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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Paced QRS Duration as a Marker of Sudden Cardiac Death

NCT01948206

Sudden Cardiac Death

TERMINATED

The Left Bundle Cardiac Resynchronization Therapy Trial

NCT05434962

Left Bundle-Branch Block Heart Failure Impaired Left Ventricular Function

ACTIVE_NOT_RECRUITING NA

Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy

NCT00001530

Cardiomyopathy, Hypertrophic

COMPLETED

Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

NCT04496518

Ventricular Tachycardia

ACTIVE_NOT_RECRUITING

Clinical Prospective ranDomized Trial to Evaluate the Non-inferiority of Left Bundle Branch Area Pacing Vs Cardiac ResynchronIzatioN Therapy With ECG guIded AV Optimization

NCT07107048

Heart Failure

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Right Bundle-Branch Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Intervention Type DEVICE

ICD programmed to BiV pacing at a lower rate of 40

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VVI-40

Pacing mode set to VVI-40, RV only pacing

Intervention Type DEVICE

RV DDD-40

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

Intervention Type DEVICE

BiV DDD-40

ICD programmed to BiV pacing at a lower rate of 40

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No