Clinical Trials Logo
  1. Home
  2. Ventricular Dysfunction, Left
  3. NCT03701997

Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

Ventricular Dysfunction Clinical Trial

Official title:
All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

Clinical Trial Summary

The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.

Clinical Trial Description

The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03701997
Study type Observational [Patient Registry]
Source Berlin Heart, Inc
Contact
Status Enrolling by invitation
Phase
Start date October 15, 2018
Completion date May 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03799133 - Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery N/A
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Completed NCT01673230 - Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%) N/A
Completed NCT00982397 - Safety and Clinical Performance of the Protecta ICD and CRT-D N/A
Completed NCT00187252 - Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy N/A
Recruiting NCT04848844 - The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)
Recruiting NCT05851053 - Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
Recruiting NCT02644850 - Comparison of Gated Blood-pool SPECT and Echocardiogram for Ventricular Function N/A
Terminated NCT00524862 - Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death N/A
Completed NCT00526162 - ConsultaTM CRT-D Clinical Evaluation Study N/A
Withdrawn NCT00166010 - Effects of Nesiritide in Pediatric Patients With Heart Failure N/A
Completed NCT00370643 - Glucose Control in Open Heart Surgery Phase 1
Not yet recruiting NCT04068116 - Impact of Ischemic Post-conditioning N/A
Completed NCT02497950 - HeartMate 3 ELEVATE™ Registry
Recruiting NCT05934071 - Effects of the Sodium-glucose Cotransporter 2 Inhibitors+Sacubitril/Valsartan Therapy in Patients With HFrEF.
Recruiting NCT02816047 - Austrian Wearable Cardioverter Defibrillator Registry
Completed NCT04634708 - The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
Terminated NCT02820441 - Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance Phase 4
Completed NCT00893360 - CArdiosphere-Derived aUtologous Stem CElls to Reverse ventricUlar dySfunction Phase 1
Completed NCT01452165 - Peripheral Artery Disease in Vastmanland