Clinical trial NCT01992458: Primary Prevention ICD French Registry
Official title: Observatoire Multicentrique Français Des Porteurs de Défibrillateur Automatique Implantable en Prévention Primaire (Cardiopathie Ischémique ou Cardiomyopathie Dilatée)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluation of Primary Prevention ICD in Real Life
Keywords: implantable cardioverter defibrillator
death
shock
mortality
complication
sudden death
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
Collaborators: name: Clinique Pasteur Toulouse
name: European Georges Pompidou Hospital
name: University Hospital, Grenoble
name: University Hospital, Bordeaux
name: University Hospital, Lille
name: University Hospital, Marseille
name: Centre Cardiologique du Nord, St Denis
name: Nouvelles Cliniques Nantaises, Nantes
name: Hopital Antoine Beclere, Clamart
name: Rennes University Hospital
name: Central Hospital, Nancy, France
name: University Hospital, Tours
First posted: 2013-11-25
Enrollment: 5576
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from 12 medical centers implanted with an implantable cardioverter defibrillator (ICD) in the setting of primary prevention since Jan. 1, 1997, in France

Brief summary: The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death has been introduced later in France than in other parts of the World. Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease or dilated cardiomyopathy with low ejection fraction implanted with an ICD in the setting of primary prevention (criteria at the discretion of the physician)

Exclusion Criteria:

* Setting of secondary prevention
* Other cardiopathies such as congenital, channelopathies, valvulopathies

Primary outcomes:
measure: Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications
timeFrame: 3-year
Secondary outcomes:
measure: Cause-of-Death Analysis
timeFrame: 3-year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Clinique Pasteur
name: Serge Boveda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital européen Georges Pompidou
name: Eloi Marijon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Escande W, Boveda S, Defaye P, Leclercq C, Sadoul N, Perier MC, Deharo JC, Fauchier L, Marijon E, Piot O; DAI-PP Investigators. Outcomes in Guideline-Based Versus Off-Guideline Primary Prevention Implantable Cardioverter-Defibrillator Recipients. J Am Coll Cardiol. 2017 Sep 5;70(10):1302-1303. doi: 10.1016/j.jacc.2017.07.711. No abstract available.
citation: Amara N, Boveda S, Defaye P, Klug D, Treguer F, Amet D, Perier MC, Gras D, Algalarrondo V, Bouzeman A, Piot O, Deharo JC, Fauchier L, Babuty D, Bordachar P, Sadoul N, Marijon E, Leclercq C; DAI-PP Investigators. Implantable cardioverter-defibrillator therapy among patients with non-ischaemic vs. ischaemic cardiomyopathy for primary prevention of sudden cardiac death. Europace. 2018 Jan 1;20(1):65-72. doi: 10.1093/europace/euw379.
citation: Clementy N, Challal F, Marijon E, Boveda S, Defaye P, Leclercq C, Deharo JC, Sadoul N, Klug D, Piot O, Gras D, Bordachar P, Algalarrondo V, Fauchier L, Babuty D; DAI-PP Investigators. Very high rate programming in primary prevention patients with reduced ejection fraction implanted with a defibrillator: Results from a large multicenter controlled study. Heart Rhythm. 2017 Feb;14(2):211-217. doi: 10.1016/j.hrthm.2016.10.024. Epub 2016 Oct 28.
citation: Escande W, Marijon E, Defaye P, Piot O, Leclercq C, Sadoul N, Deharo JC, Empana JP, Boveda S, Klug D. Electrical Storms in Patients With Implantable Cardioverter-Defibrillators for Primary Prevention. J Am Coll Cardiol. 2016 Sep 13;68(11):1248-1250. doi: 10.1016/j.jacc.2016.06.039. No abstract available.
citation: Providencia R, Marijon E, Lambiase PD, Bouzeman A, Defaye P, Klug D, Amet D, Perier MC, Gras D, Algalarrondo V, Deharo JC, Leclercq C, Fauchier L, Babuty D, Bordachar P, Sadoul N, Piot O, Boveda S. Primary Prevention Implantable Cardioverter Defibrillator (ICD) Therapy in Women-Data From a Multicenter French Registry. J Am Heart Assoc. 2016 Feb 12;5(2):e002756. doi: 10.1161/JAHA.115.002756.