Atrial FibrillationNCT02521896
Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
A study testing Steerable Sheath System in people with Atrial Fibrillation, run by Kalila Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Steerable Sheath System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jan 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS Criteria.
- Eighteen to Eighty years of age
- Signed informed consent
Who cannot join
- 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
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- 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)
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Steerable Sheath System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steerable Sheath SystemDevice
Also called Vado Steerable Sheath
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.
| Study group | Role | What they receive |
|---|---|---|
| Steerable sheath for intracardiac access | Experimental | 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 Receives: Device: Steerable Sheath System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of adverse device related events at release from hospital post procedure per institutional standard of care
Steerability and positioning to facilitate catheter placement
Measured: Procedure through 7 day clinical follow up
Secondary outcomes (1)
Hemostasis and Visibility of the steerable sheath
Safe event free insertion of the steerable sheath system in the femoral vein
Measured: Procedure through 7 day clinical follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kalila Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Crozier, MD, Principal investigator, Christchurch HospitalMatthew Daly, MD, Principal investigator, Christchurch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521896
- Sponsor's protocol ID
- CP1-001
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02521896
- Acronym / sponsor ID
- CP1-001
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kalila MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Aug 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steerable sheath for intracardiac access | Experimental | Device: Steerable Sheath SystemVado 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS Criteria.
- Eighteen to Eighty years of age
- Signed informed consent
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| Steerable Sheath SystemAlso: Vado Steerable SheathThe 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. | Device | Steerable sheath for intracardiac access |
Primary outcome
Absence of adverse device related events at release from hospital post procedure per institutional standard of care
Time frame: Procedure through 7 day clinical follow up
Steerability and positioning to facilitate catheter placement
1 secondary outcome
Hemostasis and Visibility of the steerable sheath
Time frame: Procedure through 7 day clinical follow up
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 13 Aug 2015.
- Background: 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.
Ian Crozier, MD principal investigator
Christchurch Hospital
Matthew Daly, MD principal investigator
Christchurch Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Steerable Sheath System in people with Atrial Fibrillation, run by Kalila Medical.
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 20 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Absence of adverse device related events at release from hospital post procedure per institutional standard of care (time frame: Procedure through 7 day clinical follow up). 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 NCT02521896, which also lists 1 linked publication.
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 13 Aug 2015.