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REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

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ClinicalTrials.gov Identifier: NCT00271154
Recruitment Status : Completed
First Posted : December 30, 2005
Results First Posted : May 13, 2009
Last Update Posted : January 30, 2012
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Heart Failure
Intervention Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
Enrollment 684

Recruitment Details Patients were enrolled from September 2004 through September 2006 at 73 sites located in the United States, Canada, and Europe.
Pre-assignment Details A total of 684 patients were enrolled in the study. Of these, 642 patients were attempted for cardiac resynchronization therapy (CRT) device implant. 21 were unsuccessful, leaving 621 patients successfully implanted with a CRT device. Of these 621 patients, 610 were randomized.
Arm/Group Title CRT OFF CRT ON
Hide Arm/Group Description Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Period Title: Overall Study
Started 191 419
Completed 191 419
Not Completed 0 0
Arm/Group Title CRT OFF CRT ON Total
Hide Arm/Group Description Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy Total of all reporting groups
Overall Number of Baseline Participants 191 419 610
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 419 participants 610 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
108
  56.5%
229
  54.7%
337
  55.2%
>=65 years
83
  43.5%
190
  45.3%
273
  44.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 419 participants 610 participants
61.8  (11.6) 62.9  (10.6) 62.5  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 419 participants 610 participants
Female
39
  20.4%
92
  22.0%
131
  21.5%
Male
152
  79.6%
327
  78.0%
479
  78.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 191 participants 419 participants 610 participants
United States 108 235 343
Spain 9 18 27
Ireland 1 4 5
Austria 2 4 6
United Kingdom 6 9 15
Italy 5 12 17
France 15 34 49
Czech Republic 0 1 1
Hungary 6 13 19
Canada 1 4 5
Belgium 1 3 4
Denmark 19 46 65
Germany 6 11 17
Norway 3 4 7
Sweden 7 17 24
Netherlands 2 4 6
1.Primary Outcome
Title Percentage of Patients Worsened for Clinical Composite Response
Hide Description Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included using Intent to Treat (ITT).
Arm/Group Title CRT OFF CRT ON
Hide Arm/Group Description:
Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Overall Number of Participants Analyzed 191 419
Measure Type: Number
Unit of Measure: Percentage of participants worsened
21.5 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CRT OFF, CRT ON
Comments Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)
Hide Description The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.
Time Frame Baseline to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRT OFF CRT ON
Hide Arm/Group Description:
Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Overall Number of Participants Analyzed 191 419
Mean (Standard Deviation)
Unit of Measure: milliliters per meters squared
-1.3  (23.4) -18.4  (29.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CRT OFF, CRT ON
Comments Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10.
Adverse Event Reporting Description

Serious definition

  • Led to a death,
  • Led to a serious deterioration in health that resulted in:

    • a life-threatening illness or injury,
    • a permanent impairment of a body structure or function
    • hosp. or prolongation of existing hosp.
    • medical or surgical intervention to prevent permanent impairment to body structure or a body function.
