Optimize RV Selective Site Pacing Clinical Trial

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00422669
• Collaborator: (none)
• Enrollment: 205
• Locations: 22
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Pacing, Artificial; Cardiac Pacemaker, Artificial	Device: Medtronic Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Optimize RV Selective Site Pacing Clinical Trial
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: Medtronic Dual-Chamber Pacemaker; A Medtronic market-approved dual-chamber implantable pulse generator (IPG); Device: Medtronic SelectSecure 3830 Lead; Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
Active Comparator: RV Apical Pacing Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	Device: Medtronic Dual-Chamber Pacemaker; A Medtronic market-approved dual-chamber implantable pulse generator (IPG); Device: Medtronic SelectSecure 3830 Lead; Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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).

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Bridgeport	Connecticut	United States
2		Clearwater	Florida	United States
3		Hudson	Florida	United States
4		Des Moines	Iowa	United States
5		Silver Spring	Maryland	United States
6		Takoma Park	Maryland	United States
7		Southfield	Michigan	United States
8		Saint Paul	Minnesota	United States
9		Omaha	Nebraska	United States
10		Cleveland	Ohio	United States
11		Nashville	Tennessee	United States
12		Dallas	Texas	United States
13		Fort Worth	Texas	United States
14		Tomball	Texas	United States
15		Salt Lake City	Utah	United States
16		Burlington	Vermont	United States
17		Montreal		Canada
18		Hong Kong		China
19		Ramat Gan		Israel
20		Firenze		Italy
21		Rovigo		Italy
22		Doha		Qatar

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Study Chair: Optimize RV Team, Medtronic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00422669
• Other Study ID Numbers: 604
• First Posted: Jan 17, 2007
• Last Update Posted: Jan 31, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: Pacemaker; Implantable Pulse Generator (IPG); AV Conduction Disturbance; Select Site Pacing

Study Results

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 Detail	Seven subjects did not meet inclusion/exclusion criteria.

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet inclusion/exclusion criteria.
Period Title: Overall Study
STARTED	98	100	7
COMPLETED	0	0	0
NOT COMPLETED	98	100	7

Baseline Characteristics

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized	Total
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.	Total of all reporting groups
Overall Participants	98	100	7	205
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	77.1 (11.2)	77.1 (10.5)	NA (NA)	77.1 (10.8)
Gender (participants) [Number]
Female	37 37.8%	39 39%	NA NaN	76 37.1%
Male	61 62.2%	61 61%	NA NaN	122 59.5%
Region of Enrollment (participants) [Number]
United States	75 76.5%	78 78%	7 100%	160 78%
Canada	5 5.1%	6 6%	0 0%	11 5.4%
Israel	5 5.1%	4 4%	0 0%	9 4.4%
Italy	13 13.3%	12 12%	0 0%	25 12.2%

Outcome Measures

1. Primary Outcome

Title	The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

Data required for the analysis were not collected due to early study termination. Analysis will not be done.

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
Measure Participants	0	0	0

2. Secondary Outcome

Title	The Change in LVEF From Two Week Visit to Two Year Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

Data required for the analysis were not collected due to early study termination. Analysis will not be done.

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
Measure Participants	0	0	0

3. Secondary Outcome

Title	The Change in Six-minute Hall Walk Distance
Description	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

Outcome Measure Data

Analysis Population Description

Data required for the analysis were not collected due to early study termination. Analysis will not be done.

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
Measure Participants	0	0	0

4. Secondary Outcome

Title	The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

Data required for the analysis were not collected due to early study termination. Analysis will not be done.

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
Measure Participants	0	0	0

5. Secondary Outcome

Title	Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

Data required for the analysis were not collected due to early study termination. Analysis will not be done.

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
Measure Participants	0	0	0

6. Secondary Outcome

Title	Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

Data required for the analysis were not collected due to early study termination. Analysis will not be done.

