DF4 Master Study (Safety and Efficacy Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Linox Smart S DX PME/Master Study

NCT01090401

ICD Indication

COMPLETED PHASE4

SD01 Master Study (Safety and Efficacy Study)

NCT01836497

Ventricular Tachycardia Ventricular Fibrillation Heart Failure

COMPLETED

TD01 Master Study (Safety and Efficacy Study)

NCT02087189

ICD/CRT-D Indication

COMPLETED

MODULA Modul 5 BEAT-HF

NCT00273091

Heart Failure

COMPLETED

ProMRI Study of the Iforia ICD System (Phase C)

NCT02096692

Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Tachycardia Ventricular Fibrillation Sudden Cardiac Death Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICD system with DF4 connection

Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego

Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Intervention Type DEVICE

ICD system with DF-1 connection

Ilesto/Iforia ICD with DF-1 connection

Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient has provided written informed consent.
* Patient has standard ICD/CRT-D indication.
* Patient accepts Home Monitoring concept.
* Patient is able to attend the planned hospital follow-up visits.
* Patient has legal capacity and ability to consent.

Exclusion Criteria

* Patient has a standard contra-indication for ICD/CRT-D therapy.
* Age \< 18 years
* Patient is pregnant or breastfeeding.
* Patient is expected to receive ventricular assist device or heart transplantation within the next 12 months.
* Life expectancy of less than 12 months.
* Participating in any other clinical study of an investigational cardiac drug or device.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No