More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges (MORE-CRT)
This study is currently recruiting participants.
Verified August 2012 by St. Jude Medical
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01510652
First received: November 30, 2011
Last updated: August 20, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Postoperative Cardiac Complication Heart Failure, Left Ventricular Cardiac Dysfunction Inappropriate Phrenic Nerve Stimulation Perioperative/Postoperative Complications |
Procedure: Standard Left Ventricular (LV) lead Device: Quartet Left Ventricular (LV) lead |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Lead performance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]measures the intra-procedural and post-procedural performance of St. Jude Medical Left Ventricular (SJM LV) quadripolar Quartet lead compared to any other standard bipolar Left Ventricular (LV) lead
Secondary Outcome Measures:
- Percentage of Cardiac Resynchronization Therapy responders [ Time Frame: 6 months ] [ Designated as safety issue: No ]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: Until completion of implantation procedure ] [ Designated as safety issue: No ]The total implant procedure duration time will be compared between the control and the treatment group.
| Estimated Enrollment: | 1062 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Study Group
Patients in the Study group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
|
Device: Quartet Left Ventricular (LV) lead
Implantation of quadripolar Left ventricular (LV) lead Quartet
|
|
Active Comparator: Control Group
Patients in the Control 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: Standard Left Ventricular (LV) lead
Implantation of standard Left Ventricular (LV) lead
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510652
Contacts
| Contact: Giuseppe Boriani, Prof. | giuseppe.boriani@unibo.it |
Locations
| Belgium | |
| Hopital La Citadelle | Not yet recruiting |
| Liège, Belgium | |
| Contact: Jean Borland, Dr. | |
| Principal Investigator: Jean Borland, Dr. | |
| Germany | |
| Klinikum Ludenscheid | Recruiting |
| Ludenscheid, Germany | |
| Contact: Bernd Lemke, Prof. | |
| Principal Investigator: Bernd Lemke, Prof. | |
| Ireland | |
| Beaumont Hospital | Not yet recruiting |
| Dublin, Ireland | |
| Contact: Ricky Sheahan, Dr. | |
| Principal Investigator: Ricky Sheahan, Dr. | |
| Italy | |
| Policlinico S. Orsola & Malpighi | Not yet recruiting |
| Bologna, Italy | |
| Contact: Giuseppe Boriani, Prof. +390516363598 giuseppe.boriani@unibo.it | |
| Principal Investigator: Giuseppe Boriani, Prof. | |
| Ospedale SS. Annunziata | Not yet recruiting |
| Taranto, Italy | |
| Contact: Vitantonio Russo, Prof. | |
| Principal Investigator: Vitantonio Russo, Prof. | |
| Netherlands | |
| MC Haaglanden | Recruiting |
| Den Haag, Netherlands | |
| Contact: Alexander Wardeh, Dr. a.wardeh@mchaaglanden.nl | |
| Principal Investigator: Alexander Wardeh, Dr. | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | Giuseppe Boriani, Pro. | Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy |
More Information
No publications provided
| 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 |
| Last Updated: | August 20, 2012 |
| Health Authority: | Belgium: Ethics Committee Germany: Ethics Commission Italy: Ethics Committee Netherlands: Independent Ethics Committee |
Keywords provided by St. Jude Medical:
|
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:
|
Heart Failure Postoperative Complications Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013