Trial Outcomes & Findings for More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges (NCT NCT01510652)
NCT ID: NCT01510652
Last Updated: 2019-02-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1078 participants
Primary outcome timeframe
6 months
Results posted on
2019-02-15
Participant Flow
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
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
719
|
355
|
|
Overall Study
Baseline
|
718
|
348
|
|
Overall Study
COMPLETED
|
627
|
288
|
|
Overall Study
NOT COMPLETED
|
92
|
67
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
Baseline characteristics by cohort
| Measure |
Quad Group
n=718 Participants
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
n=348 Participants
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
n=1066 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
545 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
819 Participants
n=5 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
27.1 %
STANDARD_DEVIATION 7.6 • n=5 Participants
|
27.5 %
STANDARD_DEVIATION 8.1 • n=7 Participants
|
27.2 %
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Left Ventricular End-Diastolic Volume (LVEDV)
|
200.4 ml
STANDARD_DEVIATION 74.9 • n=5 Participants
|
204.5 ml
STANDARD_DEVIATION 72.0 • n=7 Participants
|
203.2 ml
STANDARD_DEVIATION 80.6 • n=5 Participants
|
|
Left Ventricular End-Systolic Volume (LVESV)
|
151.2 ml
STANDARD_DEVIATION 64.0 • n=5 Participants
|
149.0 ml
STANDARD_DEVIATION 58.3 • n=7 Participants
|
150.5 ml
STANDARD_DEVIATION 62.2 • n=5 Participants
|
|
QRS duration
|
158 ms
STANDARD_DEVIATION 29 • n=5 Participants
|
157 ms
STANDARD_DEVIATION 27 • n=7 Participants
|
157.5 ms
STANDARD_DEVIATION 28.4 • n=5 Participants
|
|
Cardiomyopathy
Ischemic
|
353 participants
n=5 Participants
|
196 participants
n=7 Participants
|
549 participants
n=5 Participants
|
|
Cardiomyopathy
Non Ischemic
|
365 participants
n=5 Participants
|
152 participants
n=7 Participants
|
517 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Atrial Fibrillation
|
114 participants
n=5 Participants
|
58 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Atrial Flutter
|
21 participants
n=5 Participants
|
7 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Atrial Arrhythmia History
None
|
583 participants
n=5 Participants
|
283 participants
n=7 Participants
|
866 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage 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.
Outcome measures
| Measure |
Quad Group
n=719 Participants
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
n=355 Participants
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
|
|---|---|---|
|
Lead Performance
|
83 % of patients with freedom from event
|
74.4 % of patients with freedom from event
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 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)
Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
Outcome measures
| Measure |
Quad Group
n=476 Participants
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
n=218 Participants
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
|
|---|---|---|
|
Percentage of Cardiac Resynchronization Therapy Responders
|
62.0 % of patients that are CRT responders
|
56.0 % of patients that are CRT responders
|
SECONDARY outcome
Timeframe: Total duration of the implant procedure reported at the end of the procedurePopulation: The number of participants analyzed is the number of patients with implant data duration time available.
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.
Outcome measures
| Measure |
Quad Group
n=710 Participants
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
n=342 Participants
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
|
|---|---|---|
|
Implant Duration
|
100.4 min
Standard Deviation 54.5
|
101.1 min
Standard Deviation 51
|
Adverse Events
Quad Group
Serious events: 332 serious events
Other events: 186 other events
Deaths: 0 deaths
BiP Group
Serious events: 211 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quad Group
n=719 participants at risk
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
n=355 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
7.4%
53/719 • Number of events 55 • 6 Months: From the enrollment to 6 Months Follow Up
|
9.9%
35/355 • Number of events 35 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Bleeding
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.28%
2/719 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
1.4%
5/355 • Number of events 5 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Heart Failure
|
5.7%
41/719 • Number of events 55 • 6 Months: From the enrollment to 6 Months Follow Up
|
6.8%
24/355 • Number of events 30 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Hematoma
|
2.2%
16/719 • Number of events 16 • 6 Months: From the enrollment to 6 Months Follow Up
|
2.5%
9/355 • Number of events 9 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Infections and infestations
Infection
|
3.3%
24/719 • Number of events 24 • 6 Months: From the enrollment to 6 Months Follow Up
|
6.2%
22/355 • Number of events 22 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Dislodgement (LV Lead)
|
5.1%
37/719 • Number of events 37 • 6 Months: From the enrollment to 6 Months Follow Up
|
5.6%
20/355 • Number of events 22 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Fracture (LV Lead)
|
0.00%
0/719 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Myocardial Infarction
|
0.56%
4/719 • Number of events 4 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.56%
2/355 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Pericarditis
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Phrenic Nerve Stimulation
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.97%
7/719 • Number of events 7 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.56%
