Status:
COMPLETED
RethinQ Study - Evaluating Pacing in Heart Failure Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients with heart failure have a pumping action of the ventricles in which one ventricle contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is due to a delay in the st...
Detailed Description
1.0 Problem of Interest Patients with heart failure have a pumping action of the ventricles in which one ventricle contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is...
Eligibility Criteria
Inclusion
- Have an approved indication for implantation of an ICD.
- Have advanced HF with a New York Heart Association (NYHA) Classification of III, despite receiving optimal pharmacological therapy.
- Have a stable heart failure medical regimen.
- Have a left ventricular ejection fraction (LVEF) \<= 35%.
- Have evidence of mechanical dyssynchrony as measured by echocardiography using tissue Doppler imaging or M-mode.
- Have a QRS duration \< 130 ms (present in all ECG leads).
- Have the ability to complete exercise stress testing and 6-minute hall walk test, with the only limiting factors being related to cardiac fitness.
- Have the ability to independently comprehend and complete a quality of life questionnaire.
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion
- Have a standard bradycardic indication for pacing.
- Have been previously treated with CRT.
- Have continuous atrial fibrillation \[AF\] (continuous is defined as AF lasting \> 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month.
- Have the ability to walk \> 450 meters during the 6-minute walk test.
- Have a NYHA Classification of I, II or IV.
- Have symptomatic chronic obstructive pulmonary disease (COPD) as it relates to exercise ability.
- Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 6 months.
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty \[PTCA\] or coronary artery bypass graft \[CABG\]) within 40 days of enrollment.
- Have had a recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment.
- Have severe musculoskeletal disorder(s).
- Pregnant or planning for pregnancy in the next 6 months.
- Currently participating in, or have participated in any clinical investigation within the last 30 days (the only exception being that of a registry trial).
- Have a life expectancy of less than 6 months.
- Less than 18 years of age.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00132977
Start Date
July 1 2005
End Date
July 1 2007
Last Update
February 4 2019
Active Locations (34)
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1
University Hospital University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States, 85251
3
Arkansas Cardiology, PA
Little Rock, Arkansas, United States, 72205
4
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211