Trial Outcomes & Findings for Quartet Lead and Resynchronization Therapy Options (NCT NCT01295840)

NCT ID: NCT01295840

Last Updated: 2019-02-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: Enrollment visit (in the seven days after implantation of the device)
• Results posted on: 2019-02-20

Participant Flow

The recruitment target is approximately 50 patients. Recruitment will be competitive, and will last for approximately 12 months, plus six months of follow-up. The trial will finish once all the patients have completed the follow-up.

Participant milestones

Measure	No Arms All patient have a Quartet Left Ventricular (LV) lead. No arms.
Overall Study STARTED	51
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quartet Lead and Resynchronization Therapy Options

Baseline characteristics by cohort

Measure	No Arms n=51 Participants All patient have a Quartet LV lead. No arms.
Age, Continuous	65.4 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment visit (in the seven days after implantation of the device)

Outcome measures

Measure	No Arms n=51 Participants All patient have a Quartet LV lead. No arms.
Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.	27 participants

SECONDARY outcome

Timeframe: At enrollment

In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors.

The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC.

Outcome measures

Measure	No Arms n=51 Participants All patient have a Quartet LV lead. No arms.
Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors	11.69 percentage of difference of CO Standard Deviation 11.12

SECONDARY outcome

Timeframe: Enrollment visit (in the seven days after implantation of the device)

Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.

Outcome measures

Measure	No Arms n=51 Participants All patient have a Quartet LV lead. No arms.
Cardiac Output (CO) With Different Configurations at Enrollment Non-paced CO	3.64 L/min Standard Deviation 0.94
Cardiac Output (CO) With Different Configurations at Enrollment Best CO with Traditional vectors	4.16 L/min Standard Deviation 1.12
Cardiac Output (CO) With Different Configurations at Enrollment Best CO with All vectors available in Quartet lead	4.33 L/min Standard Deviation 1.12

SECONDARY outcome

Timeframe: Enrollment visit (in the seven days after implantation of the device)

Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

Outcome measures

Measure	No Arms n=51 Participants All patient have a Quartet LV lead. No arms.
Capture Threshold Best Capture Threshold for Traditional vectors	0.79 volts Standard Deviation 0.47
Capture Threshold Best Capture Threshold for Non-Traditional vectors	0.97 volts Standard Deviation 0.55
Capture Threshold Best Capture Threshold for all vectors	0.72 volts Standard Deviation 0.32

SECONDARY outcome

Timeframe: 6 months post-implant

Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

Outcome measures

Measure	No Arms n=50 Participants All patient have a Quartet LV lead. No arms.
Capture Threshold Best Capture Threshold for Traditional vectors	0.96 volts Standard Deviation 0.54
Capture Threshold Best Capture Threshold for Non-Traditional vectors	1.21 volts Standard Deviation 0.47
Capture Threshold Best Capture Threshold for all vectors	0.90 volts Standard Deviation 0.41

SECONDARY outcome

Timeframe: Enrollment visit (in the seven days after implantation of the device)

Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

Outcome measures

Measure	No Arms n=510 Number of total vectors All patient have a Quartet LV lead. No arms.
Number of Vectors With Phrenic Nerve Stimulation (PNS) Number of Traditional vectors with PNS	51 number of vectors
Number of Vectors With Phrenic Nerve Stimulation (PNS) Number of Non-Traditional vectors with PNS	69 number of vectors
Number of Vectors With Phrenic Nerve Stimulation (PNS) Number of Total vectors with PNS	120 number of vectors

SECONDARY outcome

Timeframe: At 6 months

Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

Outcome measures

Measure	No Arms n=510 Number of vectors All patient have a Quartet LV lead. No arms.
Number of Vectors With Phrenic Nerve Stimulation (PNS) Number of Traditional vectors with PNS	49 number of vectors
Number of Vectors With Phrenic Nerve Stimulation (PNS) Number of Non-Traditional vectors with PNS	69 number of vectors
Number of Vectors With Phrenic Nerve Stimulation (PNS) Number of Total vectors with PNS	118 number of vectors

SECONDARY outcome

Timeframe: At enrollment

To calculate the number of patients that exhibit PNS in all traditional vector

Outcome measures

Measure	No Arms n=51 Participants All patient have a Quartet LV lead. No arms.
Number of Patients With PNS in All Vectors	8 participants

SECONDARY outcome

Timeframe: At enrollment

To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector

Outcome measures

Measure	No Arms n=51 Participants All patient have a Quartet LV lead. No arms.
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector	7 participants

SECONDARY outcome

Timeframe: At 6 months

To calculate the number of patients that exhibit PNS in all traditional vector

Outcome measures

Measure	No Arms n=50 Participants All patient have a Quartet LV lead. No arms.
Number of Patients With PNS in All Vectors	7 participants

SECONDARY outcome

Timeframe: At 6 months

To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector

Outcome measures

Measure	No Arms n=50 Participants All patient have a Quartet LV lead. No arms.
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector	5 participants

Adverse Events

No Arms

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Arms n=51 participants at risk All patient have a Quartet LV lead. No arms
Surgical and medical procedures RV lead dislodgment	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Dyspnea, angina pectoris, severe LV dysfunction, stent implantation	2.0% 1/51 • Number of events 1 • 6 months period
Respiratory, thoracic and mediastinal disorders Pneumothorax, lung was needled during implantation	2.0% 1/51 • Number of events 1 • 6 months period
Surgical and medical procedures LV lead dislocation	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Atrial fibrillation	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Dyspnea due to renal failure, pulmonary edema, flutter	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Congestive cardiac insufficiency	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Renal insufficiency, cardiogenic shock and flutter	2.0% 1/51 • Number of events 1 • 6 months period
Infections and infestations Fever, infection	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Fatigue, hypotension episode	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Atrial fibrillation, cardiovertion	2.0% 1/51 • Number of events 1 • 6 months period
Cardiac disorders Dyspnea, acute lung edema after ICD explant and CRT implant Hypoxemia, COPD worsening renal failure	2.0% 1/51 • Number of events 1 • 6 months period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cognitive impairment, disorientation, injury from tumoral origin	2.0% 1/51 • Number of events 1 • 6 months period
Renal and urinary disorders Renal function worsening	2.0% 1/51 • Number of events 1 • 6 months period
Surgical and medical procedures Pain at the pocket of device	2.0% 1/51 • Number of events 1 • 6 months period

Other adverse events

Adverse event data not reported

Additional Information

Dr Javier Alzueta

Hospital Universitario Virgen de la Victoria

Phone: +34 952 64 15 50

Email: jalzueta@telefonica.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60