2/355 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.70%
5/719 • Number of events 6 • 6 Months: From the enrollment to 6 Months Follow Up
|
2.3%
8/355 • Number of events 8 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
General disorders
Other - Non Cardiac
|
11.3%
81/719 • Number of events 83 • 6 Months: From the enrollment to 6 Months Follow Up
|
13.5%
48/355 • Number of events 51 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Other - Cardiac
|
2.8%
20/719 • Number of events 21 • 6 Months: From the enrollment to 6 Months Follow Up
|
2.5%
9/355 • Number of events 9 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Cardiac Perforation (RV Lead)
|
0.42%
3/719 • Number of events 3 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.56%
2/355 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Cardiac Tamponade
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Coronary Sinus Dissection (LV Lead related)
|
0.00%
0/719 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
General disorders
Death for Unknown Causes
|
0.70%
5/719 • Number of events 5 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.85%
3/355 • Number of events 3 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Skin and subcutaneous tissue disorders
Pocket Erosion
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Pericardial Effusion
|
0.28%
2/719 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.56%
2/355 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/719 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Coronary Sinus Dissection (Other Device related)
|
0.00%
0/719 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.56%
2/355 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Dislodgement (RA Lead)
|
0.97%
7/719 • Number of events 9 • 6 Months: From the enrollment to 6 Months Follow Up
|
1.4%
5/355 • Number of events 5 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Dislodgement (RV Lead)
|
2.1%
15/719 • Number of events 15 • 6 Months: From the enrollment to 6 Months Follow Up
|
1.4%
5/355 • Number of events 5 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Fracture (RV Lead)
|
0.14%
1/719 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Malfunction (RA Lead)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Unstable Position (LV Lead)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Loss of Capture (RV Lead)
|
0.28%
2/719 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
Other adverse events
| Measure |
Quad Group
n=719 participants at risk
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
n=355 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
3.9%
28/719 • Number of events 29 • 6 Months: From the enrollment to 6 Months Follow Up
|
2.3%
8/355 • Number of events 9 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.97%
7/719 • Number of events 7 • 6 Months: From the enrollment to 6 Months Follow Up
|
1.1%
4/355 • Number of events 6 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Heart Failure
|
1.1%
8/719 • Number of events 8 • 6 Months: From the enrollment to 6 Months Follow Up
|
2.8%
10/355 • Number of events 10 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Hematoma
|
3.5%
25/719 • Number of events 25 • 6 Months: From the enrollment to 6 Months Follow Up
|
1.7%
6/355 • Number of events 8 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Infections and infestations
Infection
|
0.83%
6/719 • Number of events 6 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.56%
2/355 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Damaged during Implant
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Dislodgement (LV Lead)
|
0.97%
7/719 • Number of events 7 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.85%
3/355 • Number of events 3 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Phrenic Nerve stimulation
|
3.5%
25/719 • Number of events 26 • 6 Months: From the enrollment to 6 Months Follow Up
|
3.1%
11/355 • Number of events 14 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
General disorders
Other - Non Cardiac
|
5.8%
42/719 • Number of events 43 • 6 Months: From the enrollment to 6 Months Follow Up
|
4.5%
16/355 • Number of events 16 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Cardiac Perforation (Other Device Related)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Other - Cardiac
|
2.6%
19/719 • Number of events 24 • 6 Months: From the enrollment to 6 Months Follow Up
|
3.4%
12/355 • Number of events 12 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Injury, poisoning and procedural complications
Coronary Sinus Dissection (LV Lead Related)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Cardiac disorders
Pericardial Effusion
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Coronary Sinus Dissection (Other Device Related)
|
0.83%
6/719 • Number of events 6 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.56%
2/355 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
High Voltage Lead Impedance (RV Lead)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Lead Dislodgement (RA Lead)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.28%
1/355 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Loss Of Capture (LV Lead)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Oversensing (RV Lead)
|
0.28%
2/719 • Number of events 2 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Pacing Impedance Out Of Range (LV Lead)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
|
Surgical and medical procedures
Pacing Impedance Out Of Range (RV Lead)
|
0.14%
1/719 • Number of events 1 • 6 Months: From the enrollment to 6 Months Follow Up
|
0.00%
0/355 • 6 Months: From the enrollment to 6 Months Follow Up
|
Additional Information
Prof. Giuseppe Boriani
Institute of Cardiology, Univ. of Bologna, Bologna, Italy
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60