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

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01169493
First received: July 22, 2010
Last updated: August 28, 2015
Last verified: August 2015
Results First Received: August 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Heart Failure
Right Bundle-Branch Block
Interventions: Device: VVI-40
Device: RV DDD-40
Device: BiV DDD-40

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
VVI-40 to RV DDD-40 to Bi-V DDD-40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

Bi-V DDD-40 to VVI-40 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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40


Participant Flow:   Overall Study
    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  
STARTED     2     4     5     0     5     0  
COMPLETED     2     3     3     0     4     0  
NOT COMPLETED     0     1     2     0     1     0  
Withdrawal by Subject                 0                 1                 0                 0                 1                 0  
Physician Decision                 0                 0                 2                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
VVI-40 to RV DDD-40 to Bi-V DDD-40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

Bi-V DDD-40 to VVI-40 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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

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

VVI-40: Pacing mode set to VVI-40, RV only pacing

RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.

BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40

Total Total of all reporting groups

Baseline Measures
    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     Total  
Number of Participants  
[units: participants]
  2     4     5     0     5     0     16  
Age  
[units: participants]
             
<=18 years     0     0     0         0         0  
Between 18 and 65 years     0     1     0         2         3  
>=65 years     2     3     5         3         13  
Gender  
[units: participants]
             
Female     0     0     0         0         0  
Male     2     4     5         5         16  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Secondary Echocardiographic Endpoints   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Secondary Endpoints of the PACE-RBBB Trial Will Also Include Comparisons of NYHA Functional Class, 6-minute Walk Distance, and Minnesota Quality of Life Questionnaire Scores Between Treatment Groups.   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Arrhythmic Events   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We were unable to enroll adequately, and the study was underpowered to assess either the safety or efficacy of RV only, or BIV pacing in patients with right bundle branch block.


  More Information
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Certain Agreements:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: Brett D. Atwater, MD
Organization: Duke University Medical Center
phone: 9196848111
e-mail: brett.atwater@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01169493     History of Changes
Other Study ID Numbers: Pro00025144
10CRP3630033 ( Other Grant/Funding Number: American Heart Association )
Study First Received: July 22, 2010
Results First Received: August 28, 2015
Last Updated: August 28, 2015
Health Authority: United States: Institutional Review Board