Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT00334451
Eligibility Criteria:
Inclusion Criteria:
* Patients who meet current indications for a Guidant RF-enabled CRT-D device (e.g. CONTAK RENEWAL 3 RF family of CRT-D devices) which is compatible with the LATITUDE Communicator. Indications include: NYHA Class III, IV; EF of ≤ 35%; QRS duration of ≥ 120 ms; and optimized pharmacologic therapy
* Patients who have an analog telephone line compatible with the LATITUDE Communicator. The LATITUDE Communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
* Patients who receive the study components including the LATITUDE Communicator, weight scale, and blood pressure monitor
* Patients who are willing and capable of providing informed consent prior to implant and willing to participate in the RAPID-RF Registry
* Patients who remain in the clinical care of a RAPID-RF investigator at approved centers
Exclusion Criteria:
* Patients who are expected to receive a heart transplant during the course of the study
* Patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
* Patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular ICD)
* Patients whose life expectancy is less than 12 months
* Patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the RAPID-RF Registry. Contact Guidant's Clinical Application Research Study (CARS) department to determine eligibility.
* Patients who are younger than 18 years of age
* Patients who are pregnant or plan to become pregnant during the study
* Patients who are unable or refuse to comply with the protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00334451
Study Brief:
Protocol Section:
NCT00334451