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

NCT02521896 | Completed

• 1 other identifier: CP1-001
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Hemostasis and Visibility of the steerable sheath

  Procedure through 7 day clinical follow up

Study Arms (1)

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

Device: Steerable Sheath System

Interventions

Steerable Sheath System DEVICE

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.

Also known as: Vado Steerable Sheath

Steerable sheath for intracardiac access

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS Criteria.
• Eighteen to Eighty years of age
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Kalila Medical: lead

Related 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.

  PMID: 21248246 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Crozier, MD

  Christchurch Hospital

  PRINCIPAL INVESTIGATOR

• Matthew Daly, MD

  Christchurch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08