Heart Valve DiseasesNCT01821651
Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room
A study testing HeartNavigator and EchoNav in people with Heart Valve Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
Objectives: Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- HeartNavigator and EchoNav
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients over 18 years of age.
- Ability and willingness to give informed consent.
- Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.
- Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).
Who cannot join
- Contraindications on ethical grounds,
- Women who are pregnant or breast feeding,
- Emergency cases,
- Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,
- Known renal insufficiency (GFR < 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),
- Contraindications for transesophageal Echo (EchoNav patients only, TAVI is possible without TEE and TEE is not needed for the HeartNavigator),
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- Known or suspected drug or alcohol abuse,
- Enrollment into a clinical trial within last 4 weeks if overlapping enrolment is not explicitly approved by ethics committee for the two trials,
- Patient is unable or unwilling to cooperate with the study protocol.
Trial locations and contacts
1 site in 1 country.
Simon Sündermann, MD contact
Volkmar Falk, Prof MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Division of Cardiovascular Surgery
Zurich, Canton of Zurich, 8091
About this study
Official title: Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
Objectives:
Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.
Read more
Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).
This pilot study aims at observing these aims on a small patient population and a control group.
Number of Subjects:
140 patients total in 6 groups:
- MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
- MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
- TAVI with HeartNavigator lead in (10)
- TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).
Read the detailed description
Medical Device:
HeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.
EchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.
- Conditions
- Heart Valve Diseases
- Being tested
- HeartNavigator, EchoNav, Control-Group EN, Control-group HN
- Keywords
- TAVI, MitraClip, image modality, echocardiography, angiography
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartNavigatorDevice
Also called HeartNavigator, procedure with software
Procedure with software
EchoNavDevice
Also called EchoNav, procedure with software
Procedure with software
Control-Group ENOther
Also called Compare to EchoNav-group
Procedure without software
Control-group HNOther
Also called Compare to HeartNavigator-group
Procedure without software
| Study group | Role | What they receive |
|---|---|---|
| HeartNavigator | Experimental | Group with HeartNavigator-Software Receives: Device: HeartNavigator |
| Control | Active comparator | Control-group without HeartNavigator-Software Receives: Other: Control-group HN |
| EchoNav | Experimental | Group with EchoNav-Software Receives: Device: EchoNav |
| Conrol | Active comparator | Control-group without EchoNav-Software Receives: Other: Control-Group EN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dose (mSv) administered to each patient
At the end of the procedure the recorded radiation-dose is assessed.
Measured: Day of intervention (day 1)
Secondary outcomes (5)
Duration of the intervention (minutes)
At the end of the procedure the skin-to-skin-time is assessed.
Measured: Day of intervention (day 1)
Contrast agent dose (ml)
At the end of the procedure the recorded contrast agent dose is assessed.
Measured: Day of intervention (day 1)
Increased quality of care (EchoNav group)
Usually 1 to 5 days after intervention
Measured: Discharge: 1 to 5 days after intervention
Degree of Mitral Regurgitation (EchoNav group)
Usually 1 to 5 days after intervention
Measured: Discharge: 1 to 5 days after intervention
Postinterventional transvalvular gradient
Catheter-based direct measurement
Measured: Up to 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Volkmar Falk, Prof MD, Principal investigator, University Hospital Zurich, Division of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821651
- Sponsor's protocol ID
- HOR-1
- Status last verified
- Jun 2013
- First submitted
- 10 Dec 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
- ClinicalTrials.gov ID
- NCT01821651
- Acronym / sponsor ID
- HOR-1
- Conditions
- Heart Valve Diseases
- Keywords
- TAVI, MitraClip, image modality, echocardiography, angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 1 Apr 2013 (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.
Objectives:
Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.
Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).
This pilot study aims at observing these aims on a small patient population and a control group.
Number of Subjects:
140 patients total in 6 groups:
- MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
- MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
- TAVI with HeartNavigator lead in (10)
- TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).
Detailed description
Medical Device:
HeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.
EchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HeartNavigator | Experimental | Device: HeartNavigatorGroup with HeartNavigator-Software |
| Control | Active comparator | Other: Control-group HNControl-group without HeartNavigator-Software |
| EchoNav | Experimental | Device: EchoNavGroup with EchoNav-Software |
| Conrol | Active comparator | Other: Control-Group ENControl-group without EchoNav-Software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients over 18 years of age.
- Ability and willingness to give informed consent.
- Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.
- Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).
Key exclusion criteria (9 listed)
- Contraindications on ethical grounds,
- Women who are pregnant or breast feeding,
- Emergency cases,
- Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,
- Known renal insufficiency (GFR < 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),
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 |
|---|---|---|
| HeartNavigatorAlso: HeartNavigator, procedure with softwareProcedure with software | Device | HeartNavigator |
| EchoNavAlso: EchoNav, procedure with softwareProcedure with software | Device | EchoNav |
| Control-Group ENAlso: Compare to EchoNav-groupProcedure without software | Other | Conrol |
| Control-group HNAlso: Compare to HeartNavigator-groupProcedure without software | Other | Control |
Primary outcome
Radiation Dose (mSv) administered to each patient
Time frame: Day of intervention (day 1)
At the end of the procedure the recorded radiation-dose is assessed.
5 secondary outcomes
Duration of the intervention (minutes)
Time frame: Day of intervention (day 1)
Contrast agent dose (ml)
Time frame: Day of intervention (day 1)
Increased quality of care (EchoNav group)
Time frame: Discharge: 1 to 5 days after intervention
Degree of Mitral Regurgitation (EchoNav group)
Time frame: Discharge: 1 to 5 days after intervention
Postinterventional transvalvular gradient
Time frame: Up to 7 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
Simon Sündermann, MD contact
Volkmar Falk, Prof MD contact
Volkmar Falk, Prof MD principal investigator
University Hospital Zurich, Division of Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartNavigator and EchoNav in people with Heart Valve Diseases, run by University of Zurich at 1 site in Switzerland.
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: status not confirmed, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Sündermann, MD (simon.suendermann@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dose (mSv) administered to each patient (time frame: Day of intervention (day 1)). 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 19 Jun 2013.