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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Steerable Sheath System

• Registration Number: NCT02521896
• Lead Sponsor: Kalila Medical

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2015-08
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-10
• Last Update Submitted: 2015-08-10
• Study First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Steerable sheath for intracardiac access	Steerable Sheath System	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

Primary Outcome Measures

Name	Time	Method
Absence of adverse device related events at release from hospital post procedure per institutional standard of care	Procedure through 7 day clinical follow up	Steerability and positioning to facilitate catheter placement

Secondary Outcome Measures

Name	Time	Method
Hemostasis and Visibility of the steerable sheath	Procedure through 7 day clinical follow up	Safe event free insertion of the steerable sheath system in the femoral vein