Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI (CT-CA)

Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)

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.

Study Overview

• Status: Unknown
• Conditions: Transcatheter Aortic Valve Implantation; Severe Aortic Stenosis
• Intervention / Treatment: Procedure: Selective invasive angiography based on CT/CCTA imaging.; Procedure: Procedure/Surgery: Invasive angiography

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shirley Wong, PhD; Phone Number: 604-682-2344; Email: 3M@icvhealth.ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • Recruiting
      • St. Paul's Hospital
      • Contact: Shirley Wong, PhD; Phone Number: 65676 604-682-2344; Email: 3M@icvhealth.ubc.ca
      • Principal Investigator: Leipsic Jonathon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Selective invasive angiography based on CT/CCTA imaging.
Active Comparator: Invasive Cardiac Angiography; Patients will undergo systematic invasive angiography.	Procedure: Procedure/Surgery: Invasive angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		90 days
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
Unplanned revascularization	Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.	90 days
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
Device success	According to VARC-2 criteria.	90 days
Acute Kidney Injury	According to VARC-2 criteria.	90 days
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

Collaborators and Investigators

• Sponsor: BC Centre for Improved Cardiovascular Health
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Jonathon Leipsic, MD, St. Paul's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: ICVHealth2016002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO