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

Transcatheter Aortic Valve Implantation Clinical Trial

— CT-CA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03291925
• Other study ID #: ICVHealth2016002
• 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
• 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).

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Aortic Stenosis
• Transcatheter Aortic Valve Implantation

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