Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy

NCT06150274 | Completed DMC FDA Device

• 1 other identifier: 523036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. Participants will be randomized to one of the two methods.

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Reduction in procedure duration

  procedure time in minutes

  day 1

Secondary Outcomes (1)

• procedure failure

  day 1

Other Outcomes (8)

• mortality

  30 days

• mortality

  3 months

• Hospitalization for heart failure

  2 year

Study Arms (2)

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.

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.

Device: Percutaneous Balloon Mitral Valvulotomy

Interventions

Percutaneous Balloon Mitral Valvulotomy DEVICE

Stenotic mitral valve will be dilated to open the commissures

standard Inoue balloon technique; wire assisted crossing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Tikur Anbessa Specialized Hospital

Addis Ababa, Addis Abeba, 2500, Ethiopia

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nigussie Bogale, MD, PhD

  Haukeland University Hospital, Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 29, 2023
• Study Start: May 24, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 3, 2024
• Last Updated: June 20, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: November 2023 through december 2026
• Access Criteria: application must be submitted and signed electronically. The study team will asess the submitted proposals.

Locations

ET (1)