N/A
N=918
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Atrioventricular Block · Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00267098 ↗Enrolled (actual)
918
Serious AEs
53.5%
Results posted
Mar 2014
Primary outcome: Primary: Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) — 160; 191; 93; 136 participants — p=0.9990
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardiac Resynchronization Therapy (CRT) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) |
160; 191; 93; 136; 70; 94 | 0.9990 |
| SECONDARY All-Cause Mortality |
80; 94; 269; 248 | 0.865 |
| SECONDARY All-Cause Mortality or Heart Failure-related Hospitalization |
121; 135; 80; 94; 79; 92 | 0.9785 |
| SECONDARY All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index |
131; 171; 55; 66; 93; 136 | 0.9886 |
| SECONDARY First Heart Failure Hospitalization |
79; 92; 270; 250 | 0.9904 |
| SECONDARY Days Hospitalized for Heart Failure |
1.89; 2.63 | 0.637 |
| SECONDARY Change in New York Heart Association Classification |
5; 3; 54; 43; 200; 205 | 0.591 |
| SECONDARY Change in Heart Failure Stage |
1; 0; 11; 5; 296; 274 | 0.534 |
| SECONDARY Change in Cardiovascular Medications |
173; 179; 93; 84; 186; 191 | — |
| SECONDARY Frequency of Adverse Events Post-randomization |
37; 7; 7; 2; 56; 31 | — |
| SECONDARY Cardiovascular-related Healthcare Utilizations |
264; 263; 164; 162; 118; 128 | — |
| SECONDARY Change in Quality of Life at 6 Months |
5; 0.3 | 0.9976 |
| SECONDARY Change in Quality of Life at 12 Months |
3.9; 0.9 | 0.9641 |
| SECONDARY Change in Quality of Life at 18 Months |
2.3; 0.5 | 0.8416 |
| SECONDARY Change in Quality of Life at 24 Months |
2.6; 1.5 | 0.7270 |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months |
3.0; -0.3 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months |
2.7; -0.5 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months |
2.7; 0.4 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months |
2.0; -1.6 | — |
| SECONDARY Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months |
-6.8; 0.4 | — |
| SECONDARY Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months |
-6.8; 0.5 | — |
| SECONDARY Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months |
-8.8; -0.5 | — |
| SECONDARY Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months |
-6.0; 1.4 | — |
| SECONDARY Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months |
-6.2; -0.3 | — |
| SECONDARY Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months |
-7.0; -1.1 | — |
| SECONDARY Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months |
-9.8; -0.8 | — |
| SECONDARY Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months |
-6.9; -0.1 | — |
| SECONDARY Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months |
-8.4; -4.2 | — |
| SECONDARY Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months |
-15.8; -4.7 | — |
| SECONDARY Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months |
-16.8; -7.2 | — |
| SECONDARY Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months |
-19.4; -6.8 | — |
| SECONDARY Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months |
-0.1; 0.0 | — |
| SECONDARY Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months |
-0.1; 0.0 | — |
| SECONDARY Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months |
-0.2; 0.0 | — |
| SECONDARY Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months |
-0.3; 0.0 | — |
| SECONDARY Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months |
-0.1; 0.0 | — |
| SECONDARY Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months |
0.0; 0.1 | — |
| SECONDARY Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months |
-0.1; 0.0 | — |
| SECONDARY Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months |
-0.1; 0.1 | — |
| SECONDARY Change in Mitral Regurgitation From Randomization to 6 Months |
-1.3; -0.6 | — |
| SECONDARY Change in Mitral Regurgitation From Randomization to 12 Months |
-1.3; -0.8 | — |
| SECONDARY Change in Mitral Regurgitation From Randomization to 18 Months |
-1.9; -1.9 | — |
| SECONDARY Change in Mitral Regurgitation From Randomization to 24 Months |
-1.1; -0.5 | — |
| SECONDARY Change in Cardiac Index From Randomization to 6 Months |
0; -0.1 | — |
| SECONDARY Change in Cardiac Index From Randomization to 12 Months |
-0.1; -0.2 | — |
| SECONDARY Change in Cardiac Index From Randomization to 18 Months |
-0.1; 0 | — |
| SECONDARY Change in Cardiac Index From Randomization to 24 Months |
-0.1; -0.2 | — |
| SECONDARY Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months |
49.9; -4.2 | — |
| SECONDARY Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months |
38.5; 0.4 | — |
| SECONDARY Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months |
55.1; -0.8 | — |
| SECONDARY Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months |
48.6; -4.9 | — |
| SECONDARY Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months |
0; 0 | — |
| SECONDARY Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months |
0.1; 0.2 | — |
| SECONDARY Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months |
0.1; 0.1 | — |
| SECONDARY Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months |
0.2; 0.1 | — |
| SECONDARY Clinical Composite Score at 6 Months |
184; 133; 83; 113; 82; 96 | 0.9985 |
| SECONDARY Clinical Composite Score at 12 Months |
160; 117; 82; 78; 103; 146 | 0.9999 |
| SECONDARY Clinical Composite Score at 18 Months |
137; 103; 68; 70; 120; 150 | 0.9978 |
| SECONDARY Clinical Composite Score at 24 Months |
118; 94; 70; 59; 120; 161 | 0.9983 |
| SECONDARY CRT-P and CRT-D System Implant Success |
531; 227; 30; 21 | — |
| SECONDARY Incidence of Ventricular Tachyarrhythmias |
39; 31; 67; 70 | 0.189 |
Summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the heartbeat. In this trial, the researchers will test if pacing both the left and right lower half of the heart (ventricles) will:
* decrease the number of hospital and clinic visits due to heart failure symptoms
* extend life
* delay heart failure symptoms as compared to those who are paced in only one ventricle (the right ventricle)
Eligibility Criteria
Inclusion Criteria
- Subject has standard class I or class IIa indication for pacemaker implantation in accordance with ACC/AHA/HRS guidelines
- Subjects diagnosed with atrioventricular (AV) block. An AV block is a disturbance when the heart's natural pacemaker sends a message from the atrium (top part of heart) to the ventricle (bottom part of heart) and the message is partially or totally blocked
- Subject is receiving first time implant
- Subjects with heart failure but no symptoms of it (New York Heart Association [NYHA] Class I), or subjects with mild heart failure that only sometimes interferes with their daily activities (NYHA Class II), or subjects with heart failure that severely limits daily activities (NYHA Class III)
- Subjects with documented reduced heart pumping function (left ventricular ejection fraction ≤ 50%) within past 90 days
- Subject is at least 18 years old
- Subject or authorized legal guardian or representative has signed and dated the Informed Consent
- Subject is able to receive a pectoral implant
- Subject is expected to remain available for follow-up visits at the study center
- Subject is willing and able to comply with the protocol
Exclusion Criteria
- Subject has ever had a previous or has an existing device implant
- Subjects with some forms of chest pain or myocardial infarction (heart attack) within the past 30 days
- Subjects with coronary bypass within the past 30 days
- Subjects with stent within the past 30 days
- Subjects with valve repair or replacement within the past 6 months or is indicated for repair or replacement
- Subjects with a mechanical right heart valve
- Subject is indicated for a biventricular pacing device (CRT-P or CRT-D devices)
- Subject is enrolled in a concurrent study which may confound the results of this study (co-enrollment in any concurrent clinical study requires approval of the study manager)
- Subject is pregnant, or of child bearing potential and not on a reliable form of birth control
- Subjects with a previous heart transplant
- Subjects has been classified as NHYA Functional Class IV within prior 90 days (subjects with severe heart failure and should always be resting)
- Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
Data sourced from ClinicalTrials.gov (NCT00267098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.