Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000571572
Ethics application status
Approved
Date submitted
23/03/2024
Date registered
6/05/2024
Date last updated
6/05/2024
Date data sharing statement initially provided
6/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying patients suitable for same day discharge after Transcatheter Aortic Valve Implantation (NORTH SHORE DAY STAY TAVI)
Scientific title
Prospective observational study to accurately identify patients suitable for same day discharge after Transcatheter Aortic Valve Implantation in both self-expanding and balloon-expandable valves
Secondary ID [1] 311795 0
ERP-2021-12910
Universal Trial Number (UTN)
U1111-1305-9483
Trial acronym
NORTH SHORE DAY STAY TAVI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 333303 0
Transcatheter Aortic Valve Implantation 333304 0
Condition category
Condition code
Cardiovascular 329990 329990 0 0
Other cardiovascular diseases
Public Health 330123 330123 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to determine if the NORTH SHORE DAY STAY TAVI clinical pathway effectively identifies patients who are low-risk of post-procedural complications and suitable for same day discharge (SDD) after transfemoral Transcatheter Aortic Valve Implantation (TAVI).

As part of the study, the clinical pathway will be applied to all patients undergoing transfemoral elective TAVI procedures at the included study sites. The NORTH SHORE DAY STAY TAVI clinical pathway involves comprehensive preprocedural, intraprocedural and postprocedural assessments to identify suitable patients and assess for early signs of complications. Postprocedural assessment will occur at 4-6 hours after TAVI. During that assessment the physician will assign the patient as either being suitable (NORTH SHORE DAY-STAY TAVI Score = 0) or unsuitable (NORTH SHORE DAY-STAY TAVI Score >= 1) for same day discharge based on objective screening criteria.

Preprocedural requirements specified in the clinical pathway are non-urgent, elective TAVI, age greater than or equal to 18 years old, mobilising and living independently, adequate social supports to facilitate recovery at home and no significant medical comorbidities that necessitated additional in-hospital monitoring such as end stage renal disease or advanced dementia. Patients are additionally excluded if there was a right bundle branch block (RBBB) or atrioventricular block (AVB) on baseline ECG, unless the patient has a permanent pacemaker.

Procedural requirements include no general anaesthesia (conscious sedation or local anaesthetic only), no high-grade AVB during valve deployment, no recorded intraprocedural complications and temporary pacing wires removed at the end of the case.

Postprocedural requirements include: (1) no evidence of delirium, (2) no evidence of vascular access site complications such as haematoma or pseudoaneurysm, (3) no abnormal transthoracic echocardiogram features (LVEF > 30%, none or mild paravalvular leak, no new pericardial effusion and functioning implanted valve), (4) no new conduction abnormalities (new AVB including first degree block, or bundle branch block) unless the patient had a permanent pacemaker, (5) ability to mobilise 20 metres (assessed using the patient’s regular mobility aids) and (6) structural heart team review, together with patient and their family, to provide a final approval for SDD. A bedside duplex femoral ultrasound is the only additional assessment that is not part of standard care that will be required for included patients.

Patients that undergo SDD will then be discharged with in-person review in a clinic the following day. Patients will again be followed up at 30 days after their TAVI to assess for outcome measures including all-cause mortality, rehospitalization and other complications. Follow up will involve a 15-30 minute in-person clinic review or telephone interview (if there are logistic and travel constraints such as regional or interstate patients) for patients. An additional review of medical records by the Research team will be performed to corroborate data collected and ensure comprehensive assessment for adverse events. Review by the patients regular treating Cardiologist and repeat transthoracic echocardiogram at 30 days after TAVI that is required by the study is part of standard care. Collection of this data will be performed by the Research Team.

The following information will be collected for the study:
- Patient demographics and clinical information (medical history and medication history)
- Baseline clinical scores (quality of life measures, surgical risk score)
- Baseline and post TAVI blood tests (haemoglobin, creatinine, albumin)
- Pre and post TAVI echocardiograms (TTE)
- Pre and post TAVI ECGs
- CT (Computed Tomography) TAVI result (this is a pre-TAVI requirement, and is not an extra step of the research study)
- TAVI procedure details (valve type and/or any complications)
- Post-TAVI inpatient outcomes and clinical pathway score
- Adverse events and complications that may have occurred, until 1 month after TAVI
Intervention code [1] 328242 0
Early Detection / Screening
Comparator / control treatment
The comparator group will consist of patients initially included in the study that had a NORTH SHORE DAY-STAY TAVI Score >= 1, meaning they were unsuitable for same day discharge after TAVI. Comparison of outcomes between patients who underwent same day discharge (NORTH SHORE DAY-STAY TAVI Score = 0) and patients unsuitable for same day discharge, will indicate the safety and accuracy of the clinical pathway. Comparator group patients will have a minimum hospital stay of at least 1 night, with an average 1-3 nights length of stay in hospital.
Control group
Active

