More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges (MORE-CRT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01510652
First received: November 30, 2011
Last updated: October 22, 2015
Last verified: October 2015
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Postoperative Cardiac Complication
Heart Failure,
Left Ventricular Cardiac Dysfunction
Inappropriate Phrenic Nerve Stimulation
Perioperative/Postoperative Complications
Interventions: Procedure: BiP Group
Device: Quad Group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

1078 patients have been enrolled in this study, while 1074 have been randomized to Quad or BiP group.

The randomization procedure happened after the enrollment and before the implant, this explains why not all 1078 patients have been randomized


Reporting Groups
  Description
Quad Group

Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet

Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet

BiP Group

Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)

Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead


Participant Flow:   Overall Study
    Quad Group     BiP Group  
STARTED     719     355  
Baseline     718     348  
COMPLETED     627     288  
NOT COMPLETED     92     67  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Quad Group

Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet

Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet

BiP Group

Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)

Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead

Total Total of all reporting groups

Baseline Measures
    Quad Group     BiP Group     Total  
Number of Participants  
[units: participants]
  718     348     1066  
Age  
[units: years]
Mean (Standard Deviation)
  67.6  (10.2)     68.4  (9.7)     67.9  (10.1)  
Gender  
[units: participants]
     
Female     173     74     247  
Male     545     274     819  
Left Ventricular Ejection Fraction (LVEF)  
[units: %]
Mean (Standard Deviation)
  27.1  (7.6)     27.5  (8.1)     27.2  (7.7)  
Left Ventricular End-Diastolic Volume (LVEDV)  
[units: ml]
Mean (Standard Deviation)
  200.4  (74.9)     204.5  (72.0)     203.2  (80.6)  
Left Ventricular End-Systolic Volume (LVESV)  
[units: ml]
Mean (Standard Deviation)
  151.2  (64.0)     149.0  (58.3)     150.5  (62.2)  
QRS duration  
[units: ms]
Mean (Standard Deviation)
  158  (29)     157  (27)     157.5  (28.4)  
Cardiomyopathy  
[units: participants]
     
Ischemic     353     196     549  
Non Ischemic     365     152     517  
Atrial Arrhythmia History  
[units: participants]
     
Atrial Fibrillation     114     58     172  
Atrial Flutter     21     7     28  
None     583     283     866  



  Outcome Measures
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1.  Primary:   Lead Performance   [ Time Frame: 6 months ]

2.  Secondary:   Percentage of Cardiac Resynchronization Therapy Responders   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Implant Duration   [ Time Frame: Total duration of the implant procedure reported at the end of the procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients were followed for only 6 months, studies with longer follow-up would add to the body of evidence.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Giuseppe Boriani
Organization: Institute of Cardiology, Univ. of Bologna, Bologna, Italy
e-mail: giuseppe.boriani@unibo.it



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01510652     History of Changes
Other Study ID Numbers: CR-11-006-HF-ID
Study First Received: November 30, 2011
Results First Received: August 14, 2015
Last Updated: October 22, 2015
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Independent Ethics Committee