Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01076348
Other study ID # 4965
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1996
Est. completion date April 2011

Study information

Verified date February 2019
Source Medtronic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).


Description:

As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB

AND one of the following (A, B, or C) must also apply:

A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.

B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:

- product is market-released

- complete implant and follow-up data, including product-related adverse events, are available

- subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.

Exclusion Criteria:

- Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant

- Subjects who are, or will be inaccessible for follow-up at a SLS center

- Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded

- Subjects with exclusion criteria required by local law (EMEA only)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Serbia,  Spain,  Sweden,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Model 4965 Complication Free Rate A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed. 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy