More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges (MORE-CRT)
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|ClinicalTrials.gov Identifier: NCT01510652|
Recruitment Status : Completed
First Posted : January 16, 2012
Results First Posted : October 23, 2015
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Cardiac Complication Heart Failure Left Ventricular Cardiac Dysfunction Inappropriate Phrenic Nerve Stimulation Perioperative/Postoperative Complications||Procedure: BiP Group Device: Quad Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1078 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Active Comparator: Quad Group
Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Device: Quad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet
Active Comparator: 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)
Procedure: BiP Group
Implantation of standard Left Ventricular (LV) lead
- Lead Performance [ Time Frame: 6 months ]
Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.
Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.
- Percentage of Cardiac Resynchronization Therapy Responders [ Time Frame: Baseline and 6 months ]Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
- Implant Duration [ Time Frame: Total duration of the implant procedure reported at the end of the procedure ]This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510652
|Principal Investigator:||Giuseppe Boriani, Pro.||Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy|