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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quad Group | Active Comparator | Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet |
|
| BiP Group | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiP Group | Procedure | Implantation of standard Left Ventricular (LV) lead |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lead Performance | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Cardiac Resynchronization Therapy Responders | Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV) | Baseline and 6 months |
| Implant Duration |
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Inclusion Criteria:
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:
Patient has primary valvular disease which has not been corrected
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Boriani, Pro. | Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Belgium | ||||
| Hopital La Citadelle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29766873 | Derived | Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | BiP Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Quad Group |
| Device |
Implantation of quadripolar Left ventricular (LV) lead Quartet |
|
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.
| Total duration of the implant procedure reported at the end of the procedure |
| Liège |
| Belgium |
| Foothills Medical Center | Calgary | Canada |
| Royal Alexandra Hospital | Edmonton | Canada |
| QE II Health Sciences | Halifax | Canada |
| Institut de Cardiologie du Quebec - Hopital Laval | Québec | Canada |
| HSC Heastern Health | St. Johns | Canada |
| Paijat-Hame Central Hospital | Lahti | Finland |
| Tampere University Hospital | Tampere | Finland |
| CHU La Cavale Blanche | Brest | France |
| CHU Gabriel Montpied | Clermont-Ferrand | France |
| CHRU Hopital Albert Michallon | Grenoble | France |
| Hopital Cardiovasculaire et Pneumologique Louis Pradel | Lyon | France |
| Hopital de la Timone | Marseille | France |
| Hopital du Nord - CH Bourrely St. Antoine | Marseille | France |
| CHU Hopital G&R Laennec | Nantes | France |
| Nouvelles Cliniques Nantaises | Nantes | France |
| CHRU Hopital de Pontchaillou | Rennes | France |
| CHRU Hopital Charles Nicolle | Rouen | France |
| CHU St. Etienne | Saint-Priest-en-Jarez | France |
| Clinique du Tonkin | Villeurbanne | France |
| Charite Campus Virchow Klinikum | Berlin | Germany |
| Unfallkrankenhaus Berlin-Marzahn | Berlin | Germany |
| Stadtische Kliniken Bielefeld | Bielefeld | Germany |
| Klinikum Coburg | Coburg | Germany |
| Elisabeth-Krankenhaus | Essen | Germany |
| Universitatsklinikum Greifswald | Greifswald | Germany |
| Universitatskliniken des Saarlandes | Homburg | Germany |
| Universitatsklinikum Leipzig | Leipzig | Germany |
| Stadtisches Klinikum Ludwigshafen | Ludwigshafen | Germany |
| Klinikum Ludenscheid | Lüdenscheid | Germany |
| Krankenhaus der Barmherzigen | Trier | Germany |
| All India Institute of Medical Sciences | New Delhi | India |
| Escorts Heart Institute and Research Center | New Delhi | India |
| Barzilai Medical Center | Ashkelon | Israel |
| Soroka University Hospital | Beersheba | Israel |
| Kaplan Medical Center | Rehovot | Israel |
| Sheba Medical Center | Tel Litwinsky | Israel |
| Policlinico S. Orsola & Malpighi | Bologna | Italy |
| Azienda Ospedaliera S.Anna e S.Sebastiano | Caserta | Italy |
| Azienda Ospedaliera Mater Domini | Catanzaro | Italy |
| Ospedale Vito Fazzi | Lecce | Italy |
| Ospedale Maggiore della Carità | Novara | Italy |
| Policlinico Casilino | Rome | Italy |
| Ospedale SS. Annunziata | Taranto | Italy |
| Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista | Torino | Italy |
| Ospedale Civile Maggiore Verona Borgo Trento | Verona | Italy |
| Amphia Hospital | Breda | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Haga Ziekenhuis | The Hague | Netherlands |
| MC Haaglanden | The Hague | Netherlands |
| Slaskie Centrum Chorob Serca | Zabrze | Poland |
| Hospital de Basurto | Bilbao | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| Hospital Universitari La Fe | Valencia | Spain |
| Basel University Hospital | Basel | Switzerland |
| Hopital Cantonal Universitaire de Geneva | Geneva | Switzerland |
| Fondazione Cardiocentro Ticino | Lugano | Switzerland |
| Universitaets Spital Zuerich | Zurich | Switzerland |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| University Hospital of Wales | Cardiff | United Kingdom |
| St. Thomas Hospital | London | United Kingdom |
| James Cook University Hospital | Middlesbrough | United Kingdom |
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 |
| Baseline |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Left Ventricular Ejection Fraction (LVEF) | Mean | Standard Deviation | % |
| |||||||||||||||
| Left Ventricular End-Diastolic Volume (LVEDV) | Mean | Standard Deviation | ml |
| |||||||||||||||
| Left Ventricular End-Systolic Volume (LVESV) | Mean | Standard Deviation | ml |
| |||||||||||||||
| QRS duration | Mean | Standard Deviation | ms |
| |||||||||||||||
| Cardiomyopathy | Number | participants |
| ||||||||||||||||
| Atrial Arrhythmia History | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lead Performance | 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. | Posted | Number | % of patients with freedom from event | 6 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Cardiac Resynchronization Therapy Responders | Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV) | The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable) | Posted | Number | % of patients that are CRT responders | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Implant Duration | 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. | The number of participants analyzed is the number of patients with implant data duration time available. | Posted | Mean | Standard Deviation | min | Total duration of the implant procedure reported at the end of the procedure |
|
|
6 Months: From the enrollment to 6 Months Follow Up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 332 | 719 | 186 | 719 | ||
| EG001 | 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 | 211 | 355 | 76 | 355 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Lead Dislodgement (LV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Lead Fracture (LV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Phrenic Nerve Stimulation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Other - Non Cardiac | General disorders | Systematic Assessment |
| ||
| Other - Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Perforation (RV Lead) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Coronary Sinus Dissection (LV Lead related) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Death for Unknown Causes | General disorders | Systematic Assessment |
| ||
| Pocket Erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Coronary Sinus Dissection (Other Device related) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lead Dislodgement (RA Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Lead Dislodgement (RV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Lead Fracture (RV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Lead Malfunction (RA Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Lead Unstable Position (LV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Loss of Capture (RV Lead) | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Lead Damaged during Implant | Surgical and medical procedures | Systematic Assessment |
| ||
| Lead Dislodgement (LV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Phrenic Nerve stimulation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Other - Non Cardiac | General disorders | Systematic Assessment |
| ||
| Cardiac Perforation (Other Device Related) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other - Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Sinus Dissection (LV Lead Related) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Coronary Sinus Dissection (Other Device Related) | Surgical and medical procedures | Systematic Assessment |
| ||
| High Voltage Lead Impedance (RV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Lead Dislodgement (RA Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Loss Of Capture (LV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Oversensing (RV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Pacing Impedance Out Of Range (LV Lead) | Surgical and medical procedures | Systematic Assessment |
| ||
| Pacing Impedance Out Of Range (RV Lead) | Surgical and medical procedures | Systematic Assessment |
|
Patients were followed for only 6 months, studies with longer follow-up would add to the body of evidence.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Giuseppe Boriani | Institute of Cardiology, Univ. of Bologna, Bologna, Italy | giuseppe.boriani@unibo.it |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Non Ischemic |
|
| Atrial Flutter |
|
| None |
|
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|
|