Cardiac Resynchronization Therapy in Congenital Heart Diseases With Systemic Right Ventricle

NCT04842851 | Completed FDA Device

• 1 other identifier: 2219047
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to analyze outcomes of patients with systemic right ventricle (SRV) implanted with Cardiac Resynchronization Therapy (CRT) systems and to compare the impact of CRT in SRV patients with other congenital heart diseases (CHD).

Conditions

Congenital Heart Disease

Keywords

cardiac resynchronization therapy; congenital heart disease; systemic right ventricle; outcomes

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with response to CRT

  Proportion of patients with improvement of NYHA classification by at least one grade or improvement of systemic ventricular ejection fraction by at least 10%

  6-month, 12-month, 24-month

• Proportion of patients with response to CRT

  Proportion of patients with improvement of NYHA classification by at least one grade or improvement of systemic ventricular ejection fraction by at least 10%

  12-month

• Proportion of patients with response to CRT

  Proportion of patients with improvement of NYHA classification by at least one grade or improvement of systemic ventricular ejection fraction by at least 10%

  24-month

Secondary Outcomes (3)

• Overall mortality

  5 and 10 years

• Overall mortality or heart transplantation

  5 and 10 years

• Complications associated with CRT

  Acute (<30 days after procedure) and late (>30 days)

Interventions

cardiac resynchronization therapy DEVICE

Cardiac resynchronization therapy in patients with systemic right ventricle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with congenital heart disease and CRT device. The group of patients with systemic right ventricle include patients with D-transposition of the great arteries (D-TGA) with atrial switch operation (Mustard or Senning surgery) and patients with congenitally-corrected transposition of the great arteries (cc-TGA) with SRV (excluding cc-TGA with systemic left ventricle post surgical repair, e.g., arterial switch procedure or Rastelli surgery).

You may qualify if:

• All patients with congenital heart disease and CRT device

You may not qualify if:

• Patient's refusal

Sponsors & Collaborators

• Paris Cardiovascular Research Center (Inserm U970): lead
• Marie Lannelongue Hospital, Le Plessis Robinson, France: collaborator
• Clinique Pasteur Toulouse: collaborator
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• Hopital Louis Pradel: collaborator
• University Hospital, Montpellier: collaborator
• European Georges Pompidou Hospital: collaborator

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Victor Waldmann, MD, PhD

  Georges Pompidou European Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 13, 2021
• Study Start: January 1, 2004
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04