Cardiac Pacemaker, Artificial, Cardiac Pacing, Artificial
Conditions
Keywords
Pacemaker, Implantable Pulse Generator (IPG), AV Conduction Disturbance, Select Site Pacing
Brief summary
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.
Interventions
DEVICEMedtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time * Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment * Subjects greater than 18 yrs of age * Subjects that are indicated for a dual chamber pacemaker * Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle
Exclusion criteria
* Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines) * Subjects indicated for an implantable cardiac defibrillator (ICD) * Subjects with permanent atrial fibrillation (AF) * Subjects with expected managed ventricular pacing turned on * Subjects with a previously implanted pacemaker, ICD, or CRT device * Subjects with an myocardial infarction (MI) within 3 months prior to enrollment * Subjects that received bypass surgery within 3 months prior to enrollment * Subjects that had valve replacement within 3 months prior to enrollment * Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease * Subjects with a mechanical right heart valve * Women who are pregnant or nursing * Significant co-morbidity preventing study completion * Terminal conditions with a life expectancy of less than two years * Participation in another study that would confound the results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up | Baseline and 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change in LVEF From Two Week Visit to Two Year Follow-up | Baseline and 24 months | 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. |
| The Change in Six-minute Hall Walk Distance | Baseline and 24 months | 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. |
| The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up | Baseline and 24 months | 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). |
| Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up | 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 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. |
| Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up | Baseline and 24 months | 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. |
Countries
Canada, China, Israel, Italy, Qatar, United States
Participant flow
Recruitment details
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.
Pre-assignment details
Seven subjects did not meet inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 98 |
| RV Apical Pacing Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex | 100 |
| Not Randomized 7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized. | 7 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | The study was terminated early. | 98 | 100 | 7 |
Baseline characteristics
| Characteristic | RV Mid-Septal Pacing | RV Apical Pacing | Not Randomized | Total |
|---|---|---|---|---|
| Age Continuous | 77.1 years STANDARD_DEVIATION 11.2 | 77.1 years STANDARD_DEVIATION 10.5 | NA years | 77.1 years STANDARD_DEVIATION 10.8 |
| Gender Female | 37 participants | 39 participants | NA participants | 76 participants |
| Gender Male | 61 participants | 61 participants | NA participants | 122 participants |
| Region of Enrollment Canada | 5 participants | 6 participants | 0 participants | 11 participants |
| Region of Enrollment Israel | 5 participants | 4 participants | 0 participants | 9 participants |
| Region of Enrollment Italy | 13 participants | 12 participants | 0 participants | 25 participants |
| Region of Enrollment United States | 75 participants | 78 participants | 7 participants | 160 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 198 |
| serious Total, serious adverse events | 50 / 198 |
Outcome results
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.
Time frame: Baseline and 24 months
Population: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
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.
Time frame: Baseline and 24 months
Population: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
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.
Time frame: Baseline and 24 months
Population: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
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).
Time frame: Baseline and 24 months
Population: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
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.
Time frame: Baseline and 24 months
Population: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
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.
Time frame: Baseline and 24 months
Population: Data required for the analysis were not collected due to early study termination. Analysis will not be done.