Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01446796
• Collaborator: Medtronic (Industry)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure. However, little is known about RV pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (LVAD). The univentricular support provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart failure patients, yet the incidence of RV failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing may counteract these adverse mechanical alterations, improving RV systolic function and ultimately LVAD function.

The investigators will recruit all patients referred for an implantable, continuous flow LVAD at Duke University Medical Center who have an existing implantable dual-chamber cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. Multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, RV function by Echocardiography as well as patient symptoms and functional status.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD); Device: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Hemodynamic and Clinical Effects of Continuous Right Ventricular Pacing in the Early Post-operative Period After Left Ventricular Assist Device Implantation
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Native Conduction Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.	Device: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD); Pacing parameters set to AAI 90
Experimental: Continuous RV Pacing Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats	Device: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD); Pacing parameters set to DDD 90-100

Outcome Measures

Primary Outcome Measures

1. Length of Hospitalization [14 days]

   To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.

Secondary Outcome Measures

1. Post-operative Need for Hemodynamic / Respiratory Support [14 days]

   To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.

2. Right Ventricular Function [14 days]

   To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.

3. Functional Capacity and Symptoms [14 days]

   To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years old, both men and women

• Existing implantable cardioverter-defibrillator (ICD)

• Referred for implantation of a continuous flow LVAD

Exclusion Criteria:

• Permanent left ventricular epicardial defibrillator in place

• Congenital heart disease with single ventricle physiology

• Right ventricular assist device (RVAD) in place

• Existing pacing indication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Medtronic

Investigators

• Principal Investigator: Joseph Rogers, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01446796
• Other Study ID Numbers: Pro00026676
• First Posted: Oct 5, 2011
• Last Update Posted: Mar 10, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Duke University: Ventricular assist device
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Pre-assignment Detail	One subject provided initial consent but withdrew his consent prior to undergoing left ventricular assist device implantation. No further research activities for the study were performed with respect to this subject.

Arm/Group Title	Continuous RV Pacing	Native Conduction
Arm/Group Description	Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats	Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
Period Title: Overall Study
STARTED	3	0
COMPLETED	2	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Continuous RV Pacing
Arm/Group Description	Study terminated early due to recruitment
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 33.3%
>=65 years	2 66.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (10)
Sex: Female, Male (Count of Participants)
Female	1 33.3%
Male	2 66.7%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

Title	Length of Hospitalization
Description	To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

Study terminated early

Arm/Group Title	Native Conduction	Continuous RV Pacing
Arm/Group Description	Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.	Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
Measure Participants	0	0

2. Secondary Outcome

Title	Post-operative Need for Hemodynamic / Respiratory Support
Description	To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

Study terminated early due to low accrual. No data analysis completed.

Arm/Group Title	Continuous RV Pacing	Native Conduction
Arm/Group Description	Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats	Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
Measure Participants	0	0

3. Secondary Outcome

Title	Right Ventricular Function
Description	To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

Study terminated early due to low accrual. No data analysis completed.

Arm/Group Title	Native Conduction	Continuous RV Pacing
Arm/Group Description	Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.	Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
Measure Participants	0	0

4. Secondary Outcome

Title	Functional Capacity and Symptoms
Description	To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

Study terminated early due to low accrual. No data analysis completed.

Arm/Group Title	Native Conduction	Continuous RV Pacing
Arm/Group Description	Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.	Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
Measure Participants	0	0

Adverse Events

Arm/Group Title	Native Conduction		Continuous RV Pacing
Arm/Group Description	Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.		Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
All Cause Mortality
	Native Conduction		Continuous RV Pacing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Native Conduction		Continuous RV Pacing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Native Conduction		Continuous RV Pacing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.