Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement

NCT03793296 | Withdrawn

• 1 other identifier: AMCCV2018-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.

Conditions

Cardiac Valves; Heart Valve Diseases; Valvular Insufficiency

Keywords

Paravalvular leak

Outcome Measures

Primary Outcomes (1)

• Degree of para-valvular leakage

  classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)

  1 month

Secondary Outcomes (10)

• Event rate of all cause death

  up to 5 years

• Event rate of cardiac death

  up to 5 years

• Event rate of stroke

  up to 5 years

• Event rate of myocardial infarction

  up to 5 years

• Event rate of rehospitalization

  up to 5 years

Study Arms (1)

Paravalvular leak

EXPERIMENTAL

After transcatheter- or surgical valve replacement

Device: Percutaneous Device Closure: Vascular plug

Interventions

Percutaneous Device Closure: Vascular plug DEVICE

percutaneous transcatheter approach into cardiac valve

Paravalvular leak

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
• Required treatment of paravalvular leakage due to heart failure or hemolysis
• There is a formal agreement of heart team as following
• predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative mortality is ≥15%)
• Inoperable status due to old age or frailty
• Written consent

You may not qualify if:

• Risk of valve embolization because of valve dehiscence or instability
• Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
• Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
• Life expectancy less than 6 months due to non-cardiac disease
• Pregnant or breastfeeding

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 4, 2019
• Study Start: January 31, 2019
• Primary Completion: June 30, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

KR (1)