NCT03291925

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

March 28, 2017

Last Update Submit

September 20, 2017

Conditions

Severe Aortic StenosisTranscatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (1)

  • Number of patients enrolled in the study of all those that are eligible

    This is the primary outcome for this pilot study to assess feasibility of a larger trial.

    18 months

Secondary Outcomes (7)

  • All-cause mortality

    90 days

  • Myocardial Infarction

    Peri-procedural (≤72h post procedure) and 90 days

  • Unplanned revascularization

    90 days

  • Bleeding complication

    Peri-procedural (≤72h post procedure) and 90 days

  • Device success

    90 days

  • +2 more secondary outcomes

Study Arms (2)

Selective invasive angiography based on CT/CCTA imaging

EXPERIMENTAL

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.

Procedure: Selective invasive angiography based on CT/CCTA imaging.

Invasive Cardiac Angiography

ACTIVE COMPARATOR

Patients will undergo systematic invasive angiography.

Procedure: Procedure/Surgery: Invasive angiography

Interventions

Selective invasive angiography based on CT/CCTA imaging.PROCEDURE
Selective invasive angiography based on CT/CCTA imaging
Procedure/Surgery: Invasive angiographyPROCEDURE
Invasive Cardiac Angiography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jonathon Leipsic, MD

    St. Paul's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Wong, PhD

CONTACT

604-682-23443M@icvhealth.ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, randomized, open-label trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

September 25, 2017

Study Start

November 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)