A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications

A Single Center, Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation

This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.

Study Overview

• Status: Completed
• Conditions: Vascular Access Complication

Detailed Description

This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route.

In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Montreal, Ontario, Canada
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of subjects with severe aortic stenosis who underwent TAVI utilizing the SoloPath sheath for vascular access since 2011.

Description

Inclusion Criteria:

1. Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath.
2. Male or female ≥ 18 years old.

Exclusion Criteria:

1. Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded.
2. Subjects treated before January 1, 2011, are excluded from this analysis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SoloPath Sheath; The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular Access Site Complications	Rate of VARC-2 defined vascular complications within 30 days of TAVI.	withn 30 days of TAVI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Complications at the Access Site	VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding	within 30 days of TAVI procedure

Collaborators and Investigators

• Sponsor: Terumo Medical Corporation
• Collaborators: Montreal Heart Institute
• Investigators: Principal Investigator: Anita Asagr, M.D., Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: January 21, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: TIS2014-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No