Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00187200

Purpose

The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.

For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

< 10% improvement in 6-minute hall walk, and
no class improvement or worsening in New York Heart Association (NYHA) scale.

For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

> 1 heart failure (HF) related hospitalization, and
no class improvement or worsening in NYHA scale.

Condition	Intervention	Phase
Heart Failure	Device: CRT-D system Device: Optimization of interventricular intervals	Phase IV

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With V-V Timing in Heart Failure Patients

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

CRT responder rate

Secondary Outcome Measures:

6-minute hall walk
Quality of life
Cardiac reverse remodeling
NYHA class progression
Left ventricular ejection fraction (LVEF)
HF related hospitalizations

Estimated Enrollment:	200
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Study Methods

This is a prospective, randomized (simultaneous BiV pacing vs. sequential BiV pacing) study.
Any patient that receives an FDA approved SJM CRT-D with V-V timing is eligible for enrollment.
At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.
Patients are followed for a period of 6 months post randomization:
- Enrollment (1 week pre CRT-D implant to < 2 weeks post CRT-D implant)
- Screening/Randomization Visit (3 months post enrollment)
- Follow-up Visit (6 months post randomization)
Total # of centers - 80 centers
Sample size - 800 patients screened for CRT non-responders (200 randomized patients)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has a standard indication for a CRT-D.
Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
Patient is geographically stable and willing to comply with the required follow-up schedule.
Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
Patients requiring a CRT-D replacement must comply with BOTH of the following:
- > 1 HF related hospitalization
- No class improvement or worsening in NYHA scale

Exclusion Criteria:

Patient's life expectancy is less than 12 months.
Patient has had cardiac surgery within 6 months of enrollment.
Patient has an epicardial ventricular lead system.
Patient is less than 18 years old.
Patient is pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187200

Contacts

Contact: Ashish Oza, MS	(818) 493-3648	aoza@sjm.com
Contact: Ronald LaVallee	818-493-3014

Locations

United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States
Contact: Raul Weiss, MD
Principal Investigator: Raul Weiss, MD

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Raul Weiss, MD

Ohio State University

More Information

No publications provided

Responsible Party:	Ohio State University ( Dr. Raul Weiss )
Study ID Numbers:	CRD299
Study First Received:	September 10, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00187200 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009