FREEDOM
Protocol Number: 06-06-006
Therapeutic Area: Cardiology
Summary:
Patients are enrolled within 2 weeks post CRT-D device implant. All participants must be implanted with an SJM CRT-D device with V-V timing and a compatible lead system. Patients implanted with chronic leads requiring device upgrade to CRT-D can also be enrolled in the study, provided they are receiving a CRT-D device for the first time. Patients are followed up to 12 months post implant with data collected at enrollment, 3 months, 6 months, 9 months, 12 months and at any unscheduled follow-up visits.
Inclusion Criteria:
- Implanted with SJM CRT-D device with W timing and a compatible lead system.
- Ability to complete a 6 minutes hall walk with only limiting factor to be fatigue or SOB.
Exclusion Criteria
- Epicardial ventricular lead system
- Limited intrinsic atrial activity
- Persistent or permanent AF
- 2ο or 3ο heart block
*Additional Eligibility Criteria Exist*
Center Name: Mercy Research Institute at Mercy Hospital
Contact Information: Mercy Research Institute Clinical Trial Coordinators
Address: 3659 South Miami Avenue, Suite 3001, Miami, Florida 33133
Phone: (305) 854-4400, ext. 2312
Fax: (305) 285-2791
E-mail: asilva@mercymiami.org