Mitral InsufficiencyNCT02515539
Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)
A study testing CardiAQ TMVI System (Transapical & Transfemoral DS) in people with Mitral Insufficiency and Heart Valve Disease, run by Edwards Lifesciences.
Trial summary
The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease
- What is being tested?
- CardiAQ TMVI System (Transapical & Transfemoral DS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA Classification ≥ III
- Left Ventricular Ejection Fraction ≥ 30%
- Mitral Regurgitation ≥ Grade 3+
- Subject meets anatomical and eligibility criteria for the investigational device
Who cannot join
- See Protocol
About this study
Official title: Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems)
The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System.
The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Read the detailed description
Early feasibility study - multi-center, prospective, single-arm, and non-randomized study without concurrent or historical controls.
The primary objective of the study is to generate early feasibility data for the CardiAQ™ Transcatheter Mitral Valve Implant System with the Transfemoral and Transapical Delivery Systems for the treatment of moderate to severe mitral valve regurgitation in patients who are considered high risk for mortality and morbidity from conventional open-heart surgery.
The secondary objectives of the study are to evaluate the long-term safety of the device and the effects of the device on performance, functional, quality of life parameters, and technical, device, procedural, and individual patient successes.
The study is to be performed at a maximum of 5 investigational sites in the US.
- Being tested
- CardiAQ TMVI System (Transapical & Transfemoral DS)
- Keywords
- Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical, Transfemoral
- Medical subject headings
- Mitral Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiAQ TMVI System (Transapical & Transfemoral DS)Device
CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System
| Study group | Role | What they receive |
|---|---|---|
| CardiAQ TMVI System (Transapical & Transfemoral DS) | Experimental | CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System Receives: Device: CardiAQ TMVI System (Transapical & Transfemoral DS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Major Adverse Event Rate
Measured: 30-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Edwards Lifesciences terminated the IDE associated with this study. No patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilson Szeto, MD, Principal investigator, University of PennsylvaniaHoward Herrmann, MD, Principal investigator, University of PennsylvaniaSaibal Kar, MD, Principal investigator, Cedars-Sinai Medical CenterAlfredo Trento, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515539
- Sponsor's protocol ID
- CIP-3103-01
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems)
- ClinicalTrials.gov ID
- NCT02515539
- Acronym / sponsor ID
- CIP-3103-01
- Keywords
- Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical, Transfemoral
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Edwards Lifesciences terminated the IDE associated with this study. No patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
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 the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System.
The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Detailed description
Early feasibility study - multi-center, prospective, single-arm, and non-randomized study without concurrent or historical controls.
The primary objective of the study is to generate early feasibility data for the CardiAQ™ Transcatheter Mitral Valve Implant System with the Transfemoral and Transapical Delivery Systems for the treatment of moderate to severe mitral valve regurgitation in patients who are considered high risk for mortality and morbidity from conventional open-heart surgery.
The secondary objectives of the study are to evaluate the long-term safety of the device and the effects of the device on performance, functional, quality of life parameters, and technical, device, procedural, and individual patient successes.
The study is to be performed at a maximum of 5 investigational sites in the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardiAQ TMVI System (Transapical & Transfemoral DS) | Experimental | Device: CardiAQ TMVI System (Transapical & Transfemoral DS)CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NYHA Classification ≥ III
- Left Ventricular Ejection Fraction ≥ 30%
- Mitral Regurgitation ≥ Grade 3+
- Subject meets anatomical and eligibility criteria for the investigational device
Key exclusion criteria (1 listed)
- See Protocol
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 |
|---|---|---|
| CardiAQ TMVI System (Transapical & Transfemoral DS)CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System | Device | CardiAQ TMVI System (Transapical & Transfemoral DS) |
Primary outcome
Composite Major Adverse Event Rate
Time frame: 30-Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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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.
Wilson Szeto, MD principal investigator
University of Pennsylvania
Howard Herrmann, MD principal investigator
University of Pennsylvania
Saibal Kar, MD principal investigator
Cedars-Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing CardiAQ TMVI System (Transapical & Transfemoral DS) in people with Mitral Insufficiency and Heart Valve Disease, run by Edwards Lifesciences.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite Major Adverse Event Rate (time frame: 30-Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2016.