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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized, open-label trial.|
|Masking:||None (Open Label)|
|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|
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
- 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.
- All-cause mortality [ Time Frame: 90 days ]
- 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.
- 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.
- 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)
- Device success [ Time Frame: 90 days ]According to VARC-2 criteria.
- Acute Kidney Injury [ Time Frame: 90 days ]According to VARC-2 criteria.
- 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
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
|Contact: Shirley Wong, PhD||604-682-2344||3M@icvhealth.ubc.ca|
|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|
|Principal Investigator:||Jonathon Leipsic, MD||St. Paul's Hospital|