Heart FailureBIPACSNCT00498940
Biventricular Pacing After Cardiopulmonary Bypass
A study testing Optimization Testing and Temporary Biventricular Pacing in people with Heart Failure, run by Henry M. Spotnitz at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of optimized temporary biventricular pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and an intraventricular conduction delay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Optimization Testing and Temporary Biventricular Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LV ejection fraction < 41%
- QRS duration > 99 msec
- Or:
- Mitral and Aortic Valve Repair or Replacement
Who cannot join
- Congenital Heart Disease
- Intracardiac Shunts
- Preoperative Pacing for Heart Block (2nd or 3rd degree) or Sinus Bradycardia
- Heart Rate > 120 beats per min after Cardiopulmonary Bypass
- Preoperative Atrial Fibrillation
- Previous Cardiac Surgery
- Inability to undergo biventricular pacing prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the efficacy of optimized temporary biventricular pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and an intraventricular conduction delay. This study will compare extended temporary biventricular pacing versus standard of care by assessing patients randomized to the two groups, from the conclusion of cardiopulmonary bypass, until the conclusion of pharmacologic circulatory support in the intensive care unit. In addition, effects of biventricular pacing will be tested in all patients, at three time points, using different measures of blood flow. Results from this research will demonstrate whether temporary BiVP improves cardiac output after open-heart surgery and whether ventricular pacing optimization increases cardiac output in this setting. Success would lead to the development of recommendations for use of BiVP postoperatively and would stimulate the development of pacemakers with appropriate features.
The primary hypothesis is that the optimum pacing protocol (POPT) will increase cardiac index (CI) by 15% (from approximately 2.30 to 2.64 L/min/m2) compared to standard of care as measured by thermodilution 12-24 hours postoperatively. Secondary objectives include defining POPT at three time points within 24 hours of surgery. The investigator will examine which forms of cardiac dysfunction benefit from temporary pacing using direct and indirect measures of perfusion and cardiac function. The investigator will also analyze survival, length of stay, incidence of arrhythmias, and cost of postoperative care.
Read the detailed description
Biventricular pacing (BiVP) reverses intraventricular conduction delay (IVCD) and left ventricular (LV) dysfunction in dilated cardiomyopathy (DCM). BiVP improves LV function and cardiac index (Cl) at no energy cost. In the MIRACLE trial, in patients with DCM, IVCD and LV ejection fraction <35%, demonstrated improved subjective and objective measures of exercise tolerance and cardiac function with BiVP. BiVP benefits many, but selection criteria are not fully developed, and 30% of recipients are "nonresponders," at a cost of more than $2 billion/year. Preliminary data suggest that BiVP can benefit patients with low output states after cardiac surgery. This study will assess surgical application of BiVP while assessing mechanisms of action and optimization. 190 cardiac surgery patients will be randomized with LV dysfunction preoperatively to paced and standard of care groups. BiVP will be optimized and continued postoperatively until patients are stable. BiVP will be assessed transiently in all patients at three time points. The primary end point is a 15% improvement in thermal dilution Cl measured in the intensive care unit (ICU). Effects of heart rate, atrioventricular delay, ventricular pacing site, and interventricular delay on Cl will be assessed using a randomized sequence of data collection. Secondary endpoints include incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality, and ICU costs. These studies are important because of a high probability of clinical benefit. The methods employed will provide precision, breadth of measurement, and range of pacing sites superior to any other setting. The protocol will provide new and important scientific information that will benefit not only surgical patients but also the general population of BiVP recipients.
- Conditions
- Heart Failure
- Being tested
- Optimization Testing, Temporary Biventricular Pacing
- Keywords
- LV function, Compliance, wall motion, echocardiography
- Medical subject headings
- Heart Failure, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization TestingDevice
Also called Medtronic Insync III
Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.
Temporary Biventricular PacingDevice
Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Biventricular Pacing | Active comparator | After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate). Receives: Device: Optimization Testing; Device: Temporary Biventricular Pacing |
| Standard of Care | Active comparator | No continuous pacing occurred about surgery. Patients underwent optimization testing. Receives: Device: Optimization Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).
Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.
Measured: 24 hours
Secondary outcomes (1)
Number of Subjects With Postoperative Complications
This is to measure the total number of subjects that experienced any of the following complications: sepsis/infection, renal failure, respiratory failure/complications, bleeding requiring reoperation, cerebrovascular accident.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startOct 2006
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Accrual too slow; grant renewal unlikely; AAI as effective as BiV in Phase III
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Spotnitz
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Henry M. Spotnitz, Columbia University
- Investigators
- Henry M. Spotnitz, M.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498940
- Sponsor's protocol ID
- AAAB5600
- Other IDs
- R01HL080152
- Acronym
- BIPACS
- Status last verified
- Jan 2018
- First submitted
- 9 Jul 2007
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rubinstein BJ, Wang DY, Cabreriza SE, Cheng B, Aponte-Patel L, Murata A, Rusanov A, Richmond ME, Quinn TA, Spotnitz HM. Response of mean arterial pressure to temporary biventricular pacing after chest closure during cardiac surgery. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1445-52. doi: 10.1016/j.jtcvs.2012.04.026. Epub 2012 Aug 21.
