Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy (CROSSVal)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Heart Disease
• Intervention / Treatment: Device: Percutaneous Balloon Mitral Valvulotomy

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Abeba
    • Addis Ababa, Addis Abeba, Ethiopia, 2500
      • Tikur Anbessa Specialized Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• significant mitral stenosis
• low Wilkins score (< 10)
• mitral regurgitation grade not more than 2

Exclusion Criteria:

• high Wilkins score (>10)
• unfavourable anatomy
• presence of left appendage thrombus
• non-conclusive periprocedural trans oesophageal echocardiography imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard Inoue balloon technique; 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.	Device: Percutaneous Balloon Mitral Valvulotomy; Stenotic mitral valve will be dilated to open the commissures
Active Comparator: wire assisted crossing; 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.	Device: Percutaneous Balloon Mitral Valvulotomy; Stenotic mitral valve will be dilated to open the commissures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in procedure duration	procedure time in minutes	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure failure	failed procedure after lengthy attempt	day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	short and long term survival	30 days
mortality	short and long term survival	3 months
Hospitalization for heart failure	hospitalization for worsening heart failure	2 year
Procedure related neurological events	new neurological events	day 1
Procedure related neurological events	new neurological events	30 days
Vascular complications requiring intervention	transfusion requiring bleeding or vascular complication requiring percutaneous or surgical intervention	day 1
new arrythmia	previously non existing arrythmia registered after intervention	day 1
new bradyarrythmia	new bradyarrythmia requiring device intervention	day 1

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Collaborators: Haukeland University Hospital
• Investigators: Principal Investigator: Nigussie Bogale, MD, PhD, Haukeland University Hospital, Bergen, Norway

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Fever; Heart Diseases; Rheumatic Heart Disease
• Other Study ID Numbers: 523036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: November 2023 through december 2026
• IPD Sharing Access Criteria: application must be submitted and signed electronically. The study team will asess the submitted proposals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes