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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05002088




Registration number
NCT05002088
Ethics application status
Date submitted
27/07/2021
Date registered
12/08/2021
Date last updated
9/02/2024

Titles & IDs
Public title
Portico Valve-in-Valve Retrospective Registry
Scientific title
Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use
Secondary ID [1] 0 0
ABBOTT-CIP-10414
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Aortic Valve Failure 0 0
Aortic Insufficiency 0 0
Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Transcatheter Aortic Valve Replacement

Primary Analysis Population - The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (=19 mm and =27 mm).

Exploratory Registry Arm - The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm.


Treatment: Devices: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The rate of all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complication adverse events at 30-days post-procedure.
Timepoint [1] 0 0
30 days post index procedure
Primary outcome [2] 0 0
The rate of all-cause mortality and disabling stroke adverse events at 1-year post-procedure.
Timepoint [2] 0 0
1 year post index procedure
Secondary outcome [1] 0 0
Procedure Success (descriptive endpoint)
Timepoint [1] 0 0
Procedure
Secondary outcome [2] 0 0
Evaluation of adverse event rates (descriptive endpoint)
Timepoint [2] 0 0
30 days post index procedure
Secondary outcome [3] 0 0
Evaluation of adverse event rates (descriptive endpoint)
Timepoint [3] 0 0
1 year post index procedure
Secondary outcome [4] 0 0
Evaluation of adverse event rates (descriptive endpoint)
Timepoint [4] 0 0
2 years post index procedure
Secondary outcome [5] 0 0
Evaluation of adverse event rates (descriptive endpoint)
Timepoint [5] 0 0
3 years post index procedure
Secondary outcome [6] 0 0
Evaluation of adverse event rates (descriptive endpoint)
Timepoint [6] 0 0
4 years post index procedure
Secondary outcome [7] 0 0
Evaluation of adverse event rates (descriptive endpoint)
Timepoint [7] 0 0
5 years post index procedure
Secondary outcome [8] 0 0
Clinical Benefit Endpoint
Timepoint [8] 0 0
30 days post index procedure
Secondary outcome [9] 0 0
Clinical Benefit Endpoint
Timepoint [9] 0 0
1 year post index procedure
Secondary outcome [10] 0 0
Clinical Benefit Endpoint
Timepoint [10] 0 0
2 years post index procedure
Secondary outcome [11] 0 0
Clinical Benefit Endpoint
Timepoint [11] 0 0
3 years post index procedure
Secondary outcome [12] 0 0
Clinical Benefit Endpoint
Timepoint [12] 0 0
4 years post index procedure
Secondary outcome [13] 0 0
Clinical Benefit Endpoint
Timepoint [13] 0 0
5 years post index procedure

Eligibility
Key inclusion criteria
1. Subject had a degenerated surgical aortic bioprosthetic valve with severe aortic
stenosis, severe regurgitation, or a combination of at least moderate stenosis with at
least moderate regurgitation per EAPCI-ESC-EACTS standardized criteria.

2. Surgical bioprosthesis true inner diameter (true ID) was = 19 mm and = 27 mm and was
confirmed by either CT or confirmed by the Valve in Valve Aortic App. Refer to the PCR
website
https://www.pcronline.com/PCR-Publications/PCR-mobile-apps/Valve-in-Valve-Aortic-app
Note: if CT was contraindicated and/or not possible to be obtained, a transesophageal
echocardiogram (TEE) will be accepted for sizing.

3. Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery
to replace the surgical aortic bioprosthetic valve.

4. Subject provided written informed consent prior to performing data collection for
study specific visits. For patients that are deceased at the time of enrollment, all
institutional/local legal and regulatory requirements for consent must be met prior to
enrollment and data collection.

5. Subject is = 18 years of age or legal age in host country at the time of consent.

6. Prior to the Portico ViV index procedure, the subject had New York Heart Association
(NYHA) class II, III, or IV.

7. Subject had a minimum vessel diameter of 6.0 mm for Portico™ delivery system access or
a minimum of 5.0 mm for the FlexNav™ delivery system.

8. Subject had the Portico or FlexNav delivery system enter their vasculature
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject had evidence of an acute MI, percutaneous intervention, or a peripheral
intervention =30 days prior to Portico ViV index procedure (MI defined as: ST Segment
Elevation as evidenced on 12 Lead ECG).

2. Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC<3,000 mm3),
acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <50,000 cells/mm³).

3. Subject was considered hemodynamically unstable at the time of the ViV procedure
(requiring inotropic support or mechanical heart assistance)

4. Subject had severe ventricular dysfunction with left ventricular ejection fraction
(LVEF) <20% as measured by resting echocardiogram.

5. Subject had imaging evidence of intracardiac mass, thrombus or vegetation.

6. Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding =3
months prior to ViV index procedure.

7. Subject had a documented history of a cerebrovascular accident (CVA) or a transient
ischemic attack (TIA) =6 months prior to index procedure.

8. Subject had renal insufficiency (serum creatinine >3.0 mg/dL (265.5µmol/L)) and/or end
stage renal disease requiring chronic dialysis.

9. Subject had active bacterial endocarditis or ongoing sepsis = 6 months prior to the
index procedure.

10. Surgical aortic bioprosthetic valve was unstable or rocking.

11. Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification)
that made insertion and endovascular access to the aortic valve impossible.

12. Subject was unable to tolerate antiplatelet or anticoagulant therapy

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/12/2023
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital - Adelaide
Recruitment hospital [2] 0 0
GenesisCare - Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
QLD 4066 - Auchenflower
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
Germany
State/province [2] 0 0
Bad Nauheim
Country [3] 0 0
Germany
State/province [3] 0 0
Rostock
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Morriston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this data-collection study is to retrospectively evaluate the safety and
clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment
of a failed aortic surgical bioprosthetic valve in patients who are considered at increased
surgical risk for a redo surgical aortic valve replacement.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05002088
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vinny Podichetty
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05002088