 
Arm/Group Title CRT OFF CRT ON Not Randomized
Hide Arm/Group Description Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
All-Cause Mortality
CRT OFF CRT ON Not Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CRT OFF CRT ON Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   122/191 (63.87%)      268/419 (63.96%)      13/38 (34.21%)    
General disorders       
Cardiac failure acute  1  30/191 (15.71%)  52 56/419 (13.37%)  98 2/38 (5.26%)  5
Medical device change  1  19/191 (9.95%)  19 45/419 (10.74%)  46 1/38 (2.63%)  1
Ventricular tachycardia  1  11/191 (5.76%)  14 30/419 (7.16%)  43 1/38 (2.63%)  1
LV lead dislodgement  1  13/191 (6.81%)  15 26/419 (6.21%)  28 2/38 (5.26%)  2
Chest pain  1  4/191 (2.09%)  4 21/419 (5.01%)  25 0/38 (0.00%)  0
Pneumonia  1  8/191 (4.19%)  9 16/419 (3.82%)  19 1/38 (2.63%)  1
Atrial fibrillation  1  8/191 (4.19%)  8 15/419 (3.58%)  19 0/38 (0.00%)  0
Device lead damage  1  8/191 (4.19%)  8 18/419 (4.30%)  18 0/38 (0.00%)  0
Inappropriate device therapy  1  3/191 (1.57%)  3 16/419 (3.82%)  16 0/38 (0.00%)  0
Ventricular fibrillation  1  4/191 (2.09%)  4 8/419 (1.91%)  11 1/38 (2.63%)  1
Cardiac failure chronic  1  5/191 (2.62%)  6 5/419 (1.19%)  6 2/38 (5.26%)  2
Chronic obstructive pulmonary disease  1  3/191 (1.57%)  3 7/419 (1.67%)  11 0/38 (0.00%)  0
RV lead dislodgement  1  1/191 (0.52%)  1 13/419 (3.10%)  13 0/38 (0.00%)  0
Syncope  1  5/191 (2.62%)  7 5/419 (1.19%)  5 1/38 (2.63%)  1
Angina pectoris  1  4/191 (2.09%)  4 8/419 (1.91%)  8 0/38 (0.00%)  0
Atrial flutter  1  6/191 (3.14%)  6 4/419 (0.95%)  5 1/38 (2.63%)  1
Inappropriate device irritation of tissue  1  3/191 (1.57%)  3 9/419 (2.15%)  9 0/38 (0.00%)  0
Cerebrovascular accident  1  4/191 (2.09%)  5 5/419 (1.19%)  6 0/38 (0.00%)  0
Gastrointestinal hemorrhage  1  6/191 (3.14%)  6 4/419 (0.95%)  5 0/38 (0.00%)  0
Hypotension  1  1/191 (0.52%)  1 9/419 (2.15%)  9 1/38 (2.63%)  1
Dyspnea  1  2/191 (1.05%)  3 7/419 (1.67%)  7 0/38 (0.00%)  0
Failure to capture  1  5/191 (2.62%)  6 4/419 (0.95%)  4 0/38 (0.00%)  0
Lead dislodgement  1  0/191 (0.00%)  0 8/419 (1.91%)  10 0/38 (0.00%)  0
RA lead dislodgement  1  2/191 (1.05%)  2 8/419 (1.91%)  8 0/38 (0.00%)  0
Renal failure acute  1  4/191 (2.09%)  4 6/419 (1.43%)  6 0/38 (0.00%)  0
Transient ischemic attack  1  2/191 (1.05%)  2 8/419 (1.91%)  8 0/38 (0.00%)  0
Coronary artery disease  1  4/191 (2.09%)  5 3/419 (0.72%)  3 0/38 (0.00%)  0
Carotid artery stenosis  1  2/191 (1.05%)  2 5/419 (1.19%)  5 0/38 (0.00%)  0
Implant site hematoma  1  1/191 (0.52%)  1 6/419 (1.43%)  6 0/38 (0.00%)  0
Myocardial infarction  1  3/191 (1.57%)  3 4/419 (0.95%)  4 0/38 (0.00%)  0
Osteoarthritis  1  2/191 (1.05%)  2 5/419 (1.19%)  5 0/38 (0.00%)  0
Pneumothorax  1  0/191 (0.00%)  0 5/419 (1.19%)  6 0/38 (0.00%)  0
Acute myocardial infarction  1  1/191 (0.52%)  1 4/419 (0.95%)  4 0/38 (0.00%)  0
Atrial tachycardia  1  1/191 (0.52%)  1 3/419 (0.72%)  3 1/38 (2.63%)  1
Ischemic stroke  1  0/191 (0.00%)  0 3/419 (0.72%)  5 0/38 (0.00%)  0
Pericardial effusion  1  2/191 (1.05%)  2 3/419 (0.72%)  3 0/38 (0.00%)  0
Peripheral vascular disorder  1  1/191 (0.52%)  3 1/419 (0.24%)  1 1/38 (2.63%)  1
Renal failure  1  2/191 (1.05%)  2 3/419 (0.72%)  3 0/38 (0.00%)  0
Sudden cardiac death  1  2/191 (1.05%)  2 3/419 (0.72%)  3 0/38 (0.00%)  0
Acute pulmonary edema  1  0/191 (0.00%)  0 3/419 (0.72%)  3 1/38 (2.63%)  1
Anemia  1  0/191 (0.00%)  0 4/419 (0.95%)  4 0/38 (0.00%)  0
Asthma  1  0/191 (0.00%)  0 2/419 (0.48%)  3 1/38 (2.63%)  1
Atrioventricular block complete  1  0/191 (0.00%)  0 1/419 (0.24%)  1 3/38 (7.89%)  3
Bradycardia  1  1/191 (0.52%)  1 3/419 (0.72%)  3 0/38 (0.00%)  0
Bronchitis  1  0/191 (0.00%)  0 3/419 (0.72%)  4 0/38 (0.00%)  0
Cardiac arrest  1  2/191 (1.05%)  2 2/419 (0.48%)  2 0/38 (0.00%)  0
Cholecystitis acute  1  2/191 (1.05%)  2 2/419 (0.48%)  2 0/38 (0.00%)  0
Deep vein thrombosis  1  2/191 (1.05%)  2 2/419 (0.48%)  2 0/38 (0.00%)  0
Implant site infection  1  2/191 (1.05%)  2 1/419 (0.24%)  2 0/38 (0.00%)  0
Inappropriate device signal detection  1  3/191 (1.57%)  3 1/419 (0.24%)  1 0/38 (0.00%)  0
Ischemic cardiomyopathy  1  1/191 (0.52%)  1 2/419 (0.48%)  2 1/38 (2.63%)  1
Lung neoplasm malignant  1  2/191 (1.05%)  2 2/419 (0.48%)  2 0/38 (0.00%)  0
Respiratory failure  1  1/191 (0.52%)  1 3/419 (0.72%)  3 0/38 (0.00%)  0
Acute respiratory failure  1  2/191 (1.05%)  2 1/419 (0.24%)  1 0/38 (0.00%)  0
Angina unstable  1  0/191 (0.00%)  0 3/419 (0.72%)  3 0/38 (0.00%)  0
Aortic aneurysm  1  2/191 (1.05%)  2 1/419 (0.24%)  1 0/38 (0.00%)  0
Atrioventricular block third degree  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Back pain  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Bronchitis acute  1  0/191 (0.00%)  0 3/419 (0.72%)  3 0/38 (0.00%)  0
Cardiac perforation  1  0/191 (0.00%)  0 2/419 (0.48%)  2 1/38 (2.63%)  1
Cardiac tamponade  1  1/191 (0.52%)  1 1/419 (0.24%)  1 1/38 (2.63%)  1
Contusion  1  1/191 (0.52%)  1 1/419 (0.24%)  1 1/38 (2.63%)  1
Defibrillation threshold increased  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Dehydration  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Dizziness  1  0/191 (0.00%)  0 2/419 (0.48%)  3 0/38 (0.00%)  0
