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Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI

NCT ID: NCT03291925

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-09-30

Brief Summary

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This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.

Detailed Description

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Conditions

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Severe Aortic Stenosis Transcatheter Aortic Valve Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, open-label trial.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Selective invasive angiography based on CT/CCTA imaging

Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease.

Group Type EXPERIMENTAL

Selective invasive angiography based on CT/CCTA imaging.

Intervention Type PROCEDURE

Invasive Cardiac Angiography

Patients will undergo systematic invasive angiography.

Group Type ACTIVE_COMPARATOR

Procedure/Surgery: Invasive angiography

Intervention Type PROCEDURE

Interventions

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Selective invasive angiography based on CT/CCTA imaging.

Intervention Type PROCEDURE

Procedure/Surgery: Invasive angiography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo, Aortic valve area of \< 1.0cm2)
* Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina)
* Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least one interventional cardiologist and one cardiothoracic surgeon)

Exclusion Criteria

* Severe renal dysfunction Glomerular filtration rate \< 30 ml/min.
* Severe left ventricular dysfunction LVEF ≤ 30%
* Recent coronary angiography ≤ 6months from randomization
* Recent PCI ≤ 6months from randomization
* Recent or active acute coronary syndrome (New or worsening angina with or without positive biomarkers or ECG changes).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

BC Centre for Improved Cardiovascular Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathon Leipsic, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Shirley Wong, PhD

Role: CONTACT

[email protected]
604-682-2344

Facility Contacts

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Shirley Wong, PhD

Role: primary

[email protected]
604-682-2344 ext. 65676

Other Identifiers

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ICVHealth2016002

Identifier Type: -

Identifier Source: org_study_id