Cardiac Function After Transcatheter VSD Closure

NCT03127748 | Unknown

• 1 other identifier: 201503039RINB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

With advances in interventional cardiac catheterization, ventricular septal defect (VSD) could be successfully treated via transcatheter device closure. Cardiac catheterization team of National Taiwan University Children's Hospital has recently treated more than 60 patients with VSD using this technique. Both treatment effect and follow-up results were encouraging. Of particular notice is that many patients experienced subjective improvement in exercise tolerance after VSD closure. Traditionally, VSD could only be repaired by open-heart surgery under cardiopulmonary bypass. Therefore, VSD closure would be considered only for those with moderate to large defect, significant heart failure, or presenting with significant exercise intolerance. With the success in transcatheter closure of VSD, a procedure which is safer and leading to faster recovery comparing to cardiac surgery, device closure of VSD would be a reasonable and sensible treatment of choice if it is beneficial for long-term cardiac function and exercise performance. This project will prospectively enroll 50 patients with VSDs subject to transcatheter closure of the defect in our institute. Before device closure and 6 months after closure, participants will be assessed with image studies (including speckle tracking and tissue Doppler echocardiography), measurements of serum biomarkers (including B-type natriuretic peptide and biomarkers of collagen metabolism), and standard cardiopulmonary exercise test. The purpose of this study is to investigate the potential benefits of closing VSD with respect to cardiac function and exercise performance, which might serve as basis to redefine future indication of VSD closure.

Conditions

Ventricular Septal Defect

Keywords

ventricular septal defect,transcatheter closure

Outcome Measures

Primary Outcomes (4)

• Changes in exercise capacity--peak oxygen consumption

  Changes in peak VO2 (% of predicted value)

  6 months

• Changes in exercise capacity--heart rate reserve

  Changes in heart rate reserve (beats per minute)

  6 months

• Changes in echocardiographic parameters-tissue Doppler imaging

  Tissue Doppler derived mitral systolic and diastolic velocities (cm/s)

  6 months

• Changes in echocardiographic parameters-strain and strain rate

  2D speckle tracking derived left ventricular longitudinal and circumferential strain (%) and strain rate (1/s)

  6 months

Secondary Outcomes (5)

• Changes in serum BNP level

  6 months

• Changes in circulating fibrosis markers

  6 months

• Changes in circulating fibrosis markers

  6 months

• Changes in circulating fibrosis markers

  6 months

• Changes in circulating fibrosis markers

  6 months

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with VSD attempting for transcatheter closure

You may qualify if:

• subject to transcatheter device closure of VSD (mostly using Amplatzer ductal occluder I and II for perimembranous VSD, and Amplatzer muscular VSD occluder for muscular VSD) based on clinical need;
• age between 12-60 years

You may not qualify if:

• additional hemodynamically significant structural anomalies, including more than mild degree of VSD-related aortic regurgitation or right ventricular outflow tract obstruction;
• pulmonary hypertension documented during cardiac catheterization;
• musculoskeletal anomalies limiting the performance of exercise testing;
• taking cardiac medications within 6 months of enrollment;
• having alcohol abuse, coronary artery disease, systemic hypertension, diabetes mellitus, liver disease, renal insufficiency, metabolic bone disease, autoimmune disease, and received operation or having a history of trauma within 6 months of study enrollment.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• E-DA Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Chen CA, Wang JK, Lin MT, Chiu HH, Hsu JY, Lin SM, Chang YM, Chiu SN, Lu CW, Wu MH, Yang MC. Exercise Capacity and Ventricular Remodeling After Transcatheter Ventricular Septal Defect Closure in Asymptomatic or Minimally Symptomatic Adolescents and Adults. Circ Cardiovasc Interv. 2020 Jun;13(6):e008813. doi: 10.1161/CIRCINTERVENTIONS.119.008813. Epub 2020 Jun 10.

  PMID: 32519889 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chun-An Chen, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-An Chen, MD, PhD

CONTACT

886-972651840; chenca@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2015
• First Posted: April 25, 2017
• Study Start: July 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

TW (1)