Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000404921p
Ethics application status
Submitted, not yet approved
Date submitted
4/02/2020
Date registered
25/03/2020
Date last updated
25/03/2020
Date data sharing statement initially provided
25/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the NuVera ICE Catheter during Percutaneous Procedures in which access to the left atrium is performed via transseptal puncture
Scientific title
Evaluation of the NuVera ICE Catheter during Percutaneous Procedures in which access to the left atrium is performed via transseptal puncture
Secondary ID [1] 300429 0
none
Universal Trial Number (UTN)
U1111-1247-7049
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 316084 0
Condition category
Condition code
Cardiovascular 314364 314364 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
the imaging probe for echocardiographic imaging will be will be performed using a catheter probe with the ability to use echo to image cardiac structure like the right atrium to visualize the intra atrial septum where a catheter for ablation will be passed through a sheath to deliver therapy. This is performed by an electrophysiologist. The setting is in a catheterization lab. Imaging will occur only once in the first part of the procedure prior to therapy and typically is in the range of 10 minutes or less depending upon ability to visualize the septum.
Intervention code [1] 316726 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322729 0
Tracking and analyzing the type of adverse events reported and proportion of participants with and without adverse events related to the use of the investigational catheter insertion and imaging through procedure completion. Routine events experienced during catheterization include i.e. vessel damage, air embolism or allergic reactions will be assessed post procedurally and compared to standard of care intracardiac echo catheters. Safety outcomes will be assessed through 24 hours post procedure including bleeding or embolic events using data collection forms and anticipated adverse events as described in the instructions per use.
Timepoint [1] 322729 0
Events will be assessed through procedure completion and 24 hours post procedure.
Secondary outcome [1] 379481 0
Tracking and analyzing the type of adverse events experienced during catheterization will be assessed through 7 days post procedure and compared to adverse events in the literature using intracardiac echo catheters using standardized data collection forms.
Timepoint [1] 379481 0
Events will be tabulated through 7 days post procedure. Potential adverse events include those experienced in routine catheterization procedures where a catheter is inserted into a vessel. Examples would be vessel damage, hematoma, air embolism and allergic reactions.
Secondary outcome [2] 381473 0
User Questionnaires assessing 2D and 3D imaging quality and ability to visualize cardiac structures will be completed by users. Ratings are tabulated using a Likert Scale rating quality of visualization between 1-5. One (1) = not imaging at all to five (5) very good imaging.
Timepoint [2] 381473 0
Ratings will be tabulated post procedurally.

Eligibility
Key inclusion criteria
suitable candidates scheduled for elective procedure requiring transseptal access to the left heart
eighteen years to eighty years of age
signed inform consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
2. Severe cerebrovascular disease or history of cerebrovascular event within one (1) month
3. History of chronic GI medical problems involving the esophagus or stomach
4. Active gastrointestinal bleeding, infection or fever (temp> 100.5/38C)
5. Severe co morbidity or short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease
6. Structural heart disease of clinical significance including:
a. Stable/unstable angina or ongoing myocardial ischemia
b. Myocardial infarction (MI) within three months of enrollment
c. Aortic or mitral valve disease > Grade II
d. Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
7. Female patient is pregnant or lactating or planning to become pregnant during the study period.
8. History of uncontrolled blood clotting (bleeding or thrombotic) abnormalities
9. Known sensitivities to heparin

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2020
Actual
Date of last participant enrolment
Anticipated
25/08/2020
Actual
Date of last data collection
Anticipated
8/09/2020
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 22310 0
New Zealand
State/province [1] 22310 0
Christchurch

Funding & Sponsors
Funding source category [1] 304848 0
Commercial sector/Industry
Name [1] 304848 0
NuVera Medical Inc.
Country [1] 304848 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
NuVera Medical Inc.
Address
140 Knowles Drive Los Gatos, California 95032
Country
United States of America
Secondary sponsor category [1] 305186 0
None
Name [1] 305186 0
Address [1] 305186 0
Country [1] 305186 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305257 0
Canterbury District Health Board HDEC
Ethics committee address [1] 305257 0
32 Oxford Terrace
Christchurch 8011
Ethics committee country [1] 305257 0
New Zealand
Date submitted for ethics approval [1] 305257 0
25/02/2020
Approval date [1] 305257 0
Ethics approval number [1] 305257 0

Summary
Brief summary
The device studied in this trial is an intracardiac echocardiographic catheter intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology in the heart of adult and pediatric patients. It is for imaging guidance only.
The study is intended to evaluate images acquired by the catheter during percutaneous procedures in which access to the left atrium is performed via transseptal puncture.
Safety criteria based on ability to image adequately as evidenced by the absence of device or procedure related adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99794 0
Prof Ian Crozier
Address 99794 0
Christchurch Hospital, Riccarton Avenue, Christchurch 8011
Country 99794 0
New Zealand
Phone 99794 0
+64033641096
Fax 99794 0
+64 033786378
Email 99794 0
[email protected]
Contact person for public queries
Name 99795 0
Ms Laura Minarsch
Address 99795 0
NuVera Medical
140 Knowles Drive
Los Gatos, California 95032
Country 99795 0
United States of America
Phone 99795 0
+19492805700
Fax 99795 0
+19494940557
Email 99795 0
[email protected]
Contact person for scientific queries
Name 99796 0
Prof Ian Crozier
Address 99796 0
Christchurch Hospital, Riccarton Avenue, Christchurch 8011
Country 99796 0
New Zealand
Phone 99796 0
+64033641096
Fax 99796 0
+64 033786378
Email 99796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No trial data will be shared unless by the sponsor


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.