NCT00382525

Brief Summary

To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy), implantable loop recorders and leads used within their intended use. Clinical variables will be analyzed in relation to device-based data and diagnostics.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
8,586

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
6 countries

27 active sites

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, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 3, 2025

Status Verified

September 1, 2017

Enrollment Period

7.8 years

First QC Date

September 28, 2006

Last Update Submit

June 30, 2025

Conditions

ArrhythmiaSinus Node DiseaseHeart FailureHeart Block

Keywords

BradyarrhythmiaAtrial FibrillationVentricular TachycardiaVentricular FibrillationHeart FailurePacemakerImplantable Cardioverter DefibrillatorCardiac Resynchronization TherapyLoop recorderRegistry

Outcome Measures

Primary Outcomes (1)

  • To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices

    To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pulse generators \[IPG\] and implantable cardioverter defibrillators \[ICD\] both with or without cardiac resynchronization therapy \[+/- CRT\], implantable loop recorders \[ILR\] and leads implanted within intended use. Stratified per country, per pathology, per indication and per device type.

    2013

Study Arms (1)

Patients with Cardiac Rhythm Management device

Patients receiving a Medtronic Cardiac Rhythm Device, worldwide

Device: Cardiac Rhythm Management device

Interventions

Cardiac Rhythm Management deviceDEVICE
Patients with Cardiac Rhythm Management device

Eligibility Criteria

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

Patients receiving market released Medtronic Cardiac Rhythm device, worldwide

You may qualify if:

  • (To be) implanted with a Medtronic market-released cardiac device,
  • Signed Patient Data Release Form.

You may not qualify if:

  • Unwillingness or inability to cooperate or give voluntary consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

C.H.I.R.E.C. - Site de Braine la Alleud

Braine-l'Alleud, Belgium

Location

A.Z. Klina

Brasschaat, Belgium

Location

St. Vincentius-Campus St. Jozef

Mortsel, Belgium

Location

Centre de Medecine Cardiologique

Namur, Belgium

Location

Centre Hosp. Régional du Tournaisis- Site Hopital

Tournai, Belgium

Location

Hôpital Notre Dame de Tournai

Tournai, Belgium

Location

S.A.L. Hospital and Medical Institute

Ahmedabad, India

Location

Max Devki Devi Foundation

New Delhi, India

Location

Chest Disease Hospital

Safat, Kuwait

Location

Regional Clinical Cardio Center

Khabarovsk, Russia

Location

FGU Moscow SRC of Pediatrics & Childrens Surgery

Moscow, Russia

Location

Scientific Center of Heart Surgery by A.N. Bakulev

Moscow, Russia

Location

Scientific Research Institute of Transplantology

Moscow, Russia

Location

Novosibirsk Regional Cardio Center

Novosibirsk, Russia

Location

Scientific Research Institute of Circ. Pathology

Novosibirsk, Russia

Location

Rostov area hospital

Rostov-on-Don, Russia

Location

I.P. Pavlovs State Medical University- Hospital #2

Saint Petersburg, Russia

Location

Medical Academy of Postgraduate Studies

Saint Petersburg, Russia

Location

Scientific Research Insitute of Cardiology

Tomsk, Russia

Location

Tyumen Cardiology Center

Tyumen, Russia

Location

Regional Hospital #1

Vladivostok, Russia

Location

Volgograd cardio center

Volgograd, Russia

Location

Sverlovsk Regional Clinical Hospital N1

Yekaterinburg, Russia

Location

Sweidan Raed King Fahd Armed Forces Hospital

Jeddah, Saudi Arabia

Location

Cardiovascular Institute Dedinje

Beograd (Belgrade), Serbia and Montenegro

Location

Clinical Centre Nis

Nis, Serbia and Montenegro

Location

Instit. of Cardiovasc. Diseases, Univ. of Novi Sad

Sremska Kamenica, Serbia and Montenegro

Location

MeSH Terms

Conditions

Arrhythmias, CardiacSick Sinus SyndromeHeart FailureHeart BlockBradycardiaAtrial FibrillationTachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmia, SinusCardiac Conduction System DiseaseTachycardia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

January 1, 2005

Primary Completion

October 1, 2012

Study Completion

March 1, 2013

Last Updated

July 3, 2025

Record last verified: 2017-09

Locations

KU(1)RU(14)SA(1)SE(3)BE(6)IN(2)