The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

— 3MTAVR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287662
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: BC Centre for Improved Cardiovascular Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: May 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Other:
• Vancouver 3M Clinical Pathway

Locations

Country	Name	City	State
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
BC Centre for Improved Cardiovascular Health	University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of all-cause mortality or stroke		30 days post-procedure
Primary	The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day		Next day
Secondary	All-cause mortality		30 days post-procedure
Secondary	Stroke		30 days post-procedure
Secondary	30-day major vascular complications		30 days post-procedure
Secondary	30-day major/life-threatening bleed		30 days post-procedure
Secondary	Any readmission to hospital within 30 days		30 days post-procedure
Secondary	> mild paravalvular regurgitation		Post-procedure/discharge
Secondary	New permanent pacemaker		30 days post-procedure
Secondary	Conversion to general anesthetic/intubation		Peri-procedure
Secondary	Myocardial infarction		Peri-procedure
Secondary	Repeat procedure for valve-related dysfunction		30 days post-procedure
Secondary	Stage 3 acute kidney injury (need for dialysis)		30 days post-procedure
Secondary	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		Baseline, and 2 weeks, 30 day and 1 year post procedure
Secondary	Economic evaluation including health resource utilization, and cost effectiveness		Peri- and post-procedure
Secondary	Death or stroke at one year		1 year post-procedure