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The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QuickOpt (Treatment) | Experimental | Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. |
|
| Control | Active Comparator | Empiric programming or one-time optimization using a non-IEGM method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Device | Empiric programming or one-time optimization using a non-IEGM method. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Clinical Composite Score | The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause, Cardiovascular and Heart Failure Mortality; | 12 months | |
| All Cause, Cardiovascular and Heart Failure Hospitalization | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Abraham, MD | Ohio State University, Columbus, OH, USA | Principal Investigator |
| Daniel Gras, MD | Nouvelles Cliniques Nantaises, Nantes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Hospital | Los Angeles | California | 90048 | United States | ||
| Ohio State Univeristy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20569704 | Derived | Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034. |
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| ID | Title | Description |
|---|---|---|
| FG000 | QuickOpt (Treatment) | Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. |
| FG001 | Control | Empiric programming or one-time optimization using a non-IEGM method. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Date of birth missing for 1 treatment patient and 1 control patient.
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| ID | Title | Description |
|---|---|---|
| BG000 | QuickOpt (Treatment) | Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. |
| BG001 | Control | Empiric programming or one-time optimization using a non-IEGM method. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Failure Clinical Composite Score | The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse. | Posted | Number | participants | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QuickOpt (Treatment) | Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Angiogram | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary Arrest | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director Clinical Studies | St. Jude Medical | (408) 522-6410 | tshipman@sjm.com |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| QuickOpt |
| Device |
Frequent optimization using QuickOpt to optimize AV/PV and VV delays. |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Empiric programming or one-time optimization using a non-IEGM method. |
|
|
| Secondary | All-cause, Cardiovascular and Heart Failure Mortality; | Per protocol | Posted | Number | participants | 12 months |
|
|
|
| Secondary | All Cause, Cardiovascular and Heart Failure Hospitalization | Posted | Number | participants | 12 months |
|
|
|
| 120 |
| 816 |
| 184 |
| 816 |
| EG001 | Control | Empiric programming or one-time optimization using a non-IEGM method. | 111 | 828 | 177 | 828 |
| Cardiopulmonary Arrest | Cardiac disorders |
|
| Arrhythmias | Cardiac disorders |
|
| Cardiac Perforation | Cardiac disorders |
|
| Thrombosis | Cardiac disorders |
|
| Chest pain/MI | Cardiac disorders |
|
| Coronary Sinus Dissection | Cardiac disorders |
|
| Death | Cardiac disorders |
|
| Device migration/malfunction | Cardiac disorders |
|
| Elevated Pacing Thresholds | Cardiac disorders |
|
| Erosion/Pocket Pain | Cardiac disorders |
|
| Hematoma | Cardiac disorders |
|
| Infection | Cardiac disorders |
|
| Lead Dislodgment/Migration | Cardiac disorders |
|
| Lead Fracture/Insulation Damage | Cardiac disorders |
|
| Oversensing/Undersensing | Cardiac disorders |
|
| Phrenic Nerve/Diaphragmatic Nerve Stimulation | Cardiac disorders |
|
| Therapy for non-ventricular rhythm | Cardiac disorders |
|
| Valve replacement | Cardiac disorders |
|
| Other cardiac | Cardiac disorders |
|
| Endocrine disorders | Endocrine disorders |
|
| Rectal Bleeding | Gastrointestinal disorders |
|
| Joint pain | Musculoskeletal and connective tissue disorders |
|
| CVA/TIA | Nervous system disorders |
|
| Neurologic other | Nervous system disorders |
|
| DVT | Vascular disorders |
|
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory other | Respiratory, thoracic and mediastinal disorders |
|
| Arrhythmias | Cardiac disorders |
|
| Elevated Pacing Thresholds | Cardiac disorders |
|
| Undersensing/Oversensing | Cardiac disorders |
|
| Heart Failure | Cardiac disorders |
|
| Hematoma | Cardiac disorders |
|
| Infection | Cardiac disorders |
|
| Lead Dislodgement/Migration | Cardiac disorders |
|
| MI | Cardiac disorders |
|
| Phrenic Nerve/Diaphragmatic Nerve Stimulation | Cardiac disorders |
|
| Syncope | Nervous system disorders |
|
| Therapy for non-ventricular rhythm | Cardiac disorders |
|
Publications and presentations proposed by participating centers should be furnished to sponsor for review and comment 30 days (manuscripts) or 7 days (abstracts) prior to submission for publication. Sponsor reserves the right to deny submission of study results if based on data owned by sponsor.