RethinQ Study - Evaluating Pacing in Heart Failure Patients

Completed · Phase 3

Conditions studied: Heart Failure

In brief

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 stimulation of the left ventricle because of its increased size. Pacing both the right and the left side of the heart (or cardiac resynchronization therapy \[CRT\]) has been proven to be effective in the treatment of heart failure (HF). Current market-approved devices combine both pacing (CRT) and shocking (implantable cardioverter defibrillator \[ICD\]) therapy for patients who have severe heart failure and are at risk for developing life-threatening heart rhythms. These devices provide an electrical pacing stimulus to both ventricles and may help the heart contract in a more coordinated way and improve heart failure symptoms. The investigational portion of this trial involves the implantation of a market-approved CRT implantable cardioverter defibrillator (CRT-D) system in patients who do not meet the current criteria for a CRT implant. In order to receive a CRT-D implant today, patients must have heart failure symptoms, have a weakened heart muscle, and have uncoordinated pumping of the heart. To demonstrate this uncoordinated pumping of the heart, a test (electrocardiogram \[ECG\]) is done. It is believed that by using a different test (echocardiogram) to measure whether this uncoordinated pumping is present, more patients will be identified that will benefit from CRT-D therapy. This study will look at whether patients identified by using this echocardiogram test show a benefit from having this CRT-D therapy.

Key facts

Study ID: NCT00132977
Run by: Abbott Medical Devices
People needed: 250
Starts: 2005-07-01
Expected to finish: 2007-07-01
Last updated by the study team: 2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University Hospital University of Alabama at Birmingham — Birmingham, Alabama, United States
Arizona Arrhythmia Consultants — Scottsdale, Arizona, United States
Arkansas Cardiology, PA — Little Rock, Arkansas, United States
Arkansas Heart Hospital — Little Rock, Arkansas, United States
Glendale Memorial Hospital and Medical Center — Glendale, California, United States
Scripps Green Hospital — La Jolla, California, United States
Mercy General Hospital — Sacramento, California, United States
St. Francis Hospital and Medical Center — Hartford, Connecticut, United States
Shands Jacksonville — Jacksonville, Florida, United States
Orlando Regional Medical Center — Orlando, Florida, United States
Emory University — Atlanta, Georgia, United States
Unversity of Chicago — Chicago, Illinois, United States
Loyola University Medical Center — Maywood, Illinois, United States
Iowa Heart Center — Des Moines, Iowa, United States
Central Baptist Hospital — Lexington, Kentucky, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Baystate Medical Center — Springfield, Massachusetts, United States
St. John Hospital and Medical Center — Detroit, Michigan, United States
Ingham Regional Medical Center — Lansing, Michigan, United States
United Hospital — Saint Paul, Minnesota, United States
Nebraska Heart Institute — Lincoln, Nebraska, United States
Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
New York Presbyterian Hospital/Cornell University — New York, New York, United States
Mount Sinai Hospital — New York, New York, United States
St. Francis Hospital — Roslyn, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.