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Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial) (PACE-RBBB)

Primary Purpose

Heart Failure, Right Bundle-Branch Block

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VVI-40
RV DDD-40
BiV DDD-40
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Right Bundle-Branch Block, Cardiac Resynchronization Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cardiomyopathy of either idiopathic or ischemic etiology
  • NYHA class III, or IV symptoms
  • Sinus rhythm
  • QRS complex duration > 130 msec in ≥ 2 surface ECG leads with RBBB
  • PR interval > 150 msec and < 240 msec
  • Prior implantation of dual chamber BiV ICD with apical RV lead location

Exclusion Criteria:

  • Myocardial infarction, major surgical procedure, or acute cardiac failure crisis requiring inotropes within 6 months of entry into the study
  • Atrial fibrillation or flutter lasting >12 hours within the last 6 months
  • Sick sinus syndrome, complete heart block, or other arrhythmias requiring pacemaker support
  • Pregnancy
  • Any other known condition other than heart failure that could limit exercise time or survival to < 6 months

Sites / Locations

  • Duke University Medical Center
  • Durham VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

VVI-40 to RV DDD-40 to Bi-V DDD-40

VVI-40 to Bi-V DDD-40 to RV DDD-40

Bi-V DDD-40 to VVI-40 to RV DDD-40

Bi-V DDD-40 to RV DDD-40 to VVI-40

RV DDD-40 to VVI-40 to Bi-V DDD-40

RV DDD-40 to Bi-V DDD-40 to VVI-40

Arm Description

Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40

Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40

Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40

Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40

Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40

Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40

Outcomes

Primary Outcome Measures

The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.

Secondary Outcome Measures

Secondary Echocardiographic Endpoints
Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.
Arrhythmic Events
To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.
Minnesota Quality of Life Questionnaire
This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.
6-minute Walk Distance
6-minute walk distance was the distance that a participant could walk in 6 minutes.
NYHA Function Class
The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular End-diastolic Size

Full Information

First Posted
July 22, 2010
Last Updated
August 1, 2016
Sponsor
Duke University
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01169493
Brief Title
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)
Acronym
PACE-RBBB
Official Title
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis. Approximately half of all HF patients have electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a perturbation of the normal pattern of ventricular contraction that reduces the efficiency of ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF symptomatology in this subset of patients. Resynchronization of ventricular contraction is usually achieved through simultaneous pacing of the left and right ventricles using a biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial evidence supporting the use of BiV pacing in patients with prolonged QRS duration was obtained almost exclusively in patients with a left bundle-branch block (LBBB) electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular contraction in patients with LBBB can be obtained by univentricular left ventricular pacing with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that ventricular resynchronization can be obtained in subjects with right bundle-branch block (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac death. Most of these devices are currently programmed to avoid RV pacing. We aim to determine if ventricular resynchronization delivered through univentricular RV pacing improves symptoms in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD implantation for symptomatic heart failure. We further aim to determine if ventricular resynchronization improves myocardial performance and ventricular geometry as detected by echocardiographic measures and quality of life for patients with HF and RBBB. We hypothesize that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF symptoms, and positive ventricular remodeling in patients with HF and RBBB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Right Bundle-Branch Block
Keywords
Heart Failure, Right Bundle-Branch Block, Cardiac Resynchronization Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VVI-40 to RV DDD-40 to Bi-V DDD-40
Arm Type
Experimental
Arm Description
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
Arm Title
VVI-40 to Bi-V DDD-40 to RV DDD-40
Arm Type
Experimental
Arm Description
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
Arm Title
Bi-V DDD-40 to VVI-40 to RV DDD-40
Arm Type
Experimental
Arm Description
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
Arm Title
Bi-V DDD-40 to RV DDD-40 to VVI-40
Arm Type
Experimental
Arm Description
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
Arm Title
RV DDD-40 to VVI-40 to Bi-V DDD-40
Arm Type
Experimental
Arm Description
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
Arm Title
RV DDD-40 to Bi-V DDD-40 to VVI-40
Arm Type
Experimental
Arm Description
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
Intervention Type
Device
Intervention Name(s)
VVI-40
Intervention Description
Pacing mode set to VVI-40, RV only pacing
Intervention Type
Device
Intervention Name(s)
RV DDD-40
Intervention Description
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
Intervention Type
Device
Intervention Name(s)
BiV DDD-40
Intervention Description
ICD programmed to BiV pacing at a lower rate of 40
Primary Outcome Measure Information:
Title
The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary Echocardiographic Endpoints
Description
Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.
Time Frame
6 months
Title
Arrhythmic Events
Description
To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.
Time Frame
6 months
Title
Minnesota Quality of Life Questionnaire
Description
This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.
Time Frame
6 months
Title
6-minute Walk Distance
Description
6-minute walk distance was the distance that a participant could walk in 6 minutes.
Time Frame
6 months
Title
NYHA Function Class
Description
The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.
Time Frame
6 months
Title
Left Ventricular Ejection Fraction (LVEF)
Time Frame
6 months
Title
Left Ventricular End-diastolic Size
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiomyopathy of either idiopathic or ischemic etiology NYHA class III, or IV symptoms Sinus rhythm QRS complex duration > 130 msec in ≥ 2 surface ECG leads with RBBB PR interval > 150 msec and < 240 msec Prior implantation of dual chamber BiV ICD with apical RV lead location Exclusion Criteria: Myocardial infarction, major surgical procedure, or acute cardiac failure crisis requiring inotropes within 6 months of entry into the study Atrial fibrillation or flutter lasting >12 hours within the last 6 months Sick sinus syndrome, complete heart block, or other arrhythmias requiring pacemaker support Pregnancy Any other known condition other than heart failure that could limit exercise time or survival to < 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett D Atwater, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)

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