Safety and Efficacy Study of the Cardiapex Percutaneous T... | NCT01722591

Studies
Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System

NCT01722591

Sponsor

Cardiapex Ltd.

Status

Terminated

Last Update Posted

Feb 4, 2015Estimated

Enrollment

38Estimated

Phase

Not Applicable

Conditions

Transapical Transcatheter Aortic Valve Implantation

Interventions

Cardiapex device

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Not provided

First Submitted Date

Nov 2, 2012

First Submission Date that Met QC Criteria

Nov 5, 2012

First Posted Date

Nov 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiapex device	Experimental	Use of the Cardiapex device in the context of transapical TAVI procedures	Device: Cardiapex device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiapex device	Device	Cardiapex percutaneous transapical access and closure system	Cardiapex device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"		Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours

Secondary Outcomes

Measure	Description	Time Frame
≤30 day apical bleeding requiring surgical intervention		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient scheduled for transapical TAVI
Patient ≥ 70 years of age
Patient able to give informed written consent
Patient able to attend follow up examinations

Exclusion Criteria:

Scheduled concomitant non-TAVI cardiac procedure
Patient with Left Ventricular Ejection Fraction (LVEF) < 30% at time of enrollment
Patient with known apical infarcted area
Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
Patient with contra-indications to transapical TAVI
Patient's inability to tolerate or comply with normal post-surgical drug regimen
Patient's inability to comply with required follow-ups, including echocardiography
Patient participation in other clinical trials within previous month

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kerckhoff Clinic		Bad Nauheim			Germany
Hamburg University Heart Center