Transapical Transcatheter Aortic Valve ImplantationNCT01722591
Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System
A study testing Cardiapex device in people with Transapical Transcatheter Aortic Valve Implantation, run by Cardiapex Ltd. at 2 sites in Germany.
Trial summary
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Transapical Transcatheter Aortic Valve Implantation
- What is being tested?
- Cardiapex device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2013to Feb 2014
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient scheduled for transapical TAVI
- Patient ≥ 70 years of age
- Patient able to give informed written consent
- Patient able to attend follow up examinations
Who cannot join
- Scheduled concomitant non-TAVI cardiac procedure
- Patient with Left Ventricular Ejection Fraction (LVEF) < 30% at time of enrollment
- Patient with known apical infarcted area
- Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
- Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
- Patient with contra-indications to transapical TAVI
Show all 9Show fewer
- Patient's inability to tolerate or comply with normal post-surgical drug regimen
- Patient's inability to comply with required follow-ups, including echocardiography
- Patient participation in other clinical trials within previous month
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Kerckhoff Clinic
Bad Nauheim
Hamburg University Heart Center
Hamburg
About this study
Official title: A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).
- Being tested
- Cardiapex device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiapex deviceDevice
Cardiapex percutaneous transapical access and closure system
| Study group | Role | What they receive |
|---|---|---|
| Cardiapex device | Experimental | Use of the Cardiapex device in the context of transapical TAVI procedures Receives: Device: Cardiapex device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"
Measured: Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours
Secondary outcomes (1)
≤30 day apical bleeding requiring surgical intervention
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transapical Transcatheter Aortic Valve ImplantationStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiapex Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722591
- Sponsor's protocol ID
- CLN-PRO-01
- Status last verified
- Feb 2015
- First submitted
- 2 Nov 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System
- ClinicalTrials.gov ID
- NCT01722591
- Acronym / sponsor ID
- CLN-PRO-01
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cardiapex Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 7 Nov 2012 (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.
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiapex device | Experimental | Device: Cardiapex deviceUse of the Cardiapex device in the context of transapical TAVI procedures |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient scheduled for transapical TAVI
- Patient ≥ 70 years of age
- Patient able to give informed written consent
- Patient able to attend follow up examinations
Key exclusion criteria (9 listed)
- Scheduled concomitant non-TAVI cardiac procedure
- Patient with Left Ventricular Ejection Fraction (LVEF) < 30% at time of enrollment
- Patient with known apical infarcted area
- Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
- Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
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 |
|---|---|---|
| Cardiapex deviceCardiapex percutaneous transapical access and closure system | Device | Cardiapex device |
Primary outcome
Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"
Time frame: Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours
1 secondary outcome
≤30 day apical bleeding requiring surgical intervention
Time frame: 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiapex device in people with Transapical Transcatheter Aortic Valve Implantation, run by Cardiapex Ltd. at 2 sites in Germany.
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 9 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: stopped early, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study was stopped early. Results are not available in the source record.
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?
Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve" (time frame: Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours). 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 4 Feb 2015.