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TD01 Master Study (Safety and Efficacy Study)

NCT ID: NCT02087189

Last Updated: 2021-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2020-03-31

Brief Summary

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This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.

Detailed Description

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Conditions

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ICD/CRT-D Indication

Keywords

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ICD, CRT-D, lead

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ICD/ CRT-D therapy

First ICD/CRT-D implantation or upgrade from pacemaker

Intervention Type DEVICE

Interventions

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First ICD/CRT-D implantation or upgrade from pacemaker

Intervention Type DEVICE

Other Intervention Names

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TD01 (investigational device) Lumax 540, 640 or 740: VR-T, DR-T or HF-T or Ilesto 5 or Ilesto 7 DF-1: VR-T, DR-T or HF-T or Iforia 3, 5 or Iforia 7 DF-1: VR-T, DR-T or HF-T (or successor) Free choice of additional RA and/or LV lead (if applicable)

Eligibility Criteria

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Inclusion Criteria

* Meet standard indication for ICD/CRT-D therapy
* First ICD/CRT-D implantation or upgrade from pacemaker
* Duly signed informed consent form
* Willing to participate for the whole study duration
* Patient accepts Home Monitoring concept and is able to activate and use the CardioMessenger
* Patient has a legal capacity and ability to consent

Exclusion Criteria

* Meet a standard contraindication for an ICD/CRT-D therapy
* Age \< 18 years
* Pregnant or breast-feeding
* Cardiac surgery planned within the next six months
* Enrollment in another cardiac clinical investigation with active treatment arm
* Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
* Known dexamethasone acetate intolerance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Gunkel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Coordinating Investigator, former PI at the Klinikum Frankfurt (Oder)

Locations

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Kepler Universitätsklinikum

Linz, , Austria

Site Status

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), Brandenburg, Germany

Site Status

Vivantes-Krankenhaus Neukölln

Berlin, , Germany

Site Status

DRK Krankenhaus Chemnitz-Rabenstein

Chemnitz, , Germany

Site Status

Kliniken im Naturpark Altmühltal

Kösching, , Germany

Site Status

Countries

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Austria Germany

Other Identifiers

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TA107

Identifier Type: -

Identifier Source: org_study_id