Arm/Group Title	RV Mid-Septal Pacing	RV Apical Pacing	Not Randomized
Arm/Group Description	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex	7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
Measure Participants	0	0	0

Adverse Events

Time Frame	All adverse events reported before the study termination were included.
Adverse Event Reporting Description	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".
Arm/Group Title	Subjects With Implant
Arm/Group Description	All 198 subjects with implant were included in this group.
All Cause Mortality
	Subjects With Implant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects With Implant
	Affected / at Risk (%)	# Events
Total	50/198 (25.3%)
Cardiac disorders
Angina pectoris	1/198 (0.5%)	1
Aortic valve stenosis	2/198 (1%)	2
Atrial fibrillation	2/198 (1%)	2
Cardiac arrest	1/198 (0.5%)	1
Cardiac failure	2/198 (1%)	2
Cardiac failure congestive	4/198 (2%)	4
Cardiac perforation	5/198 (2.5%)	5
Cardiac tamponade	1/198 (0.5%)	1
Cardiac valve disease	1/198 (0.5%)	1
Coronary artery disease	2/198 (1%)	2
Coronary artery stenosis	1/198 (0.5%)	1
Intracardiac thrombus	1/198 (0.5%)	1
Myocardial infarction	4/198 (2%)	4
Ventricular fibrillation	1/198 (0.5%)	1
Ventricular tachycardia	1/198 (0.5%)	1
Gastrointestinal disorders
Duodenal ulcer	1/198 (0.5%)	1
Gastrointestinal disorder	1/198 (0.5%)	1
Gastrooesophageal reflux disease	1/198 (0.5%)	1
Ileus	1/198 (0.5%)	1
General disorders
Implant site haematoma	1/198 (0.5%)	1
Hepatobiliary disorders
Cholecystitis	1/198 (0.5%)	1
Infections and infestations
Pneumonia	2/198 (1%)	2
Staphylococcal sepsis	1/198 (0.5%)	1
Viral infection	1/198 (0.5%)	1
Injury, poisoning and procedural complications
Device failure	1/198 (0.5%)	1
Failure to capture	1/198 (0.5%)	1
Lead dislodgement	3/198 (1.5%)	3
Procedural hypertension	1/198 (0.5%)	1
Road traffic accident	1/198 (0.5%)	1
Skin laceration	1/198 (0.5%)	1
Investigations
Ejection fraction decreased	1/198 (0.5%)	1
Metabolism and nutrition disorders
Fluid overload	1/198 (0.5%)	1
Hypoglycemia	2/198 (1%)	2
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	1/198 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/198 (0.5%)	1
Neoplasm malignant	1/198 (0.5%)	1
Rectal cancer	1/198 (0.5%)	1
Nervous system disorders
Cerebrovascular accident	1/198 (0.5%)	1
Hepatic encephalopathy	1/198 (0.5%)	1
Loss of consciousness	1/198 (0.5%)	1
Renal and urinary disorders
Renal artery stenosis	1/198 (0.5%)	1
Renal failure chronic	1/198 (0.5%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/198 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/198 (0.5%)	1
Pleural effusion	1/198 (0.5%)	1
Pneumothorax	3/198 (1.5%)	3
Pulmonary embolism	2/198 (1%)	2
Pulmonary edema	2/198 (1%)	2
Respiratory failure	1/198 (0.5%)	1
Vascular disorders
Deep vein thrombosis	2/198 (1%)	2
Hypertension	1/198 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Subjects With Implant
	Affected / at Risk (%)	# Events
Total	12/198 (6.1%)
Cardiac disorders
Angina pectoris	2/198 (1%)	2
Atrial fibrillation	3/198 (1.5%)	3
Cardiac flutter	1/198 (0.5%)	1
Pacemaker generated arrhythmia	1/198 (0.5%)	1
Gastrointestinal disorders
Abdominal mass	1/198 (0.5%)	1
General disorders
Chest discomfort	1/198 (0.5%)	1
Non-cardiac chest pain	1/198 (0.5%)	1
Infections and infestations
Herpes zoster	1/198 (0.5%)	1
Urinary tract infection	1/198 (0.5%)	1
Injury, poisoning and procedural complications
Lead dislodgement	1/198 (0.5%)	1
Nervous system disorders
Syncope	1/198 (0.5%)	1

Limitations/Caveats

Early study termination due to enrollment rates significantly below protocol expectations.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.