NCT03567668

Surgical Valvuloplasty for Congenital Mitral Insufficiency

Status unknown Last updated 26 June 2018

What this trial tests

trial testing mitral valvuloplasty in Mitral Insufficiency in 200 participants. Status unknown.

Timeline

1 January 2012

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	Hong Liu
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 January 2012
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across China

Drugs / interventions tested

• mitral valvuloplasty

Conditions studied

• Mitral Insufficiency — all drugs for Mitral Insufficiency →
• Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →

Sponsor

Hong Liu — full company profile →

Who can join

Adults 3 Months to 18, any sex, with Mitral Insufficiency or Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly. Given that mitral replacement likely increased risk of cardiac dysfunction and mitral reoperation, mitral repair is the currently preferred surgical strategy in the majority of pediatric patients with mitral insufficiency. Unfortunately, previous evidences demonstrated the long-term hemodynamic alteration in response to significant mitral regurgitant might lead to a reversible or irreversible pulmonary vascular remodeling regardless of concomitant other cardiac malformations, which is associated with increased risk of morbidity and mortality following the surgery. Currently available researches mainly focused the association of pulmonary vascular pressures with risk of mortality and morbidity on adult rheumatic or degenerative mitral insufficiency; however, knowledge is still lacking regarding pediatric population with congenital mitral insufficiency. The investigator wil assess the relationship between baseline sPAP and risk of operative morbidity and mortality.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.