath System
Other Intervention Name(s)
Vado Steerable Sheath
Intervention Description
The Vado™ Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible catheter positioning in the cardiac anatomy.
Primary Outcome Measure Information:
Title
Absence of adverse device related events at release from hospital post procedure per institutional standard of care
Description
Steerability and positioning to facilitate catheter placement
Time Frame
Procedure through 7 day clinical follow up
Secondary Outcome Measure Information:
Title
Hemostasis and Visibility of the steerable sheath
Description
Safe event free insertion of the steerable sheath system in the femoral vein
Time Frame
Procedure through 7 day clinical follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS Criteria.
Eighteen to Eighty years of age
Signed informed consent
Exclusion Criteria:
Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
Severe cerebrovascular disease or history of cerebrovascular event within one (1) month
Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29.
Active gastrointestinal bleeding, infection or fever (> 100.5/38C)
Severe co morbidity or Short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease
Structural heart disease of clinical significance including
Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing
Stable/unstable angina or ongoing myocardial ischemia
Myocardial infarction (MI) within three months of enrollment
Aortic or mitral valve disease > Grade II
Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
Enrollment in any other ongoing arrhythmia study protocol
Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
Active infection or sepsis
Female patient is pregnant or lactating
Untreatable allergy to contrast media
Any diagnosis of atrial fibrillation 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Crozier, MD
Organizational Affiliation
Christchurch Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Daly, MD
Organizational Affiliation
Christchurch Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
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.
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Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
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