NCT01170624

Brief Summary

The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
388

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Sep 2009

Geographic Reach
5 countries

25 active sites

Status
terminated

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

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

June 16, 2010

Last Update Submit

January 9, 2015

Conditions

Heart Failure

Keywords

PhDEGMCRT-DThe study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)

Outcome Measures

Primary Outcomes (1)

  • The objective is to demonstrate that agreement correlation is superior to 67%

    13 months

Interventions

ICDDEVICE

Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines.
  • Documented chronic HF (NYHA Class II to IV) at the time of enrollment
  • Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
  • Signed and dated informed consent

You may not qualify if:

  • Any contraindication for ICD therapy
  • Abdominal implantation site
  • Acute myocarditis
  • Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
  • Planned heart transplant
  • Mechanical tricuspid valve
  • Unable to perform the 6 minute Walking Test at time of enrollment
  • Already included in another clinical study
  • Life expectancy less than 13 months
  • Inability to understand the purpose of the study or refusal to cooperate
  • Inability or refusal to provide informed consent
  • Under guardianship
  • Age of less than 18 years
  • Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen

Antwerp, 2020, Belgium

Location

Centre Hospitalier Général

Albi, 81013, France

Location

Centre Hospitalier Universitaire D'Amiens

Amiens, 80090, France

Location

Chu Annecy

Annecy, 74011, France

Location

CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON

Avignon, 84000, France

Location

Hopital D'Instruction Des Armees

Clamart, 92141, France

Location

Hôpital St Joseph

Lyon, 69000, France

Location

Centre Hospitalier Universitaire de La Timone

Marseille, 13000, France

Location

Hopital Le Raincy Montfermeil

Montfermeil, 93370, France

Location

HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie

Montpellier, 34295, France

Location

Hopital de La Source

Orléans, 45067, France

Location

Centre Hospitalier

Pau, 64000, France

Location

CLINIQUE ST PIERRE Cardiologie

Perpignan, 66000, France

Location

Ccn: Centre Cardiologique Du Nord St Denis

Saint-Denis, 93000, France

Location

Chru Hôpital Trousseau

Tours, 37000, France

Location

Kerckhoff Klinik Cardiology Department

Bad Nauheim, 61231, Germany

Location

Lerckhoff Klinik

Bad Neuheim, 61231, Germany

Location

Praxis Westend Studien GbR, Medianzentrum Haus 9

Berlin, 14050, Germany

Location

Klinik Frankische Schweiz

Ebermannstadt, 91316 - 91320, Germany

Location

Med. Univ. Klinik Lübeck

Lübeck, 23501 - 23570, Germany

Location

Spedali Civili Divisione di Cardiologia

Brescia, 25123, Italy

Location

Azienda Ospedaliera S. Croce E Carle

Cuneo, 12100, Italy

Location

Hospital de Santa Cruz - Carnaxide (Adragão)

Carnaxide, Lisbon District, 2795, Portugal

Location

Hospital Garcia de Orta

Almada, 2801-951, Portugal

Location

Hospital Central Faro

Faro, 8000, Portugal

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 16, 2010

First Posted

July 27, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 12, 2015

Record last verified: 2015-01

Locations

DE(5)BE(1)IT(2)FR(14)PT(3)