Trial Outcomes & Findings for Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients (NCT NCT00187200)
NCT ID: NCT00187200
Last Updated: 2019-02-05
Results Overview
Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.
COMPLETED
PHASE4
816 participants
6 months
2019-02-05
Participant Flow
816 patients were enrolled in the trial. Of the patients screened at the 3-month follow up, 572 patients were classified as responders and 102 patients as non-responders.
102 of the patients were non-responders, but only 93 were randomized of which 57 completed the study and had data available for analysis. of the 816 participants screened only 93 wre randomized to treatment. This statement is accurate and appropriate.
Participant milestones
| Measure |
Simultaneous Pacing V-V Timing
Patients maintained on simultaneous V-V delay
|
Sequential VV Pacing
V-V delay was optimized
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
44
|
|
Overall Study
COMPLETED
|
31
|
26
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
Baseline characteristics by cohort
| Measure |
Simultaneous Pacing V-V Timing
n=31 Participants
Patients maintained on simultaneous V-V delay
|
Sequential VV Pacing
n=26 Participants
V-V delay was optimized
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
26 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per protocol analysis.
Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.
Outcome measures
| Measure |
Simultaneous Pacing V-V Timing
n=33 Participants
Patients maintained on simultaneous V-V delay per protocol
|
Sequential VV Pacing
n=26 Participants
V-V delay was optimized per protocol
|
|---|---|---|
|
CRT Responder Rate
Responders
|
16 participants
|
20 participants
|
|
CRT Responder Rate
Non-Responders
|
17 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol analysis
New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.
Outcome measures
| Measure |
Simultaneous Pacing V-V Timing
n=30 Participants
Patients maintained on simultaneous V-V delay per protocol
|
Sequential VV Pacing
n=26 Participants
V-V delay was optimized per protocol
|
|---|---|---|
|
NYHA Class Progression
NYHA Class Worsened
|
1 participants
|
1 participants
|
|
NYHA Class Progression
NYYHA Class Improved by 1 category
|
11 participants
|
17 participants
|
|
NYHA Class Progression
NYHA Class Improved by more than 1 category
|
1 participants
|
1 participants
|
|
NYHA Class Progression
NYHA Class Unchanged
|
17 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 6 monthsPatients were considered non-responders if the 6-MHWD had not improved by greater than or equal to 10% compared to baseline. This statement is accurate and appropriate.
Outcome measures
| Measure |
Simultaneous Pacing V-V Timing
n=30 Participants
Patients maintained on simultaneous V-V delay per protocol
|
Sequential VV Pacing
n=26 Participants
V-V delay was optimized per protocol
|
|---|---|---|
|
6 Minute Hall Walk Distance Test (6-MHWD)
Responder
|
10 participants
|
13 participants
|
|
6 Minute Hall Walk Distance Test (6-MHWD)
Non-Responder
|
20 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Randomization and 9 monthsEjection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The left ventricle is the heart's main pumping chamber, so ejection fraction is usually measured only in the left ventricle (LV).
Outcome measures
| Measure |
Simultaneous Pacing V-V Timing
n=30 Participants
Patients maintained on simultaneous V-V delay per protocol
|
Sequential VV Pacing
n=26 Participants
V-V delay was optimized per protocol
|
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
Randomization
|
30.6 percentage
Standard Deviation 10.5
|
30.7 percentage
Standard Deviation 10.5
|
|
Left Ventricular Ejection Fraction (LVEF)
9 Month Follow-up Visit
|
32.6 percentage
Standard Deviation 11.8
|
32.1 percentage
Standard Deviation 11.6
|
Adverse Events
Simultaneous Pacing V-V Timing
Sequential VV Pacing
Serious adverse events
| Measure |
Simultaneous Pacing V-V Timing
n=31 participants at risk
Patients maintained on simultaneous V-V delay
|
Sequential VV Pacing
n=26 participants at risk
V-V delay was optimized
|
|---|---|---|
|
Cardiac disorders
ONSET OF ATRIAL FIBRILLATION
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
RV Lead Dislodgment or Migration
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
RV Elevated Pacing Thresholds
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
RV Decreased R/P-Wave Amplitude/Loss of Sensing
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Nervous system disorders
LEFT BRAIN TIA
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
LV Loss of capture
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
BACTEREMIA
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
Therapy/Aborted Therapy for Non-Ventricular Rhythm:AF/AFL
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
MULTIPLE ICD FIRING, NSTEMI
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
CHEST PAIN AND AICD FIRING
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
Other adverse events
| Measure |
Simultaneous Pacing V-V Timing
n=31 participants at risk
Patients maintained on simultaneous V-V delay
|
Sequential VV Pacing
n=26 participants at risk
V-V delay was optimized
|
|---|---|---|
|
Cardiac disorders
DIAPHRAGMATIC CAPTURE BY ATRIAL LEAD
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
CHF EXACERBATION
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
CHF EXACERBATION + NEAR SYNCOPE
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
SHORTNESS OF BREATH
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
NEAR SYNCOPE WITH GENERAL WEAKNESS
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
HOSPITALIZATION FOR WEAKNESS WITH ICD FIRING X 2
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
PNEUMONIA AND WORSENING KIDNEY FUNCTION
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
END STAGE RENAL DZ - (WORSENING OF KNOWN DISEASE)
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
MRSA INFECTED LEFT ARM DIALYSIS GRAFT
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
HOSPITALIZATION FOR NEAR SYNCOPE
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
General disorders
DIZZY SPELL
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
ACUTE VIRAL PERICARDITIS
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
ABDOMINAL AORTIC ANEURYSM
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
SYNCOPE
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
General disorders
SINUS INFECTION
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
COPD (CHRONIC)
|
3.2%
1/31 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
EXACERBATION CONGESTIVE HEART FAILURE
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
WORSENING RENAL FUNCTION
|
0.00%
0/31
|
3.8%
1/26 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications and presentation should be presented to sponsor 30 days (manuscripts) or 7 days (abstracts) prior to submission for publication. The sponsor reserves the right to deny submission of study results if based on data owned by sponsor.
- Publication restrictions are in place
Restriction type: OTHER