Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator (DAI-T4F)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03837574
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Marijon, Paris Sudden Death Expertise Center

Tracking Information
First Submitted Date January 27, 2019
First Posted Date February 12, 2019
Last Update Posted Date February 12, 2019
Actual Study Start Date December 1, 2010
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2019)
  • Ventricular arrhythmias [ Time Frame: through study completion, an average of 1 year ]
    Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation
  • Complications of ICD [ Time Frame: through study completion, an average of 1 year ]
    Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
Official Title French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
Brief Summary National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.
Detailed Description

Inclusion criteria:

  • patient with tetralogy of Fallot > 18 years
  • implantable cardioverter defibrillator (ICD)
  • primary or secondary prevention

All french centers performing ICD implantation are annually contacted to include all patients with tetralogy of Fallot and ICD.

Retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with prospective follow up and annual update.

All events are centrally adjudicated with collection of all baseline ECG and reviewing of endocavitary EGM.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 20 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All adult patients with tetralogy of Fallot and implantablle cardioverter defibrillator in France
Condition
  • Tetralogy of Fallot
  • Implantable Defibrillator User
  • Congenital Heart Disease
  • Sudden Cardiac Death
  • Ventricular Arrythmia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 9, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2030
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • tetralogy of Fallot
  • implantable cardioverter defibrillator

Exclusion Criteria:

  • age < 18 years
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Victor Waldmann, MD +33676098007 vicrtor.waldmann@inserm.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03837574
Other Study ID Numbers CNIL2029070
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marijon, Paris Sudden Death Expertise Center
Study Sponsor Paris Sudden Death Expertise Center
Collaborators Not Provided
Investigators
Principal Investigator: Victor Waldmann, MD Paris Sudden Death Expertise Center
PRS Account Paris Sudden Death Expertise Center
Verification Date February 2019