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Trial record 72 of 157 for:    Idiopathic Dilated Cardiomyopathy

ACC - Atrial Contribution to CRT

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ClinicalTrials.gov Identifier: NCT00180323
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : November 12, 2012
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dilated Cardiomyopathy
Intervention Device: Renewal
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 43
Completed 43
Not Completed 0
Arm/Group Title Group 1
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  65.1%
>=65 years
15
  34.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
61  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
12
  27.9%
Male
31
  72.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 43 participants
43
1.Primary Outcome
Title Aortic Velocity Time Integral (VTI)
Hide Description Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).
Time Frame At implant (baseline), 3 months and 6 months Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac Resynchronization Therapy ICD (Renewal CRT)
Hide Arm/Group Description:
Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: cm
VTI at baseline intrinsic rhythm 22.4  (7.7)
VTI at baseline intrinsic rhythm + 10 Bpm 21.7  (7.7)
VTI at baseline intrinsic rhythm + 20 Bpm 19.4  (7.5)
VTI at baseline intrinsic rhythm + 30 Bpm 18.1  (7.1)
VTI at 3M Follow-up intrinsic rhythm 23.6  (9.0)
VTI at 3M Follow-up intrinsic rhythm + 10 Bpm 21.9  (9.0)
VTI at 3M Follow-up intrinsic rhythm + 20 Bpm 21.2  (8.1)
VTI at 3M Follow-up intrinsic rhythm + 30 Bpm 19.4  (8.3)
VTI at 6M Follow-up intrinsic rhythm 24.6  (8.4)
VTI at 6M Follow-up intrinsic rhythm + 10 Bpm 23.2  (7.5)
VTI at 6M Follow-up intrinsic rhythm + 20 Bpm 21.7  (7.0)
VTI at 6M Follow-up intrinsic rhythm + 30 Bpm 20.2  (7.2)
2.Primary Outcome
Title Optimal AV-Delay (AVD)
Hide Description Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
Time Frame Implant (baseline), 3 months and 6 months Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac Resynchronization Therapy ICD (Renewal CRT)
Hide Arm/Group Description:
Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: ms
Optimal AVD at baseline intrinsic rhythm 115  (24)
Optimal AVD at baseline intrinsic rhythm +10Bpm 119  (29)
Optimal AVD at baseline intrinsic rhythm +20Bpm 123  (22)
Optimal AVD at baseline intrinsic rhythm +30Bpm 127  (28)
Optimal AVD at 3M intrinsic rhythm 117  (28)
Optimal AVD at 3M intrinsic rhythm +10Bpm 117  (24)
Optimal AVD at 3M intrinsic rhythm +20Bpm 127  (28)
Optimal AVD at 3M intrinsic rhythm +3Bpm 119  (23)
Optimal AVD at 6M intrinsic rhythm 115  (24)
Optimal AVD at 6M intrinsic rhythm +10Bpm 132  (28)
Optimal AVD at 6M intrinsic rhythm +20Bpm 130  (30)
Optimal AVD at 6M intrinsic rhythm +30Bpm 130  (17)
3.Secondary Outcome
Title 6 Minute Walk Test
Hide Description 6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.
Time Frame implant (baseline), 3 months and 6 months Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac Resynchronization Therapy ICD (Renewal CRT)
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6 minute walktest (6 MWT) was performed before implant (baseline ), 3months and 6 months Follow-up.
Overall Number of Participants Analyzed 43
Mean (Standard Error)
Unit of Measure: meter
6 MWT at baseline 388  (88)
6 MWT at 3M Follow-up 470  (87)
6 MWT at 6M Follow-up 497  (83)
4.Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up
Time Frame implant (baseline), 3 Months, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac Resynchronization Therapy ICD (Renewal CRT)
Hide Arm/Group Description:
Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: % of cardiac volume
LVEF at baseline 21  (6)
LVEF at 3M 24  (7)
LVEF at 6M 24  (8)
Time Frame Adverse events were assessed only at implant, 3 months and 6 months follow-up. Events observed between these visits were not provided by the investigator.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Group 1
Affected / at Risk (%)
Total   0/43 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jesper Hastrup Svendsen
Organization: Rigshospitalet, Copenhagen Unviversity Hospital, Denmark
EMail: jesper.hastrup.svendsen@rh.regionh.dk
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180323     History of Changes
Other Study ID Numbers: ACC Version 1.1 11/09/2003
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: March 9, 2012
Results First Posted: November 12, 2012
Last Update Posted: February 3, 2016