Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132977
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2005-08-18
Brief Title:
RethinQ Study - Evaluating Pacing in Heart Failure Patients
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Resynchronization Therapy in Normal QRS RethinQ Clinical Investigation
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RethinQ
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 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
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
Detailed Description:
10 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 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 Current market-approved devices combine both pacing CRT and shocking 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 at the same time 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 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
20 Study Summary
Testing will be performed to determine if patients are eligible for this study An EKG electrical tracing of the heart will be performed They will be asked to complete a 6- minute hall walk test that will provide information regarding their ability to exercise and conduct daily activities An echocardiogram with tissue Doppler imaging ultrasound of the heart will be performed to determine how the heart muscle contracts Results of this echocardiogram will determine if patients are eligible to participate in this study
The device system that will be implanted consists of a St Jude Medical CRT-D and three pacing leads insulted wires that carry electrical energy from the device to the heart One lead is placed in the upper right chamber of the heart atrium a second lead is placed in the lower right chamber of the heart right ventricle and the third lead is placed within a vein that runs along the outside of the heart and is positioned at a location near the left lower chamber of the heart left ventricle
A randomization visit will occur approximately 14 days after implant Patients will be randomized like a flip of a coin to one of two groups Each patient will have an equal chance of being randomized to either of the two groups One group will receive cardiac resynchronization treatment CRT ON and the other group will not receive cardiac resynchronization treatment CRT OFF Patients in the CRT OFF group can receive cardiac resynchronization treatment at 6 months after randomization if the doctor determines that it is appropriate
Prior to randomization and programming of the device the following tests will be completed
Quality of Life Questionnaire - contains 21 questions that provide information as to how heart failure affects the patients daily life
EKG
6-Minute Hall
Cardiopulmonary Exercise Stress Testing CPX - measures the amount of oxygen used by your body while exercising on a treadmill and breathing through a special breathing tube
Echocardiogram
Follow-up visits will occur at 3 and 6 months following randomization and every 6 months thereafter until the end of the study The tests performed at the randomization visit Quality of Life Questionnaire EKG 6 minute hall walk CPX and echocardiogram will be repeated at the 6-month follow-up visit Additionally each visit will include a review of the patients condition and current medications and an evaluation of the CRT-D device
30 How Will the Research Advance Scientific Knowledge andor Human Health
It is hoped that by pacing both lower chambers of the heart in these patients that they will feel better They may be able to do more activities with fewer symptoms In addition the information gathered in this study will add to the understanding of treatment options for patients with heart failure
40 What is the Current Standard of Care
Alternative treatments to the St Jude Medical CRT-D system includes the left heart lead currently available include implantation of a standard ICD system andor treatment with medications
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 Current market-approved devices combine both pacing CRT and shocking 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 at the same time 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 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
20 Study Summary
Testing will be performed to determine if patients are eligible for this study An EKG electrical tracing of the heart will be performed They will be asked to complete a 6- minute hall walk test that will provide information regarding their ability to exercise and conduct daily activities An echocardiogram with tissue Doppler imaging ultrasound of the heart will be performed to determine how the heart muscle contracts Results of this echocardiogram will determine if patients are eligible to participate in this study
The device system that will be implanted consists of a St Jude Medical CRT-D and three pacing leads insulted wires that carry electrical energy from the device to the heart One lead is placed in the upper right chamber of the heart atrium a second lead is placed in the lower right chamber of the heart right ventricle and the third lead is placed within a vein that runs along the outside of the heart and is positioned at a location near the left lower chamber of the heart left ventricle
A randomization visit will occur approximately 14 days after implant Patients will be randomized like a flip of a coin to one of two groups Each patient will have an equal chance of being randomized to either of the two groups One group will receive cardiac resynchronization treatment CRT ON and the other group will not receive cardiac resynchronization treatment CRT OFF Patients in the CRT OFF group can receive cardiac resynchronization treatment at 6 months after randomization if the doctor determines that it is appropriate
Prior to randomization and programming of the device the following tests will be completed
Quality of Life Questionnaire - contains 21 questions that provide information as to how heart failure affects the patients daily life
EKG
6-Minute Hall
Cardiopulmonary Exercise Stress Testing CPX - measures the amount of oxygen used by your body while exercising on a treadmill and breathing through a special breathing tube
Echocardiogram
Follow-up visits will occur at 3 and 6 months following randomization and every 6 months thereafter until the end of the study The tests performed at the randomization visit Quality of Life Questionnaire EKG 6 minute hall walk CPX and echocardiogram will be repeated at the 6-month follow-up visit Additionally each visit will include a review of the patients condition and current medications and an evaluation of the CRT-D device
30 How Will the Research Advance Scientific Knowledge andor Human Health
It is hoped that by pacing both lower chambers of the heart in these patients that they will feel better They may be able to do more activities with fewer symptoms In addition the information gathered in this study will add to the understanding of treatment options for patients with heart failure
40 What is the Current Standard of Care
Alternative treatments to the St Jude Medical CRT-D system includes the left heart lead currently available include implantation of a standard ICD system andor treatment with medications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None