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

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ClinicalTrials.gov Identifier: NCT03291925
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Severe Aortic Stenosis Transcatheter Aortic Valve Implantation Procedure: Selective invasive angiography based on CT/CCTA imaging. Procedure: Procedure/Surgery: Invasive angiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open-label trial.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)
Study Start Date : November 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

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



Primary Outcome Measures :
  1. Number of patients enrolled in the study of all those that are eligible [ Time Frame: 18 months ]
    This is the primary outcome for this pilot study to assess feasibility of a larger trial.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 90 days ]
  2. Myocardial Infarction [ Time Frame: 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.

  3. Unplanned revascularization [ Time Frame: 90 days ]
    Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.

  4. Bleeding complication [ Time Frame: 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)

  5. Device success [ Time Frame: 90 days ]
    According to VARC-2 criteria.

  6. Acute Kidney Injury [ Time Frame: 90 days ]
    According to VARC-2 criteria.

  7. Stroke [ Time Frame: 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291925


Contacts
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Contact: Shirley Wong, PhD 604-682-2344 3M@icvhealth.ubc.ca

Locations
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Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Contact: Shirley Wong, PhD    604-682-2344 ext 65676    3M@icvhealth.ubc.ca   
Principal Investigator: Leipsic Jonathon, MD         
Sponsors and Collaborators
BC Centre for Improved Cardiovascular Health
Edwards Lifesciences
Investigators
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Principal Investigator: Jonathon Leipsic, MD St. Paul's Hospital

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Responsible Party: BC Centre for Improved Cardiovascular Health
ClinicalTrials.gov Identifier: NCT03291925     History of Changes
Other Study ID Numbers: ICVHealth2016002
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction