Ischemic or Non-ischemic Cardiomyopathy, Non-left Bundle Branch Block
Conditions
Keywords
Non-left bundle branch block, QLV, LV lead pacing location, CRT-D
Brief summary
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
Detailed description
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients. In the QLV arm the physician will: 1. Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement. 2. Measure QLV for each of the four cathodes of the left ventricular lead in each branch. 3. Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode. In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach. The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
Interventions
DEVICEQLV based implant strategy
DEVICEStandard of care implant strategy
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration ≥ 120ms) * Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines: * Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-LBBB pattern with QRS duration ≥ 120 ms, and NYHA) class III/ambulatory class IV on guideline directed medical therapy * Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing * Are 18 years or older, or of legal age to give informed consent specific to state and local law * Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion criteria
* Irreversible occlusion of venous access that will prevent placement of the CRT system either through the right or left upper extremity venous system * Undergoing left ventricular lead placement via a surgical or epicardial approach * Cardiomyopathy due solely to valvular disease that is not repaired/replaced * Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by St. Jude Medical, during the course of this clinical study * LBBB: QRS width ≥ 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6 * Incomplete right bundle branch block - intraventricular conduction delay with a QRS duration between 110 and 119ms * Persistent or permanent atrial fibrillation * Pacemaker dependent * Patients who are being upgraded primarily due to right ventricular pacing * Women who are pregnant or who plan to become pregnant during the clinical trial * Life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Improved Clinical Composite Score | 12 months | Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are markedly worse, moderately worse, slightly worse, no change, slightly better, moderately better, markedly better. CCS components were used to classify or score subjects as IMPROVED (at least one-class improvement in NYHA Class or improvement by PGA moderately or markedly better AND no HF events AND no cardiovascular death), or WORSENED (worsening in NYHA Class OR worsening by PGA moderately or markedly worse OR presence of HF events OR Cardiovascular death, or UNCHANGED (neither improved or worsened). Note CCS is not a numeric score. |
Countries
United States
Participant flow
Pre-assignment details
The study enrolled 248 subjects, with 247 having an attempted implant. Of the 247 subjects with an attempted implant, three subjects were excluded from analysis based on having a LBBB morphology and two excluded based on QRS duration \<120 ms.
Participants by arm
| Arm | Count |
|---|---|
| QLV Study Arm The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle. | 161 |
| Standard of Care Study Arm The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach. | 81 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing 12-month visit | 3 | 3 |
| Overall Study | Missing NYHA/Patient Global Assessment | 1 | 1 |
| Overall Study | Withdrawal by Subject | 29 | 15 |
Baseline characteristics
| Characteristic | Total | QLV Study Arm | Standard of Care Study Arm |
|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 12.5 | 65.7 years STANDARD_DEVIATION 12.1 | 64.1 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 222 Participants | 147 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| NYHA Classification NYHA II | 1 Participants | 0 Participants | 1 Participants |
| NYHA Classification NYHA III | 228 Participants | 157 Participants | 71 Participants |
| NYHA Classification NYHA IV | 13 Participants | 4 Participants | 9 Participants |
| QRS Duration 120-149 msec | 108 Participants | 75 Participants | 33 Participants |
| QRS Duration >= 150 msec | 134 Participants | 86 Participants | 48 Participants |
| Sex: Female, Male Female | 48 Participants | 27 Participants | 21 Participants |
| Sex: Female, Male Male | 194 Participants | 134 Participants | 60 Participants |
| Type of Cardiomyopathy Ischemic | 145 Participants | 100 Participants | 45 Participants |
| Type of Cardiomyopathy None | 9 Participants | 6 Participants | 3 Participants |
| Type of Cardiomyopathy Non-ischemic | 88 Participants | 55 Participants | 33 Participants |
| Types of QRS Morphology Intraventricular Conduction Delay | 88 Participants | 55 Participants | 33 Participants |
| Types of QRS Morphology Other | 5 Participants | 3 Participants | 2 Participants |
| Types of QRS Morphology Right Bundle Branch Block | 122 Participants | 86 Participants | 36 Participants |
| Types of QRS Morphology Right Bundle Branch/Left Anterior Fascicular Block | 24 Participants | 15 Participants | 9 Participants |
| Types of QRS Morphology Right Bundle/Left Posterior Fascicular Block | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 62 | 9 / 128 |
| other Total, other adverse events | 14 / 62 | 31 / 128 |
| serious Total, serious adverse events | 4 / 62 | 8 / 128 |
Outcome results
Primary
Number of Patients With Improved Clinical Composite Score
Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are markedly worse, moderately worse, slightly worse, no change, slightly better, moderately better, markedly better. CCS components were used to classify or score subjects as IMPROVED (at least one-class improvement in NYHA Class or improvement by PGA moderately or markedly better AND no HF events AND no cardiovascular death), or WORSENED (worsening in NYHA Class OR worsening by PGA moderately or markedly worse OR presence of HF events OR Cardiovascular death, or UNCHANGED (neither improved or worsened). Note CCS is not a numeric score.
Time frame: 12 months
Population: Of the 242 subjects enrolled, 44 withdrew for reasons other than cardiac death, six had a missing 12-month visit for reasons other than a heart failure event and two had missing Patient Global Assessments or NYHA classification assessments. As a result, the primary endpoint analysis included 190 enrolled subjects (128 QLV arm; 62 control arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QLV Study Arm | Number of Patients With Improved Clinical Composite Score | 86 Participants |
| Standard of Care Study Arm | Number of Patients With Improved Clinical Composite Score | 45 Participants |
p-value: 0.001Fisher Exact