Symptomatic Degenerative Aortic StenosisNCT03752866
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
A study testing Portico™ Valve, Portico Delivery System(s) and Loading System(s) and Portico™ Valve, FlexNav Delivery System(s) and Loading System(s) in people with Symptomatic Degenerative Aortic Stenosis and Severe Aortic Stenosis, run by Abbott Medical Devices at 28 sites in 9 countries.
Trial summary
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
- What is being tested?
- Portico™ Valve, Portico Delivery System(s) and Loading System(s) and Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- 28 sitesin 9 countries
- Study dates
- 25 Oct 2018to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
- Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
Who cannot join
- Have sepsis, including active endocarditis
- Have any evidence of left ventricular or atrial thrombus
- Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
- Have a non-calcified aortic annulus
- Have congenital bicuspid or unicuspid leaflet configuration
- Are unable to tolerate antiplatelet/anticoagulant therapy
- Are pregnant at the time of signing informed consent
- Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
Germany11 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim, 61231
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
Berlin, 10117
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, 12203
St.-Johannes-Hospital
Dortmund, 44137
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 01307
Kliniken der Friedrich-Alexander-Universitat
Erlangen, Bavaria, 91054
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, 60590
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg, 20246
Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV
Karlsruhe, 76133
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Charite Campus Virchow Klinikum
Mitte, 13353
Italy4 sites
Ospedale San Raffaele
Milan, 20132
Policlinico di Monza
Monza, Lombardy, 20900
Policlinico San Donato
San Donato Milanese, 20097
Ospedale San Bortolo
Vicenza, 36100
Spain4 sites
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalonia, 08025
Hospital General Juan Ramon Jimenez
Huelva, 21005
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Puerta de Hierro
Madrid, 28222
United Kingdom4 sites
Royal Victoria Hospital
Belfast, Ireland, BT12 6BA
King's College Hospital
London, SE5 9RS
James Cook University Hoospital
Middlesbrough, North East England, TS4 3BW
Morriston Hospital - ABM University Health Board
Morriston, Swansea, SA6 6NL
Australia1 site
Heart Care Partners- Wesley Hospital
Woolloongabba, Queensland, 4102
Poland1 site
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, Masovian Voivodeship, 02-097
About this study
Official title: CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
Read the detailed description
The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.
Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.
The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
- Being tested
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Keywords
- Portico™ valve, Portico™ valve delivery system, Portico™ valve loading system, Transcatheter Aortic Valve Replacement, Aortic Stenosis, Heart Valve Prosthesis, TAVR, TAVR Registry, Transcatheter Aortic Valve Implant, TAVI, TAVI Registry, FlexNav delivery system, FlexNav loading system
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portico™ Valve, Portico Delivery System(s) and Loading System(s)Device
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)Device
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
| Study group | Role | What they receive |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Experimental | Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system will be included. Receives: Device: Portico™ Valve, Portico Delivery System(s) and Loading System(s) |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Experimental | Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems will be included. Receives: Device: Portico™ Valve, FlexNav Delivery System(s) and Loading System(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Mortality
Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
Measured: 30 days from the index procedure
Secondary outcomes (20)
Number of Subjects With Myocardial Infarction
Measured: At 30 days
Number of Subjects With Stroke
Measured: At 30 days
Number of Subjects With Bleeding Events
Measured: At 30 days
Number of Subjects With Acute Kidney Injury
The increase in creatinine must occur within 48 hours.
Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output <0.5 mL/kg per hour for >6 but <12 hours.
Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output <0.5 mL/kg per hour for >12 but <24 hours.
Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.
Measured: At 30 days
Number of Subjects With Vascular Complications
Measured: At 30 days
Number of Subjects With Annular Rupture
Measured: At 30 days
Number of Subjects With Coronary Obstruction
Measured: At 30 days
Number of Subjects Undergoing Conversion To Open Surgery
Measured: At 30 days
Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment
Measured: At 30 days
Number Of Subjects With Valve Embolization
Measured: At 30 days
Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion
Measured: At 30 days
Vessel Diameter
Measured: At 30 days
Introducer Sheath Used
This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).
Measured: At 30 days
Implant Success
Measured: At 30 days
Effective Orifice Area
Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.
Measured: At 30 days
Aortic Valve Mean Gradient
Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.
Measured: At 30 days
Number of Subjects With Paravalvular Leak (PVL)
Measured: At 30 days
NYHA Classification
NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below:
Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath.
Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV).
