The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.
This study is a multi-center, prospective, randomized, blinded trial. The study will consist of approximately 265 patients who require treatment of persistent or permanent, symptomatic atrial fibrillation by atrioventricular (AV) node ablation and permanent pacing therapy i.e. "Ablate and Pace" therapy. All patients enrolled into the clinical study will be randomly assigned to one of three groups using a randomization ratio of 2:2:1. Patients will be assigned to receive either biventricular (biV) pacing with CLS-based rate adaptive pacing using the legally marketed Protos DR/CLS (Group 1), or biventricular pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 2), or right ventricular (RV) pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 3). Patients in all three groups will be implanted with legally marketed right and left ventricular pacing leads. The patients, the core lab used to interpret the echocardiographic data and the Clinical Events Committee adjudicating crossover, patient death and congestive heart failure (CHF) hospitalizations will be blinded to the randomization assignment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
153
Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption
University of Alabama
Birmingham, Alabama, United States
Lake Charles Memorial
Lake Charles, Louisiana, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
St. Joseph Mercy
Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months
Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))
Time frame: Change from baseline to six months post-procedure
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.
Time frame: At six months post-procedure
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications. All Stratos systems (in both the biV and RV pacing arms) were evaluated together as pre-specified in the protocol.
Time frame: At six months post-procedure
Change in Six-minute Walk Test
Time frame: Change from baseline to 6 months post-procedure
Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months
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Ann Arbor, Michigan, United States
McLaren Heart Foundation
Lapeer, Michigan, United States
NYU Medical Center
New York, New York, United States
Aultman Hospital
Canton, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Spartanburg Regional
Spartanburg, South Carolina, United States
Lone Star Arrhythmia
Amarillo, Texas, United States
Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. This outcome was calculated as QOL score at baseline minus QOL score at 6 months. Therefore, a positive change in QOL score represents an improvement in quality of life, while a negative change in QOL score represents a worsening.
Time frame: Change from baseline to six months post-procedure
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction
Time frame: Change from baseline to six months post-procedure
Changes in New York Heart Association (NYHA) Classification
The purpose is to evaluate the change in the participant's NYHA classification. There are four NYHA classes: Class I: Patients with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: Change from baseline to six months post-procedure
Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations
Time frame: At six months post-procedure
Mortality Rate
Time frame: At six months post-procedure
Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume
Time frame: Change from baseline to six months post-procedure
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass
Time frame: Change from baseline to six months post-procedure
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume
Time frame: Change from baseline to six months post-procedure
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume
Time frame: Change from baseline to six months post-procedure