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The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement (3MTAVR)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02287662
First Posted: November 11, 2014
Last Update Posted: September 25, 2017
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. Read our disclaimer for details.
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
BC Centre for Improved Cardiovascular Health
  Purpose
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge hime in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.

Condition Intervention
Aortic Valve Stenosis Other: Vancouver 3M Clinical Pathway

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Vancouver Multidisciplinary, Multimodality, But Minimalist Clinical Pathway Facilitates Safe Next Day Discharge Home at Low, Medium, and High Volume Transfemoral Transcatheter Aortic Valve Replacement Centres: The 3M TAVR Study

Resource links provided by NLM:


Further study details as provided by BC Centre for Improved Cardiovascular Health:

Primary Outcome Measures:
  • The composite of all-cause mortality or stroke [ Time Frame: 30 days post-procedure ]
  • The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day [ Time Frame: Next day ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 days post-procedure ]
  • Stroke [ Time Frame: 30 days post-procedure ]
  • 30-day major vascular complications [ Time Frame: 30 days post-procedure ]
  • 30-day major/life-threatening bleed [ Time Frame: 30 days post-procedure ]
  • Any readmission to hospital within 30 days [ Time Frame: 30 days post-procedure ]
  • > mild paravalvular regurgitation [ Time Frame: Post-procedure/discharge ]
  • New permanent pacemaker [ Time Frame: 30 days post-procedure ]
  • Conversion to general anesthetic/intubation [ Time Frame: Peri-procedure ]
  • Myocardial infarction [ Time Frame: Peri-procedure ]
  • Repeat procedure for valve-related dysfunction [ Time Frame: 30 days post-procedure ]
  • Stage 3 acute kidney injury (need for dialysis) [ Time Frame: 30 days post-procedure ]
  • Patient-centred outcomes including health related quality of life as measured by KCCQ and SF-12 at baseline, 2 weeks, 30 days, and 1 year [ Time Frame: Baseline, and 2 weeks, 30 day and 1 year post procedure ]
  • Economic evaluation including health resource utilization, and cost effectiveness [ Time Frame: Peri- and post-procedure ]
  • Death or stroke at one year [ Time Frame: 1 year post-procedure ]

Estimated Enrollment: 411
Actual Study Start Date: March 2015
Estimated Study Completion Date: May 2018
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vancouver 3M Clinical Pathway
The Vancouver 3M 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 3M Clinical Pathway

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a balloon expandable 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. Iliofemoral diameter < 6 mm for SAPIEN XT or <5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head)
  6. Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons.
  7. Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions
  8. MMSE < 24/30 (unless language barrier or limited formal education), 5-metre gait > 7 seconds (unless chronic mobility impairment not affecting ability to perform ADLs), and ADL < 6/6
  9. Insufficient social support to facilitate next day discharge
  10. Airway unfavourable for emergent intubation
  11. Inability to lay supine without conscious sedation or general anesthetic
  12. Not receiving a balloon expandable transcatheter heart valve
  Contacts and Locations
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): NCT02287662


Locations
Canada, British Columbia
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Sponsors and Collaborators
BC Centre for Improved Cardiovascular Health
University of British Columbia
Investigators
Principal Investigator: David A Wood, MD University of British Columbia
Principal Investigator: John A Webb, MD University of British Columbia
  More Information

Responsible Party: BC Centre for Improved Cardiovascular Health
ClinicalTrials.gov Identifier: NCT02287662     History of Changes
First Submitted: November 6, 2014
First Posted: November 11, 2014
Last Update Posted: September 25, 2017
Last Verified: August 2017

Keywords provided by BC Centre for Improved Cardiovascular Health:
Transcatheter Aortic Valve Replacement

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