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 |
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Recruitment Status :
Completed
First Posted : January 16, 2012
Results First Posted : October 23, 2015
Last Update Posted : February 15, 2019
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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Brief Summary:
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Quad Group
Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
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Device: Quad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet |
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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)
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Procedure: BiP Group
Implantation of standard Left Ventricular (LV) lead |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
- Patients age is 18 years or greater
- Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
- Patients must be willing and able to comply with all study requirements
Exclusion Criteria:
- Patients with a life expectancy <12 months.
- Patients who are or may potentially be pregnant.
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Patient has suffered any of the following in the 4 weeks prior to enrolment:
- Myocardial Infarction (MI)
- Coronary Artery Bypass Graft (CABG)
- Unstable Angina Pectoris
- Patient has primary valvular disease which has not been corrected
Information from the National Library of Medicine
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
Locations
Show 64 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
| Principal Investigator: | Giuseppe Boriani, Pro. | Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT01510652 |
| Other Study ID Numbers: |
CR-11-006-HF-ID |
| First Posted: | January 16, 2012 Key Record Dates |
| Results First Posted: | October 23, 2015 |
| Last Update Posted: | February 15, 2019 |
| Last Verified: | January 2019 |
Keywords provided by Abbott Medical Devices:
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Cardiac Resynchronization therapy, Heart Failure, Left Ventricular Lead, |
Quadripolar Left ventricular Lead, Phrenic Nerve Stimulation, Intra and post operative related complications |
Additional relevant MeSH terms:
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Heart Failure Postoperative Complications Heart Diseases Cardiovascular Diseases Pathologic Processes |