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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00356057
Eligibility Criteria:
Inclusion Criteria:
* Meet the indications for therapy
* Persistent, symptomatic AF with poorly controlled rapid ventricular rates or permanent, symptomatic AF with poorly controlled rapid ventricular rates.
* Eligible for AV nodal ablation and permanent pacemaker implantation
* NYHA Class II or III heart failure
* Age ≥ 18 years
* Understand the nature of the procedure
* Ability to tolerate the surgical procedure required for implantation
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site
Exclusion Criteria:
* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Expected to receive heart transplantation within six months
* Enrolled in another cardiovascular or pharmacological clinical investigation
* Patients with an ICD, or being considered for an ICD
* Patients with previously implanted biventricular pacing systems
* Patients with previously implanted single or dual chamber pacing system with \> 50% documented ventricular pacing
* Patients with previous AV node ablation
* Six-minute walk test distance greater than 450 meters
* Any condition preventing the patient from being able to perform required testing
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Conditions that prohibit placement of any of the lead systems
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00356057
Study Brief:
Protocol Section:
NCT00356057