Skip to main content
OpenTrials
Completed

NCT Number: NCT06150274

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tikur Anbessa Specialized Hospital

Addis Ababa, 2500, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Balloon Mitral Valvulotomy

Device

Stenotic mitral valve will be dilated to open the commissures

Primary outcomes

  1. Reduction in procedure duration

    Time frame: day 1

    procedure time in minutes

Secondary outcomes

  1. procedure failure

    Time frame: day 1

    failed procedure after lengthy attempt

Other outcomes

  1. mortality

    Time frame: 30 days

    short and long term survival

  2. mortality

    Time frame: 3 months

    short and long term survival

  3. Hospitalization for heart failure

    Time frame: 2 year

    hospitalization for worsening heart failure

  4. Procedure related neurological events

    Time frame: day 1

    new neurological events

  5. Procedure related neurological events

    Time frame: 30 days

    new neurological events

  6. Vascular complications requiring intervention

    Time frame: day 1

    transfusion requiring bleeding or vascular complication requiring percutaneous or surgical intervention

  7. new arrythmia

    Time frame: day 1

    previously non existing arrythmia registered after intervention

  8. new bradyarrythmia

    Time frame: day 1

    new bradyarrythmia requiring device intervention

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

Simplifying Percutaneous Balloon Mitral Valvulotomy (PBMV) to Reduce the Burden of Mitral Stenosis in Sub-Saharan Africa.

Acronym: CROSSVal

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2023
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.