PubMed 22920599
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biventricular Pacing After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00498940
- Acronym / sponsor ID
- BIPACS / AAAB5600
- Conditions
- Heart Failure
- Keywords
- LV function, Compliance, wall motion, echocardiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual too slow; grant renewal unlikely; AAI as effective as BiV in Phase III
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Henry M. SpotnitzUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Posted 2 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of optimized temporary biventricular pacing (BiVP) in patients undergoing open-heart surgery with preoperative LV dysfunction and an intraventricular conduction delay. This study will compare extended temporary biventricular pacing versus standard of care by assessing patients randomized to the two groups, from the conclusion of cardiopulmonary bypass, until the conclusion of pharmacologic circulatory support in the intensive care unit. In addition, effects of biventricular pacing will be tested in all patients, at three time points, using different measures of blood flow. Results from this research will demonstrate whether temporary BiVP improves cardiac output after open-heart surgery and whether ventricular pacing optimization increases cardiac output in this setting. Success would lead to the development of recommendations for use of BiVP postoperatively and would stimulate the development of pacemakers with appropriate features.
The primary hypothesis is that the optimum pacing protocol (POPT) will increase cardiac index (CI) by 15% (from approximately 2.30 to 2.64 L/min/m2) compared to standard of care as measured by thermodilution 12-24 hours postoperatively. Secondary objectives include defining POPT at three time points within 24 hours of surgery. The investigator will examine which forms of cardiac dysfunction benefit from temporary pacing using direct and indirect measures of perfusion and cardiac function. The investigator will also analyze survival, length of stay, incidence of arrhythmias, and cost of postoperative care.
Detailed description
Biventricular pacing (BiVP) reverses intraventricular conduction delay (IVCD) and left ventricular (LV) dysfunction in dilated cardiomyopathy (DCM). BiVP improves LV function and cardiac index (Cl) at no energy cost. In the MIRACLE trial, in patients with DCM, IVCD and LV ejection fraction <35%, demonstrated improved subjective and objective measures of exercise tolerance and cardiac function with BiVP. BiVP benefits many, but selection criteria are not fully developed, and 30% of recipients are "nonresponders," at a cost of more than $2 billion/year. Preliminary data suggest that BiVP can benefit patients with low output states after cardiac surgery. This study will assess surgical application of BiVP while assessing mechanisms of action and optimization. 190 cardiac surgery patients will be randomized with LV dysfunction preoperatively to paced and standard of care groups. BiVP will be optimized and continued postoperatively until patients are stable. BiVP will be assessed transiently in all patients at three time points. The primary end point is a 15% improvement in thermal dilution Cl measured in the intensive care unit (ICU). Effects of heart rate, atrioventricular delay, ventricular pacing site, and interventricular delay on Cl will be assessed using a randomized sequence of data collection. Secondary endpoints include incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality, and ICU costs. These studies are important because of a high probability of clinical benefit. The methods employed will provide precision, breadth of measurement, and range of pacing sites superior to any other setting. The protocol will provide new and important scientific information that will benefit not only surgical patients but also the general population of BiVP recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biventricular Pacing | Active comparator | Device: Optimization Testing, Device: Temporary Biventricular PacingAfter weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate). |
| Standard of Care | Active comparator | Device: Optimization TestingNo continuous pacing occurred about surgery. Patients underwent optimization testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- LV ejection fraction < 41%
- QRS duration > 99 msec
- Mitral and Aortic Valve Repair or Replacement
Key exclusion criteria (7 listed)
- Congenital Heart Disease
- Intracardiac Shunts
- Preoperative Pacing for Heart Block (2nd or 3rd degree) or Sinus Bradycardia
- Heart Rate > 120 beats per min after Cardiopulmonary Bypass
- Preoperative Atrial Fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimization TestingAlso: Medtronic Insync IIIAtrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III. | Device | Biventricular Pacing, Standard of Care |
| Temporary Biventricular PacingContinuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate. | Device | Biventricular Pacing |
Primary outcome
Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).
Time frame: 24 hours
Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.
1 secondary outcome
Number of Subjects With Postoperative Complications
Time frame: 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22920599Rubinstein BJ, Wang DY, Cabreriza SE, Cheng B, Aponte-Patel L, Murata A, Rusanov A, Richmond ME, Quinn TA, Spotnitz HM. Response of mean arterial pressure to temporary biventricular pacing after chest closure during cardiac surgery. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1445-52. doi: 10.1016/j.jtcvs.2012.04.026. Epub 2012 Aug 21.
- ColumbiaDoctors - Clinical Trials Search ToolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry M. Spotnitz, M.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization Testing and Temporary Biventricular Pacing in people with Heart Failure, run by Henry M. Spotnitz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU). (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00498940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.