Esophageal carcinoma  1  0/191 (0.00%)  0 3/419 (0.72%)  3 0/38 (0.00%)  0
Hematoma  1  0/191 (0.00%)  0 3/419 (0.72%)  3 0/38 (0.00%)  0
Intracardiac thrombus  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Myocardial ischemia  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Non-cardiac chest pain  1  0/191 (0.00%)  0 3/419 (0.72%)  3 0/38 (0.00%)  0
Pericarditis  1  0/191 (0.00%)  0 2/419 (0.48%)  3 0/38 (0.00%)  0
Presyncope  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Prostate examination abnormal  1  0/191 (0.00%)  0 3/419 (0.72%)  3 0/38 (0.00%)  0
Pulmonary edema  1  2/191 (1.05%)  2 1/419 (0.24%)  1 0/38 (0.00%)  0
Subclavian vein thrombosis  1  1/191 (0.52%)  1 2/419 (0.48%)  2 0/38 (0.00%)  0
Therapeutic agent toxicity  1  1/191 (0.52%)  2 1/419 (0.24%)  1 0/38 (0.00%)  0
Anxiety  1  0/191 (0.00%)  0 1/419 (0.24%)  1 1/38 (2.63%)  1
Aortic stenosis  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Arrhythmia supraventricular  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Arteriovenous fistula  1  0/191 (0.00%)  0 1/419 (0.24%)  1 1/38 (2.63%)  1
Biliary colic  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Cholecystitis  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Cholelithiasis  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Coronary artery dissection  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Coronary artery stenosis  1  2/191 (1.05%)  2 0/419 (0.00%)  0 0/38 (0.00%)  0
Death  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Diabetes mellitus  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Diabetes mellitus inadequate control  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Drug hypersensitivity  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Drug toxicity  1  1/191 (0.52%)  2 0/419 (0.00%)  0 0/38 (0.00%)  0
Dyspnea exertional  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Electromechanical dissociation  1  1/191 (0.52%)  1 0/419 (0.00%)  0 1/38 (2.63%)  1
Fatigue  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Heart transplant  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Hyperglycemia  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Inappropriate device stimulation of tissue  1  2/191 (1.05%)  2 0/419 (0.00%)  0 0/38 (0.00%)  0
Mental status changes  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Mitral valve incompetence  1  0/191 (0.00%)  0 1/419 (0.24%)  2 0/38 (0.00%)  0
Orthostatic hypotension  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Oversensing  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Paraesthesia  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Pneumonia aspiration  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Postoperative wound infection  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Pulmonary embolism  1  0/191 (0.00%)  0 1/419 (0.24%)  2 0/38 (0.00%)  0
Pulmonary fibrosis  1  0/191 (0.00%)  0 1/419 (0.24%)  2 0/38 (0.00%)  0
Sepsis  1  1/191 (0.52%)  1 1/419 (0.24%)  1 0/38 (0.00%)  0
Syncope vasovagal  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Tachycardia  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Urinary tract infection  1  0/191 (0.00%)  0 2/419 (0.48%)  2 0/38 (0.00%)  0
Abdominal abscess  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Abdominal discomfort  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Abdominal pain upper  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Acute coronary syndrome  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Adverse drug reaction  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Ankle fracture  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Anorexia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Anxiety disorder  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Aortic thrombosis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Arrhythmia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Arterial disorder  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Arterial stenosis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Arteriogram coronary  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Arteriopathic disease  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Arthralgia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Asthenia  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Bacteraemia  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Balance disorder  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Biopsy liver  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Bronchopulmonary aspergillosis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Cardiac ablation  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Cardiac failure  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Cardiac procedure complication  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Cardio-renal syndrome  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Cardiomyopathy  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Cardiomyopathy alcoholic  