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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02243696
Other study ID # P980023/S057
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 27, 2014
Est. completion date April 17, 2019

Study information

Verified date June 2020
Source Biotronik, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.


Recruitment information / eligibility

Status Terminated
Enrollment 1694
Est. completion date April 17, 2019
Est. primary completion date April 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead

- Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies

- Able to understand the nature of the registry and provide informed consent

- Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up

- Age greater than or equal to 18 years

Exclusion Criteria:

- Enrolled in any investigational cardiac device trial

- Planned cardiac surgical procedures or interventional measures within the next 6 months

- Expected to receive heart transplantation or ventricular assist device within 1 year

- Life expectancy of less than 1 year

- Presence of another life-threatening, underlying illness separate from their cardiac disorder

- Patients reporting pregnancy at the time of enrollment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With No Protego DF4 Lead Adverse Event Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate. Up to 4.5 years
Primary Protego DF4 Lead Safety-Individual Adverse Event-Free Rate Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'. Up to 4.5 years
Secondary Protego DF4 Lead Pacing Threshold Measurement Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up. Up to 4.5 years
Secondary Protego DF4 Lead Shock Impedance Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up. Up to 4.5 years
Secondary Percentage of Subjects With no Adverse Events Excluded From Primary Objectives The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). Up to 4.5 years
Secondary Protego DF4 Lead Sensing Sensing measurements for the Protego DF4 leads through 5 years of follow-up. Up to 4.5 years
Secondary Protego DF4 Lead Pacing Impedance Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up. Up to 4.5 years
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