Trial Outcomes & Findings for Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial (NCT NCT01059175)

NCT ID: NCT01059175

Last Updated: 2025-07-02

Results Overview

M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	CRT With Dual Site LV Pacing Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Overall Study STARTED	43	41
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	21	20

Reasons for withdrawal

Measure	CRT With Dual Site LV Pacing Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Overall Study Death	17	17
Overall Study Adverse Event	4	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial

Baseline characteristics by cohort

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Total n=83 Participants Total of all reporting groups
Age, Continuous	70.5 years STANDARD_DEVIATION 7.7 • n=5 Participants	72.2 years STANDARD_DEVIATION 7.9 • n=7 Participants	71.3 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Patients with ischemic heart disease	22 participants n=5 Participants	24 participants n=7 Participants	46 participants n=5 Participants
Paced QRS duration	165 milliseconds STANDARD_DEVIATION 30.5 • n=5 Participants	155 milliseconds STANDARD_DEVIATION 42.2 • n=7 Participants	160 milliseconds STANDARD_DEVIATION 36.8 • n=5 Participants
Time from first CRT implant	43.5 months STANDARD_DEVIATION 28.4 • n=5 Participants	37.8 months STANDARD_DEVIATION 23.7 • n=7 Participants	40.6 months STANDARD_DEVIATION 26.2 • n=5 Participants
LVEF % (left ventricle ejection fraction)	26.9 percent STANDARD_DEVIATION 6.0 • n=5 Participants	25.9 percent STANDARD_DEVIATION 7.0 • n=7 Participants	26.4 percent STANDARD_DEVIATION 6.4 • n=5 Participants
LVEDV (left ventricular end-diastolic volume)	219 milliliter STANDARD_DEVIATION 85.8 • n=5 Participants	206 milliliter STANDARD_DEVIATION 63.9 • n=7 Participants	213 milliliter STANDARD_DEVIATION 75.7 • n=5 Participants
LVESV (left ventricular end-systolic volume)	154 milliliter STANDARD_DEVIATION 61.8 • n=5 Participants	149 milliliter STANDARD_DEVIATION 58.7 • n=7 Participants	151 milliliter STANDARD_DEVIATION 59.8 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved.

Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened.

Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.

Unchanged : if none of the previous definition applies.

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=40 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score Improved patients	11 participants	7 participants
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score Unchanged patients	10 participants	16 participants
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score Worsened patients	21 participants	17 participants

SECONDARY outcome

Timeframe: 24 months

Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved.

Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened.

Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.

Unchanged : if none of the previous definition applies.

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=40 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score Patients unchanged	8 participants	12 participants
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score Patients improved	8 participants	3 participants
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score Patients worsened	26 participants	25 participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Rate of Adverse Events Patients with at least one AE	38 participants	34 participants
Rate of Adverse Events Patients with at least one severe AE	33 participants	33 participants

SECONDARY outcome

Timeframe: 24 months

Changes between baseline and 24months follow up

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study	-15.1 meters Standard Deviation 88.0	7.5 meters Standard Deviation 96.3

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study	19 participants	22 participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Time to First Heart Failure Related Hospitalization	357.6 days Standard Error 27.17	402.4 days Standard Error 41.16

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Overall Mortality	17 participants	17 participants

SECONDARY outcome

Timeframe: 24 months

Population: Number of patients with data available for analysis of this objective

Changes between baseline and 24months follow up

Outcome measures

Measure	CRT With Dual Site LV Pacing n=42 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Changes in Echocardiographic Indexes of Left Ventricle Remodeling Changes in LVEDV	-16.4 milliliter Standard Deviation 78.6	7.0 milliliter Standard Deviation 72.1
Changes in Echocardiographic Indexes of Left Ventricle Remodeling Changes in LVESV	-14.3 milliliter Standard Deviation 57.6	-2.0 milliliter Standard Deviation 60.6

SECONDARY outcome

Timeframe: 24 months

Population: Number of patients with data available for analysis of this objective

Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.

Outcome measures

Measure	CRT With Dual Site LV Pacing n=21 Participants Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=21 Participants Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire	-7.33 units on a scale Standard Deviation 23.5	-7.48 units on a scale Standard Deviation 17.2

Adverse Events

CRT With Dual Site LV Pacing

Serious events: 33 serious events

Other events: 38 other events

Deaths: 0 deaths

Standard CRT

Serious events: 33 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	CRT With Dual Site LV Pacing n=42 participants at risk Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 participants at risk Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Cardiac disorders Severe cardiovascular event	78.6% 33/42	80.5% 33/41

Other adverse events

Measure	CRT With Dual Site LV Pacing n=42 participants at risk Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device	Standard CRT n=41 participants at risk Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Cardiac disorders Cardiac AE	90.5% 38/42	82.9% 34/41

Additional Information

Latifa Foudali

Medtronic

Phone: +33 631992144

Email: latifa.foudali@medtronic.com

Results disclosure agreements

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