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Cellulitis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Cervical dysplasia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Chest discomfort  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Colon cancer  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Colonic obstruction  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Colostomy  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Constipation  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Contrast media reaction  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Convulsion  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Coronary artery restenosis  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Decreased RV Sensing  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Depressed level of consciousness  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Device electrical finding  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Device migration  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Device related infection  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Diabetes mellitus insulin-dependent  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Dislodgement of LV lead  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Diverticulitis esophageal  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Duodenal ulcer  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Edema peripheral  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Elevated pacing threshold  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Endocarditis  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Epistaxis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Extrasystoles  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Fluid overload  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Gastroenteritis  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
General physical health deterioration  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Goiter  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Hairy cell leukemia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Headache  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hematoma evacuation  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hemianopsia homonymous  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Hemoglobin decreased  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Hemorrhage  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hemorrhoids  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hepatic function abnormal  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hip arthroplasty  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hypersensitivity  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hyperthyroidism  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hypervolemic  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hypoglycemia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hypokalemia  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Hyponatremia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hypothyroidism  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Hypoxia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Implant site erosion  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Implant site inflammation  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Implant site irritation  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
In-stent arterial restenosis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Incision site complication  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Infection  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Inguinal hernia repair  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Intermittent claudication  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Intestinal obstruction  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Iodine allergy  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Joint dislocation  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Joint swelling  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Knee arthroplasty  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Leukothrombopenia  1  0/191 (0.00%)  0 0/419 (0.00%)  0 1/38 (2.63%)  1
Low cardiac output syndrome  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Lower respiratory tract infection  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Lower respiratory tract infection viral  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Lumbar spinal stenosis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Lung adenocarcinoma  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Lung consolidation  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Malaise  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Medical device complication  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Melaena  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Metastases to bone  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Metastatic neoplasm  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Mitral valve disease  