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Predictors of Response to Biventricular Pacing in Heart Failure

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ClinicalTrials.gov Identifier: NCT00156390
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : November 24, 2014
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Samir Saba, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Heart Failure, Wide QRS Complex
Interventions Device: echo-guided left ventricular lead placement
Other: LV lead placement as per standard of care (without echo guidance)
Enrollment 187
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guida
Hide Arm/Group Description

echo-guided LV lead placement

echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance

LV lead placement as per standard of care (without echo-guidance)

placement of the LV lead of the biventricular pacing device without echocardiographic guidance

Period Title: Overall Study
Started 110 77
Completed 96 69
Not Completed 14 8
Arm/Group Title Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guidan Total
Hide Arm/Group Description

echo-guided LV lead placement

echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance

LV lead placement as per standard of care (without echo-guidance)

placement of the LV lead of the biventricular pacing device without echocardiographic guidance

Total of all reporting groups
Overall Number of Baseline Participants 110 77 187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 110 participants 77 participants 187 participants
66
(55 to 77)
67
(54 to 80)
66.5
(54 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 77 participants 187 participants
Female
33
  30.0%
17
  22.1%
50
  26.7%
Male
77
  70.0%
60
  77.9%
137
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants 77 participants 187 participants
110 77 187
1.Primary Outcome
Title Minnesota For Living With Heart Failure Questionnaire
Hide Description Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = "no" heart failure did not prevent one from living as they want and 5= "yes"heart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guidan
Hide Arm/Group Description:

echo-guided LV lead placement

echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance

LV lead placement as per standard of care (without echo-guidance)

placement of the LV lead of the biventricular pacing device without echocardiographic guidance

Overall Number of Participants Analyzed 96 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
31  (26) 24  (20)
2.Secondary Outcome
Title Echocardiographic Changes
Hide Description These parameters compared the echocardiographic measures at baseline prior to device implantations to those obtained 6 to 12 months after device implantation. Data for ESV and EF are presented as percent relative change (standard deviation)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Echo Results. The numbers in the outcome measure data table represent the patients who had both baseline and follow-up echo data. Patients who died or were lost to follow-up before having their follow-up echocardiogram are not included in this analysis.
Arm/Group Title Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guida
Hide Arm/Group Description:

echo-guided LV lead placement

echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance

LV lead placement as per standard of care (without echo-guidance)

placement of the LV lead of the biventricular pacing device without echocardiographic guidance

Overall Number of Participants Analyzed 87 62
Mean (Standard Deviation)
Unit of Measure: percent change
Relative change in ESV (standard deviation) -30  (29) -20  (25)
Relative change in EF (standard deviation) 12  (11) 9  (10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guidan
Hide Arm/Group Description

echo-guided LV lead placement

echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance

LV lead placement as per standard of care (without echo-guidance)

placement of the LV lead of the biventricular pacing device without echocardiographic guidance

All-Cause Mortality
Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guidan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guidan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/110 (28.18%)      36/77 (46.75%)    
Cardiac disorders     
Death  15/110 (13.64%)  15/77 (19.48%) 
Heart Failure Hospitalization  16/110 (14.55%)  21/77 (27.27%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Echo-guided LV Lead Placement LV Lead Placement as Per Standard of Care (Without Echo-guidan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/110 (7.27%)      7/77 (9.09%)    
Injury, poisoning and procedural complications     
Device infection  2/110 (1.82%)  2 1/77 (1.30%)  1
pneumothorax  1/110 (0.91%)  1 0/77 (0.00%)  0
LV lead dislodgement  2/110 (1.82%)  2 2/77 (2.60%)  2
Atrial Lead Dislodgement  0/110 (0.00%)  0 1/77 (1.30%)  1
coronary sinus staining during venography  1/110 (0.91%)  1 1/77 (1.30%)  1
diaphragmatic stimulation from LV pacing requiring device reprogramming  2/110 (1.82%)  2 2/77 (2.60%)  2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Samir Saba
Organization: University of Pittsburgh
Phone: 412-802-3372
EMail: sabas@upmc.edu
Layout table for additonal information
Responsible Party: Samir Saba, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00156390    
Other Study ID Numbers: 0504006
0504006
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: May 21, 2014
Results First Posted: November 24, 2014
Last Update Posted: November 6, 2019