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

Not Applicable

• Conditions: Transcatheter Aortic Valve Implantation; Severe Aortic Stenosis

• Registration Number: NCT03291925
• Lead Sponsor: BC Centre for Improved Cardiovascular Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-03-28
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-20
• Last Update Submitted: 2017-09-20
• Study First Posted: 2017-09-25
• Last Update Posted: 2017-09-25
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients enrolled in the study of all those that are eligible	18 months	This is the primary outcome for this pilot study to assess feasibility of a larger trial.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	90 days
Myocardial Infarction	Peri-procedural (≤72h post procedure) and 90 days	According to Valvular Academic Research Consortium-2 (VARC-2) criteria.; * Periprocedural MI (≤72h post procedure).; * Spontaneous MI.
Unplanned revascularization	90 days	Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.
Bleeding complication	Peri-procedural (≤72h post procedure) and 90 days	According to VARC-2 criteria.; * TAVI related ≤ 72h post TAVI; * Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI)
Device success	90 days	According to VARC-2 criteria.
Acute Kidney Injury	90 days	According to VARC-2 criteria.
Stroke	90 days	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

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada