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Study enrollment significantly below protocol expectations
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The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV Mid-Septal Pacing | Active Comparator | Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart |
|
| RV Apical Pacing | Active Comparator | Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Dual-Chamber Pacemaker | Device | A Medtronic market-approved dual-chamber implantable pulse generator (IPG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up | Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in LVEF From Two Week Visit to Two Year Follow-up | Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Optimize RV Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport | Connecticut | United States | ||||
Seven subjects did not meet inclusion/exclusion criteria.
Enrollments in the Optimize RV trial began in March of 2007. The study was terminated early on March 26, 2009 after 205 subjects had been enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | RV Mid-Septal Pacing | Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart |
| FG001 | RV Apical Pacing | Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Medtronic SelectSecure 3830 Lead | Device | Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead |
|
| Baseline and 24 months |
| The Change in Six-minute Hall Walk Distance | The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance. | Baseline and 24 months |
| The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up | LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume). | Baseline and 24 months |
| Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up | Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate. | Baseline and 24 months |
| Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up | Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate. | Baseline and 24 months |
| Clearwater |
| Florida |
| United States |
| Hudson | Florida | United States |
| Des Moines | Iowa | United States |
| Silver Spring | Maryland | United States |
| Takoma Park | Maryland | United States |
| Southfield | Michigan | United States |
| Saint Paul | Minnesota | United States |
| Omaha | Nebraska | United States |
| Cleveland | Ohio | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Tomball | Texas | United States |
| Salt Lake City | Utah | United States |
| Burlington | Vermont | United States |
| Montreal | Canada |
| Hong Kong | China |
| Ramat Gan | Israel |
| Florence | Italy |
| Rovigo | Italy |
| Doha | Qatar |
| FG002 | Not Randomized | 7 of the 205 subjects did not meet inclusion/exclusion criteria. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RV Mid-Septal Pacing | Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart |
| BG001 | RV Apical Pacing | Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex |
| BG002 | Not Randomized | 7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up | Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF. | Data required for the analysis were not collected due to early study termination. Analysis will not be done. | Posted | Baseline and 24 months |
|
| |||||||||||||||||||||||||
| Secondary | The Change in LVEF From Two Week Visit to Two Year Follow-up | Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF. | Data required for the analysis were not collected due to early study termination. Analysis will not be done. | Posted | Baseline and 24 months |
| ||||||||||||||||||||||||||
| Secondary | The Change in Six-minute Hall Walk Distance | The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance. | Data required for the analysis were not collected due to early study termination. Analysis will not be done. | Posted | Baseline and 24 months |
| ||||||||||||||||||||||||||
| Secondary | The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up | LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume). | Data required for the analysis were not collected due to early study termination. Analysis will not be done. | Posted | Baseline and 24 months |
| ||||||||||||||||||||||||||
| Secondary | Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up | Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate. | Data required for the analysis were not collected due to early study termination. Analysis will not be done. | Posted | Baseline and 24 months |
| ||||||||||||||||||||||||||
| Secondary | Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up | Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate. | Data required for the analysis were not collected due to early study termination. Analysis will not be done. | Posted | Baseline and 24 months |
|
All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee.
All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
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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 | Subjects With Implant | All 198 subjects with implant were included in this group. | 50 | 198 | 12 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (10.1) |
| ||
| Aortic valve stenosis | Cardiac disorders | MedDRA (10.1) |
| ||
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) |
| ||
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (10.1) |
| ||
| Cardiac arrest | Cardiac disorders | MedDRA (10.1) |
| ||
| Cardiac failure | Cardiac disorders | MedDRA (10.1) |
| ||
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.1) |
| ||
| Cardiac perforation | Cardiac disorders | MedDRA (10.1) |
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| Cardiac tamponade | Cardiac disorders | MedDRA (10.1) |
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| Cardiac valve disease | Cardiac disorders | MedDRA (10.1) |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (10.1) |
| ||
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
| ||
| Coronary artery disease | Cardiac disorders | MedDRA (10.1) |
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| Coronary artery stenosis | Cardiac disorders | MedDRA (10.1) |
| ||
| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) |
| ||
| Device failure | Injury, poisoning and procedural complications | MedDRA (10.1) |
| ||
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (10.1) |
| ||
| Ejection fraction decreased | Investigations | MedDRA (10.1) |
| ||
| Failure to capture | Injury, poisoning and procedural complications | MedDRA (10.1) |
| ||
| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.1) |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (10.1) |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (10.1) |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA (10.1) |
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| Hypertension | Vascular disorders | MedDRA (10.1) |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.1) |
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| Ileus | Gastrointestinal disorders | MedDRA (10.1) |
| ||
| Implant site haematoma | General disorders | MedDRA (10.1) |
| ||
| Intracardiac thrombus | Cardiac disorders | MedDRA (10.1) |
| ||
| Lead dislodgement | Injury, poisoning and procedural complications | MedDRA (10.1) |
| ||
| Loss of consciousness | Nervous system disorders | MedDRA (10.1) |
| ||
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) |
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| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
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| Pneumonia | Infections and infestations | MedDRA (10.1) |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
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| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (10.1) |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) |
| ||
| Renal artery stenosis | Renal and urinary disorders | MedDRA (10.1) |
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| Renal failure chronic | Renal and urinary disorders | MedDRA (10.1) |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
| ||
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.1) |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (10.1) |
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| Staphylococcal sepsis | Infections and infestations | MedDRA (10.1) |
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| Ventricular fibrillation | Cardiac disorders | MedDRA (10.1) |
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| Ventricular tachycardia | Cardiac disorders | MedDRA (10.1) |
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| Viral infection | Infections and infestations | MedDRA (10.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal mass | Gastrointestinal disorders | MedDRA (10.1) |
| ||
| Angina pectoris | Cardiac disorders | MedDRA (10.1) |
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| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) |
| ||
| Cardiac flutter | Cardiac disorders | MedDRA (10.1) |
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| Chest discomfort | General disorders | MedDRA (10.1) |
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| Herpes zoster | Infections and infestations | MedDRA (10.1) |
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| Lead dislodgement | Injury, poisoning and procedural complications | MedDRA (10.1) |
| ||
| Non-cardiac chest pain | General disorders | MedDRA (10.1) |
| ||
| Pacemaker generated arrhythmia | Cardiac disorders | MedDRA (10.1) |
| ||
| Syncope | Nervous system disorders | MedDRA (10.1) |
| ||
| Urinary tract infection | Infections and infestations | MedDRA (10.1) |
|
Early study termination due to enrollment rates significantly below protocol expectations.
In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigational Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Optimize RV Trial Leader | Medtronic, Inc. | 1-800-328-2518 | medtroniccrmtrials@medtronic.com |
| Male |
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| Canada |
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| Israel |
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| Italy |
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