Rheumatic Heart DiseaseCROSSValNCT06150274
Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy
A study testing Percutaneous Balloon Mitral Valvulotomy in people with Rheumatic Heart Disease, run by Helse Stavanger HF at 1 site in Ethiopia.
Trial summary
The goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- Percutaneous Balloon Mitral Valvulotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEthiopia
- Study dates
- 24 May 2024to 3 Jun 2024
- 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
- significant mitral stenosis
- low Wilkins score (< 10)
- mitral regurgitation grade not more than 2
Who cannot join
- high Wilkins score (>10)
- unfavourable anatomy
- presence of left appendage thrombus
- non-conclusive periprocedural trans oesophageal echocardiography imaging
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Tikur Anbessa Specialized Hospital
Addis Ababa, Addis Ababa, 2500
About this study
Official title: Simplifying Percutaneous Balloon Mitral Valvulotomy (PBMV) to Reduce the Burden of Mitral Stenosis in Sub-Saharan Africa.
The goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Participants will be randomized to one of the two methods.
Read the detailed description
Background: Rheumatic valvular disease, a chronic sequela of acute rheumatic fever, is a leading cause of cardiovascular mortality in developing countries. The available options of management include surgical treatment and balloon valvulotomy. Among various forms of rheumatic valvular lesions, severe mitral stenosis with favorable morphology can be successfully treated by balloon valvulotomy.
Methods: The study is a randomized controlled trial with intervention in both arms.
The objective of this study is to compare procedural time as a primary end point.
- Conditions
- Rheumatic Heart Disease
- Being tested
- Percutaneous Balloon Mitral Valvulotomy
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Balloon Mitral ValvulotomyDevice
Stenotic mitral valve will be dilated to open the commissures
| Study group | Role | What they receive |
|---|---|---|
| standard Inoue balloon technique | Active comparator | Those randomized to the standard care will undergo the procedure using the contemporary Inoue balloon system (Toray Industries, Japan), which is available in 4 sizes: 24, 26, 28 and 30 mm. Receives: Device: Percutaneous Balloon Mitral Valvulotomy |
| wire assisted crossing | Active comparator | The procedure is performed on a similar fashion until atrial septal entry. Once the atrial wall is traversed, and the Mullins sheath is within the left atrium, the mitral valve is crossed with a flexible 0.032- or 0.035 in- 145 cm J-tipped wire. This step could be assisted by a steerable sheath. Once the mitral valve is crossed, the initial wire will be exchanged with a looped stiff wire (Safari or similar) to the left ventricle by use of a 5/6 f pigtail catheter. A commercially available balloon is used to perform the valvulotomy/commissurotomy procedure. Choice of balloon size is made following the formula: Balloon size = patient height (cm)/10 + 10. Fine tuning of the balloon size will be performed peri-operative based on transesophageal echo findings. Use of a separate stiff wire placed in the left atrium/pulmonary vein to ease passage through the atrial septum is left to the discretion of the operator based on the anatomical challenges faced during the procedure. Receives: Device: Percutaneous Balloon Mitral Valvulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in procedure duration
procedure time in minutes
Measured: day 1
Secondary outcomes (1)
procedure failure
failed procedure after lengthy attempt
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start24 May 2024
- Primary completion31 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Nigussie Bogale, MD, PhD, Principal investigator, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150274
- Sponsor's protocol ID
- 523036
- Acronym
- CROSSVal
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplifying Percutaneous Balloon Mitral Valvulotomy (PBMV) to Reduce the Burden of Mitral Stenosis in Sub-Saharan Africa.
- ClinicalTrials.gov ID
- NCT06150274
- Acronym / sponsor ID
- CROSSVal / 523036
- Conditions
- Rheumatic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Haukeland University Hospital
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 29 Nov 2023 (actual)
- 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 goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Participants will be randomized to one of the two methods.
Detailed description
Background: Rheumatic valvular disease, a chronic sequela of acute rheumatic fever, is a leading cause of cardiovascular mortality in developing countries. The available options of management include surgical treatment and balloon valvulotomy. Among various forms of rheumatic valvular lesions, severe mitral stenosis with favorable morphology can be successfully treated by balloon valvulotomy.
Methods: The study is a randomized controlled trial with intervention in both arms.
The objective of this study is to compare procedural time as a primary end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard Inoue balloon technique | Active comparator | Device: Percutaneous Balloon Mitral ValvulotomyThose randomized to the standard care will undergo the procedure using the contemporary Inoue balloon system (Toray Industries, Japan), which is available in 4 sizes: 24, 26, 28 and 30 mm. |
| wire assisted crossing | Active comparator | Device: Percutaneous Balloon Mitral ValvulotomyThe procedure is performed on a similar fashion until atrial septal entry. Once the atrial wall is traversed, and the Mullins sheath is within the left atrium, the mitral valve is crossed with a flexible 0.032- or 0.035 in- 145 cm J-tipped wire. This step could be assisted by a steerable sheath. Once the mitral valve is crossed, the initial wire will be exchanged with a looped stiff wire (Safari or similar) to the left ventricle by use of a 5/6 f pigtail catheter. A commercially available balloon is used to perform the valvulotomy/commissurotomy procedure. Choice of balloon size is made following the formula: Balloon size = patient height (cm)/10 + 10. Fine tuning of the balloon size will be performed peri-operative based on transesophageal echo findings. Use of a separate stiff wire placed in the left atrium/pulmonary vein to ease passage through the atrial septum is left to the discretion of the operator based on the anatomical challenges faced during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- significant mitral stenosis
- low Wilkins score (< 10)
- mitral regurgitation grade not more than 2
Key exclusion criteria (4 listed)
- high Wilkins score (>10)
- unfavourable anatomy
- presence of left appendage thrombus
- non-conclusive periprocedural trans oesophageal echocardiography imaging
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 |
|---|---|---|
| Percutaneous Balloon Mitral ValvulotomyStenotic mitral valve will be dilated to open the commissures | Device | standard Inoue balloon technique, wire assisted crossing |
Primary outcome
Reduction in procedure duration
Time frame: day 1
procedure time in minutes
1 secondary outcome
procedure failure
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Nigussie Bogale, MD, PhD principal investigator
Haukeland University Hospital, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Balloon Mitral Valvulotomy in people with Rheumatic Heart Disease, run by Helse Stavanger HF at 1 site in Ethiopia.
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 3 inclusion and 4 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 20 Jun 2024. 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 Ethiopia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in procedure duration (time frame: 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 20 Jun 2024.