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CompletedNCT00187200Updated Feb 5, 2019Results posted

Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients

A Phase 4 interventional study of Simultaneous VV Pacing and Sequential VV Pacing in Heart Failure, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by Abbott Medical Devices · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
816
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.

For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

  • \< 10% improvement in 6-minute hall walk, and
  • no class improvement or worsening in New York Heart Association (NYHA) scale.

For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

  • > 1 heart failure (HF) related hospitalization, and
  • no class improvement or worsening in NYHA scale.
Read the detailed description

Study Methods

  • This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs. sequential BiV pacing) study.
  • Any patient that receives an FDA approved St. Jude Medical (SJM) CRT-D with V-V timing is eligible for enrollment.
  • At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.

  • Patients are followed for a period of 6 months post randomization:

    • Enrollment (1 week pre CRT-D implant to \< 2 weeks post CRT-D implant)
    • Screening/Randomization Visit (3 months post enrollment)
    • Follow-up Visit (6 months post randomization)
  • Total # of centers - 80 centers
  • Sample size - 800 patients screened for CRT non-responders
02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 816 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has a standard indication for a CRT-D.
  • Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
  • Patient is geographically stable and willing to comply with the required follow-up schedule.
  • Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.

  • Patients requiring a CRT-D replacement must comply with BOTH of the following:

    • > 1 HF related hospitalization
    • No class improvement or worsening in NYHA scale

Exclusion criteria

Exclusion Criteria:

  • Patient's life expectancy is less than 12 months.
  • Patient has had cardiac surgery within 6 months of enrollment.
  • Patient has an epicardial ventricular lead system.
  • Patient is less than 18 years old.
  • Patient is pregnant.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
816 participants (actual)

Study arms

  • Active comparator
    Simultaneous VV Pacing

    Programmed to simultaneous biventricular pacing

    Device: Simultaneous VV Pacing

  • Active comparator
    Sequential VV Pacing

    Programmed to sequential biventricular pacing

    Device: Sequential VV Pacing

Interventions

  • DeviceSimultaneous VV Pacing

    Right ventricular and left ventricular pacing delivered simultaneously.

  • DeviceSequential VV Pacing

    Right ventricular and left ventricular pacing delivered sequentially.

06

What researchers measure

Primary outcomes

  1. CRT Responder Rate

    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.

    Time frame: 6 months

Secondary outcomes

  1. NYHA Class Progression

    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.

    Time frame: 6 months

  2. 6 Minute Hall Walk Distance Test (6-MHWD)

    Patients 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.

    Time frame: 6 months

  3. Left Ventricular Ejection Fraction (LVEF)

    Ejection 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).

    Time frame: Randomization and 9 months

07

Results

Posted Sep 25, 2015
Limitations and caveats
Due to the lower than expected non-responder rate at 3 months, the study did not reach the target randomized sample size.

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.

Participant flow — Overall Study
MilestoneSimultaneous Pacing V-V TimingSequential VV Pacing
Started4944
Completed3126
Not completed1818

Outcome measures

PrimaryCRT Responder Rate

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.

Time frame:
6 months
Reported as:
Number · participants
CRT Responder Rate
participantsSimultaneous Pacing V-V TimingSequential VV Pacing
Responders1620
Non-Responders176
SecondaryNYHA Class Progression

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.

Time frame:
6 months
Reported as:
Number · participants
NYHA Class Progression
participantsSimultaneous Pacing V-V TimingSequential VV Pacing
NYYHA Class Improved by 1 category1117
NYHA Class Improved by more than 1 category11
NYHA Class Unchanged177
NYHA Class Worsened11
Secondary6 Minute Hall Walk Distance Test (6-MHWD)

Patients 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.

Time frame:
6 months
Reported as:
Number · participants
6 Minute Hall Walk Distance Test (6-MHWD)
participantsSimultaneous Pacing V-V TimingSequential VV Pacing
Responder1013
Non-Responder2013
SecondaryLeft Ventricular Ejection Fraction (LVEF)

Ejection 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).

Time frame:
Randomization and 9 months
Reported as:
Mean · percentage
Left Ventricular Ejection Fraction (LVEF)
percentageSimultaneous Pacing V-V TimingSequential VV Pacing
Randomization30.6 ± 10.530.7 ± 10.5
9 Month Follow-up Visit32.6 ± 11.832.1 ± 11.6

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Simultaneous Pacing V-V Timing—8/31 (25.8%)7/31 (22.6%)
Sequential VV Pacing—2/26 (7.7%)12/26 (46.2%)
Most frequent serious events
Most frequent serious events
EventSimultaneous Pacing V-V TimingSequential VV Pacing
LEFT BRAIN TIANervous system disorders0/311/26
BACTEREMIAInfections and infestations0/311/26
ONSET OF ATRIAL FIBRILLATIONCardiac disorders1/310/26
RV Lead Dislodgment or MigrationCardiac disorders1/310/26
RV Elevated Pacing ThresholdsCardiac disorders1/310/26
RV Decreased R/P-Wave Amplitude/Loss of SensingCardiac disorders1/310/26
LV Loss of captureCardiac disorders1/310/26
Therapy/Aborted Therapy for Non-Ventricular Rhythm:AF/AFLCardiac disorders1/310/26
MULTIPLE ICD FIRING, NSTEMICardiac disorders1/310/26
CHEST PAIN AND AICD FIRINGCardiac disorders1/310/26
Most frequent other events
Showing 10 of 19
Most frequent other events
EventSimultaneous Pacing V-V TimingSequential VV Pacing
CHF EXACERBATIONCardiac disorders0/311/26
CHF EXACERBATION + NEAR SYNCOPECardiac disorders0/311/26
SHORTNESS OF BREATHCardiac disorders0/311/26
HOSPITALIZATION FOR WEAKNESS WITH ICD FIRING X 2Cardiac disorders0/311/26
PNEUMONIA AND WORSENING KIDNEY FUNCTIONRenal and urinary disorders0/311/26
END STAGE RENAL DZ - (WORSENING OF KNOWN DISEASE)Renal and urinary disorders0/311/26
MRSA INFECTED LEFT ARM DIALYSIS GRAFTInfections and infestations0/311/26
HOSPITALIZATION FOR NEAR SYNCOPECardiac disorders0/311/26
ANEMIABlood and lymphatic system disorders0/311/26
ACUTE VIRAL PERICARDITISCardiac disorders0/311/26

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Simultaneous Pacing V-V TimingSequential VV PacingTotal
<=18 years000
Between 18 and 65 years131528
>=65 years181129
Age, Continuous
Age, Continuous(years)Simultaneous Pacing V-V TimingSequential VV PacingTotal
Mean68.2 ± 8.062.4 ± 11.265.6 ± 10.7
Sex: Female, Male
Sex: Female, Male(Participants)Simultaneous Pacing V-V TimingSequential VV PacingTotal
Female9514
Male222143
Region of Enrollment
Region of Enrollment(participants)Simultaneous Pacing V-V TimingSequential VV PacingTotal
United States312657
08

Study locations

1 site
  • Ohio State University
    Columbus, Ohio 43210, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00187200
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Jan 2005
Primary completion
Apr 2010
Completion
Apr 2010
Results posted
Sep 25, 2015
Last update
Feb 5, 2019

Study contacts

Raul Weiss, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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