Cardiac Vascular Reconstruction DynaCT for TAVI Procedures | NCT02031796

Studies
Cardiac Vascular Reconstruction DynaCT for TAVI Procedures

NCT02031796

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 8, 2019Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Aortic Valve Disease

Interventions

CAVAREC Image Processing algorithm

Countries

United States

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Oct 13, 2017Actual

Completion Date

Oct 17, 2017Actual

First Submitted Date

Jan 7, 2014

First Submission Date that Met QC Criteria

Jan 7, 2014

First Posted Date

Jan 9, 2014Estimated

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

Jan 4, 2019

Last Update Posted Date

Jan 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kenneth A. Fetterly, Ph.D., Principal Investigator, Mayo ClinicPrincipal Investigator

Lead Sponsor

Mayo ClinicOTHER

Collaborators

Name	Class
Siemens Medical Solutions USA - CSG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures or interventional procedures to treat congenital or structural heart disease. CAVAREC utilizes the same x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC will occur during the interventional procedure after the TAVI device, other valve, or stent is implanted. If the participants already have a surgically-implanted TAVI device, stent or other device, and are having a cardiac catheterization, then an extra set of images will be acquired after your clinical care is complete, but before you leave the procedure room. The CAVAREC image processing algorithm will be implemented on an off-line workstation after the interventional procedure is complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT and cardiac CT images from Radiology. The results of this study will be used to direct further development of CAVAREC toward the end goal of providing improved imaging capabilities to guide TAVI, congenital heart, or structural heart treatment procedures.

Detailed Description

Compare utility of CAVAREC to standard DynaCT and cardiac CT for clinical assessment of the aortic valve and relevant, nearby anatomical structures.
Investigate the utility of CAVAREC to assess calcification within and surrounding the native aortic valve.
Investigate the utility of CAVAREC to assess procedural success, including prosthetic valve placement and annular anatomic correlates of paravalvular leak.
Validate utility of CAVAREC for images acquired during normal sinus rhythm.

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

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAVAREC images	Experimental	CAVAREC images from x-ray angiography	Other: CAVAREC Image Processing algorithm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAVAREC Image Processing algorithm	Other	After deployment of the TAVI prosthesis, other trans catheter valve, or stent, but before the patient care episode is completed, a set of rotational x-ray angiography images will be acquired and reconstructed using the clinical DyanCT and research CAVAREC algorithms.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of images of the aortic valve that are accurate	Qualitative image assessment will be performed by Board Certified Cardiologists and/or Radiologists who are familiar with cardiac CT image manipulation and interpretation.	approx 2 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients may either be scheduled for a TAVI procedure or scheduled for a cath lab appointment at any time after a TAVI procedure, or scheduled for device implant to treat congenital or structural heart disease.

Exclusion Criteria:

Patient enrolled in research protocol with exclusions from simultaneous participation in another protocol
Lack of research consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Fetterly, Ph.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D000082862	Aortic Valve Disease

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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