Measured: At 30 days
EQ5D-3L Visual Analog Scale Value
The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state."
Measured: At 30 days
Kaplan-Meier Rate of All-cause Mortality
Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start25 Oct 2018
- Primary completion2 Nov 2021
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Degenerative Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.
- Masking
- None (open label)
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helge Möllmann, Principal investigator, St. Johannes Hospital, Dortmund, GermanyVinny Podichetty, Study director, Abbott Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752866
- Sponsor's protocol ID
- SJM-CIP-CL1003491
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2018
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mollmann H, Linke A, Nombela-Franco L, Sluka M, Francisco Oteo Dominguez J, Montorfano M, Kim WK, Arnold M, Vasa-Nicotera M, Fichtlscherer S, Conradi L, Camuglia A, Bedogni F, Kohli K, Manoharan G. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry. Struct Heart. 2023 Nov 11;8(1):100226. doi: 10.1016/j.shj.2023.100226. eCollection 2024 Jan.
PubMed 38283573
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
- ClinicalTrials.gov ID
- NCT03752866
- Acronym / sponsor ID
- SJM-CIP-CL1003491
- Keywords
- Portico™ valve, Portico™ valve delivery system, Portico™ valve loading system, Transcatheter Aortic Valve Replacement, Aortic Stenosis, Heart Valve Prosthesis, TAVR, TAVR Registry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
Detailed description
The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.
Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.
The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.
| Arm | Type | Receives |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Experimental | Device: Portico™ Valve, Portico Delivery System(s) and Loading System(s)Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system will be included. |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Experimental | Device: Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems will be included. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
- Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
Key exclusion criteria (8 listed)
- Have sepsis, including active endocarditis
- Have any evidence of left ventricular or atrial thrombus
- Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
- Have a non-calcified aortic annulus
- Have congenital bicuspid or unicuspid leaflet configuration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portico™ Valve, Portico Delivery System(s) and Loading System(s)Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system. | Device | Portico™ Valve, Delivery System(s) and Loading System(s) |
| Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems. | Device | Portico™ Valve, FlexNav Delivery and Loading System(s) |
Primary outcome
Cardiovascular Mortality
Time frame: 30 days from the index procedure
Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
20 secondary outcomes
Number of Subjects With Myocardial Infarction
Time frame: At 30 days
Number of Subjects With Stroke
Time frame: At 30 days
Number of Subjects With Bleeding Events
Time frame: At 30 days
Number of Subjects With Acute Kidney Injury
Time frame: At 30 days
Number of Subjects With Vascular Complications
Time frame: At 30 days
Number of Subjects With Annular Rupture
Time frame: At 30 days
Number of Subjects With Coronary Obstruction
Time frame: At 30 days
Number of Subjects Undergoing Conversion To Open Surgery
Time frame: At 30 days
Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment
Time frame: At 30 days
Number Of Subjects With Valve Embolization
Time frame: At 30 days
Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion
Time frame: At 30 days
Vessel Diameter
Time frame: At 30 days
Introducer Sheath Used
Time frame: At 30 days
Implant Success
Time frame: At 30 days
Effective Orifice Area
Time frame: At 30 days
Aortic Valve Mean Gradient
Time frame: At 30 days
Number of Subjects With Paravalvular Leak (PVL)
Time frame: At 30 days
NYHA Classification
Time frame: At 30 days
EQ5D-3L Visual Analog Scale Value
Time frame: At 30 days
Kaplan-Meier Rate of All-cause Mortality
Time frame: At 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38283573Mollmann H, Linke A, Nombela-Franco L, Sluka M, Francisco Oteo Dominguez J, Montorfano M, Kim WK, Arnold M, Vasa-Nicotera M, Fichtlscherer S, Conradi L, Camuglia A, Bedogni F, Kohli K, Manoharan G. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry. Struct Heart. 2023 Nov 11;8(1):100226. doi: 10.1016/j.shj.2023.100226. eCollection 2024 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Möllmann principal investigator
St. Johannes Hospital, Dortmund, Germany
Vinny Podichetty study director
Abbott Structural Heart
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portico™ Valve, Portico Delivery System(s) and Loading System(s) and Portico™ Valve, FlexNav Delivery System(s) and Loading System(s) in people with Symptomatic Degenerative Aortic Stenosis and Severe Aortic Stenosis, run by Abbott Medical Devices at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Italy, Spain, United Kingdom, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Mortality (time frame: 30 days from the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.