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Mitral valve repair  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Multi-organ failure  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Musculoskeletal chest pain  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Neoplasm malignant  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Nephrolithiasis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Nodal arrhythmia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Orthostatic intolerance  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Oxygen saturation decreased  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Palpitations  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Perianal abscess  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Peripheral arterial occlusive disease  1  0/191 (0.00%)  0 0/419 (0.00%)  0 1/38 (2.63%)  1
Peripheral ischemia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Phlebitis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Pituitary tumor  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Pleural effusion  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Polyneuropathy  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Prostate cancer  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Pulmonary hypertension  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Pulmonary mass  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Rectal hemorrhage  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Renal cancer metastatic  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Renal impairment  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Retinal detachment  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Retroperitoneal hemorrhage  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Sinusitis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Sinusitis  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Skin irritation  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Skin ulcer  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Small cell lung cancer stage unspecified  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Small intestinal obstruction  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Spondylolysis  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Squamous cell carcinoma  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Subarachnoid hemorrhage  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Subdural hematoma  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Supraventricular tachycardia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Throat lesion  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Thrombocytopenia  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Tonsillar disorder  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Tooth disorder  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Twiddler's syndrome  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Urinary bladder adenoma  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Valvuloplasty cardiac  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Vascular pseudoaneurysm  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Venous stenosis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Ventricular arrhythmia  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Ventricular assist device insertion  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Vertigo CNS origin  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Vestibular neuronitis  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Viral infection  1  1/191 (0.52%)  1 0/419 (0.00%)  0 0/38 (0.00%)  0
Vocal cord polyp  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Vocal cord thickening  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Wound dehiscence  1  0/191 (0.00%)  0 1/419 (0.24%)  1 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CRT OFF CRT ON Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/119 (51.26%)      140/491 (28.51%)      2/38 (5.26%)    
General disorders       
Cardiac failure chronic  1  24/119 (20.17%)  30 31/491 (6.31%)  35 1/38 (2.63%)  1
Atrial fibrillation  1  8/119 (6.72%)  8 47/491 (9.57%)  57 0/38 (0.00%)  0
Dizziness  1  9/119 (7.56%)  9 25/491 (5.09%)  29 1/38 (2.63%)  1
Inappropriate device stimulation of tissue  1  11/119 (9.24%)  12 21/491 (4.28%)  25 0/38 (0.00%)  0
Inappropriate device irritation of tissue  1  4/119 (3.36%)  4 26/491 (5.30%)  30 1/38 (2.63%)  1
Hypotension  1  10/119 (8.40%)  12 16/491 (3.26%)  16 0/38 (0.00%)  0
Fatigue  1  12/119 (10.08%)  12 15/491 (3.05%)  15 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether confidential information ("CI") is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.
Results Point of Contact
Name/Title: CRDM Core Clinical
Organization: Medtronic CRDM
Phone: 800-328-2518
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00271154     History of Changes
Other Study ID Numbers: 233
First Submitted: December 21, 2005
First Posted: December 30, 2005
Results First Submitted: December 24, 2008
Results First Posted: May 13, 2009
Last Update Posted: January 30, 2012