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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

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02521896

First Posted

August 6, 2015

Last Updated

August 10, 2015

Sponsor

Kalila Medical

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

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

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

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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