Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521896
• Other study ID #: CP1-001
• Status: Completed
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 10, 2015
• Start date: August 2014
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: Kalila Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Steerable Sheath System
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kalila Medical

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of adverse device related events at release from hospital post procedure per institutional standard of care	Steerability and positioning to facilitate catheter placement	Procedure through 7 day clinical follow up	No
Secondary	Hemostasis and Visibility of the steerable sheath	Safe event free insertion of the steerable sheath system in the femoral vein	Procedure through 7 day clinical follow up	No