RethinQ Study - Evaluating Pacing in Heart Failure Patients (RethinQ)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, Heart Failure, Mechanical Dyssynchrony
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- University Hospital University of Alabama at Birmingham
- Arizona Arrhythmia Consultants
- Arkansas Cardiology, PA
- Arkansas Heart Hospital
- Glendale Memorial Hospital and Medical Center
- Scripps Green Hospital
- Mercy General Hospital
- St. Francis Hospital and Medical Center
- Shands Jacksonville
- Orlando Regional Medical Center
- Emory University
- Unversity of Chicago
- Loyola University Medical Center
- Iowa Heart Center
- Central Baptist Hospital
- Massachusetts General Hospital
- Baystate Medical Center
- St. John Hospital and Medical Center
- Ingham Regional Medical Center
- United Hospital
- Nebraska Heart Institute
- Deborah Heart and Lung Center
- New York Presbyterian Hospital/Cornell University
- Mount Sinai Hospital
- St. Francis Hospital
- University Hospitals of Cleveland
- Cleveland Clinic Foundation
- The Ohio State University
- Elyria Regional Medical Center
- Hospital of the University of Pennsylvania
- Main Line Health Center/Lankenau Hospital
- Medical University of Southern California
- Stern Cardiovascular Center
- St. Thomas Hospital