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Trial record 1 of 1 for:    NCT03600935
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Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement (SAFETAVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03600935
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : September 25, 2018
University of British Columbia
Information provided by (Responsible Party):
BC Centre for Improved Cardiovascular Health

Brief Summary:
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Other: Vancouver Clinical Pathway Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vancouver Clinical Pathway
The Vancouver Clinical Pathway utilizes objective anatomical and functional screening criteria as well as strict peri-procedural guidelines to determine if next day discharge home is appropriate.
Other: Vancouver Clinical Pathway
Vancouver Clinical Pathway

Primary Outcome Measures :
  1. The composite of all-cause mortality or stroke [ Time Frame: 30 days post-procedure ]
  2. The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day [ Time Frame: Discharge 1 day after procedure ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days post-procedure ]
  2. Stroke [ Time Frame: 30 days post-procedure ]
  3. Major vascular complications [ Time Frame: 30 days post-procedure ]
  4. Major/Life-threatening bleed [ Time Frame: 30 days post-procedure ]
  5. Any hospital readmission [ Time Frame: 30 days post-procedure ]
  6. >mild paravalvular regurgiation [ Time Frame: Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure ]
  7. New permanent pacemaker [ Time Frame: 30 days post-procedure ]
  8. Patient is converted from local to general anaesthetic/receives intubation during procedure [ Time Frame: This happens during the procedure ]
  9. Myocardial infarction [ Time Frame: This happens during the procedure ]
  10. Repeat procedure for valve-related dysfunction [ Time Frame: 30 days post-procedure ]
  11. Stage 3 acute kidney injury (need for dialysis) [ Time Frame: 30 days post-procedure ]
  12. Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year [ Time Frame: Baseline, and 30 days and 1 year post-procedure ]

Other Outcome Measures:
  1. Death or stroke [ Time Frame: 1 year post-procedure ]

Information from the National Library of Medicine

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

Inclusion Criteria:

Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve

  1. Considered at increased surgical risk by the Multidisciplinary Heart Team
  2. Informed written consent

Exclusion Criteria:

  1. Non-cardiovascular co-morbidity reducing life expectancy to <3 years
  2. Any factor precluding 1 year follow-up
  3. Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)
  4. Predicted inability to perform uncomplicated percutaneous vascular access and closure
  5. Illiofemoral diameter <6 mm (for 23 and 25 mm valves) and <6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head
  6. Surgical prosthesis <23 mm (labelled size) for valve-in-valve procedure
  7. In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
  8. Language barriers (inability to understand peri-procedural and discharge instructions)
  9. Insufficient social support post procedure to allow next day discharge
  10. Airway unfavourable for emergent intubation
  11. Inability to lay supine without conscious sedation or general anaesthetic

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 identifier (NCT number): NCT03600935

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Contact: David A Wood, MD 6048755601
Contact: Shirley C Wong, PhD 6046822344 ext 65676

Sponsors and Collaborators
BC Centre for Improved Cardiovascular Health
University of British Columbia
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Principal Investigator: David A Wood, MD University of British Columbia
Principal Investigator: John A Webb, MD University of British Columbia
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Responsible Party: BC Centre for Improved Cardiovascular Health Identifier: NCT03600935    
Other Study ID Numbers: TBD1
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BC Centre for Improved Cardiovascular Health:
Transcatheter Aortic Valve Replacement
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction