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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03291925
Other study ID # ICVHealth2016002
Secondary ID
Status Recruiting
Phase N/A
First received March 28, 2017
Last updated September 20, 2017
Start date November 2016
Est. completion date September 2019

Study information

Verified date September 2017
Source BC Centre for Improved Cardiovascular Health
Contact Shirley Wong, PhD
Phone 604-682-2344
Email 3M@icvhealth.ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Procedure/Surgery: Invasive angiography


Locations

Country Name City State
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
BC Centre for Improved Cardiovascular Health Edwards Lifesciences

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 All-cause mortality 90 days
Secondary Myocardial Infarction According to Valvular Academic Research Consortium-2 (VARC-2) criteria.
Periprocedural MI (=72h post procedure).
Spontaneous MI.
Peri-procedural (=72h post procedure) and 90 days
Secondary Unplanned revascularization Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure. 90 days
Secondary Bleeding complication According to VARC-2 criteria.
TAVI related = 72h post TAVI
Coronary procedure related = 72h post CA or PCI (if staged TAVI-PCI)
Peri-procedural (=72h post procedure) and 90 days
Secondary Device success According to VARC-2 criteria. 90 days
Secondary Acute Kidney Injury According to VARC-2 criteria. 90 days
Secondary Stroke An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as assessed by a clinician and confirmed by at least one cerebral imaging study (CT or MRI). Stroke may be classified as ischaemic or haemorrhagic 90 days
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