Outcomes
Primary outcome [1] 337756 0
Composite endpoint of all-cause mortality, stroke, major bleeding, major vascular complication, new renal replacement therapy and high-grade atrioventricular block
Timepoint [1] 337756 0
Index hospitalization
30 days after TAVI procedure
Secondary outcome [1] 433175 0
All cause mortality
Timepoint [1] 433175 0
30 days after TAVI procedure
Secondary outcome [2] 433176 0
Stroke
Timepoint [2] 433176 0
30 days after TAVI procedure
Secondary outcome [3] 433177 0
Major bleeding
Timepoint [3] 433177 0
30 days after TAVI procedure
Secondary outcome [4] 433178 0
Major vascular complication
Timepoint [4] 433178 0
30 days after TAVI procedure
Secondary outcome [5] 433179 0
High grade atrioventricular block
Timepoint [5] 433179 0
30 days after TAVI procedure
Secondary outcome [6] 433180 0
Renal replacement therapy
Timepoint [6] 433180 0
30 days after TAVI procedure
Secondary outcome [7] 433181 0
Rehospitalization
Timepoint [7] 433181 0
30 days after TAVI procedure

Eligibility
Key inclusion criteria
All patients undergoing elective, transfemoral TAVI procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inpatient or non-elective TAVI
- Non-transfemoral access

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The accuracy of the North Shore DAY-STAY TAVI Pathway will be reported as the area under the receiver operating characteristic curve (AUROC).

Rates of outcomes during index hospitalization and at 30-days will be reported as crude rates with 95% confidence intervals.
Categorical outcomes will be compared between the two groups using either chi-square tests or Fisher exact tests as appropriate. Baseline characteristics will be compared between the two groups using chi-square tests or Fisher exact tests for categorical outcomes, and the independent T-test or Wilcoxon Signed-Rank test for continuous outcomes as appropriate. The normality of continuous variables will be assessed using histogram analysis and the Shapiro-Wilk test. Due to the risk of confounding variables, a multivariate analysis will also be performed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/02/2024
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
59
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26300 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 26301 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 42273 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 316128 0
Hospital
Name [1] 316128 0
Department of Cardiology, Royal North Shore Hospital
Country [1] 316128 0
Australia
Funding source category [2] 316129 0
Charities/Societies/Foundations
Name [2] 316129 0
Heart Research Australia
Country [2] 316129 0
Australia
Funding source category [3] 316130 0
Commercial sector/Industry
Name [3] 316130 0
Medtronic Australia
Country [3] 316130 0
Australia
Primary sponsor type
Hospital
Name
Department of Cardiology, Royal North Shore Hospital
Address
Country
Australia
Secondary sponsor category [1] 318306 0
None
Name [1] 318306 0
Address [1] 318306 0
Country [1] 318306 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314958 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314958 0
https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
Ethics committee country [1] 314958 0
Australia
Date submitted for ethics approval [1] 314958 0
Approval date [1] 314958 0
09/02/2023
Ethics approval number [1] 314958 0
2022/ETH02311 & 2022/ETH02312

Summary
Brief summary
Next day discharge after transcatheter aortic valve implantation (TAVI) has been shown to be safe and is now commonly implemented in clinical practice. A small number of studies have investigated same day discharge (SDD) after TAVI, but more studies are needed, particularly in self-expanding valves. This study will prospectively apply a locally derived discharge protocol to all consecutive patients undergoing elective, transfemoral TAVI procedures at our centres. The study aims to determine if the NORTH SHORE DAY-STAY TAVI clinical pathway effectively identifies patients who are at low risk of post-procedural complications and to evaluate if they can be safely discharged on the same day following transfemoral transcatheter aortic valve implantation (tf-TAVI). The project will measure endpoints including all-cause mortality, stroke, major bleeding, major vascular complication, new renal replacement therapy and high-grade AV block during index hospitalization and at 30-day follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133250 0
Prof Ravinay Bhindi
Address 133250 0
Cardiology Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 133250 0
Australia
Phone 133250 0
+61294632522
Fax 133250 0
Email 133250 0
ravinay.bhindi@sydney.edu.au
Contact person for public queries
Name 133251 0
Ravinay Bhindi
Address 133251 0
Cardiology Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 133251 0
Australia
Phone 133251 0
+61294632522
Fax 133251 0
Email 133251 0
ravinay.bhindi@sydney.edu.au
Contact person for scientific queries
Name 133252 0
Ravinay Bhindi
Address 133252 0
Cardiology Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 133252 0
Australia
Phone 133252 0
+61294632522
Fax 133252 0
Email 133252 0
ravinay.bhindi@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.