Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following (Cogent-4)
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ClinicalTrials.gov Identifier: NCT00606710 |
Recruitment Status :
Completed
First Posted : February 4, 2008
Last Update Posted : November 24, 2008
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Condition or disease | Intervention/treatment |
---|---|
Ventricular Tachycardia, Ventricular Fibrillation Heart Failure | Device: Cognis 100-D, Teligen DR, VR 100 HE |
Study Type : | Observational |
Estimated Enrollment : | 450 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

- Device: Cognis 100-D, Teligen DR, VR 100 HE
ICD or CRT - TherapyOther Name: Reliance Quadripolar Defibrillation Lead
- Appropriate detection of ventricular arrhythmias [ Time Frame: Predischarge ]
- Appropriate shock conversion [ Time Frame: Predischarge ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- ICD indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
- CRT-D indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
- Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
- Geographically stable patients who are available for follow-up at a study centre
- Age 18 or above, or of legal age to give informed consent specific to national law
Exclusion Criteria:
- Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- Patients currently requiring dialysis
- Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
- Enrolled in any concurrent study
- Patients implanted with the following leads which will not be abandoned:
- Atrial or right ventricular unipolar leads
- Patch defibrillation leads
- Non-compatible defibrillation leads (e.g. 5/6mm)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606710
Denmark | |
KAS Gentofte Hospital | |
Hellerup, Denmark, 2900 | |
Israel | |
Barzilay Medical Center | |
Ashkelon, Israel, 78306 | |
Tel Aviv Medical Center | |
Tel Aviv, Israel, 64239 | |
Sheba Medical Center | |
Tel Hashomer, Israel, 52621 |
Principal Investigator: | Poul Erik Bloch Thomsen, MD | KAS Gentofte Hospital |
Responsible Party: | Torsten Kayser, Boston Scientific |
ClinicalTrials.gov Identifier: | NCT00606710 |
Other Study ID Numbers: |
Cogent-4 0806 |
First Posted: | February 4, 2008 Key Record Dates |
Last Update Posted: | November 24, 2008 |
Last Verified: | November 2008 |
Tachycardia Tachycardia, Ventricular Ventricular Fibrillation Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Cardiac Conduction System Disease Pathologic Processes |