NCT01992458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

November 12, 2013

Last Update Submit

November 19, 2013

Conditions

Evaluation of Primary Prevention ICD in Real Life

Keywords

implantable cardioverter defibrillatordeathshockmortalitycomplicationsudden death

Outcome Measures

Primary Outcomes (1)

  • Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications

    3-year

Secondary Outcomes (1)

  • Cause-of-Death Analysis

    3-year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Pasteur

Toulouse, France

Location

Related Publications (5)

  • 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.

    PMID: 28859794DERIVED

  • 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.

    PMID: 28082419DERIVED

  • 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.

    PMID: 27989789DERIVED

  • 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.

    PMID: 27609689DERIVED

  • 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.

    PMID: 26873687DERIVED

MeSH Terms

Conditions

DeathShockDeath, Sudden

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Serge Boveda, MD

    Clinique Pasteur

    PRINCIPAL INVESTIGATOR

  • Eloi Marijon, MD

    Hopital européen Georges Pompidou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 25, 2013

Study Start

January 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

FR(1)