Trial · NCT00187278
Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
NCT00187278, Not applicable, Completed, Abbott Medical Devices; results first posted 2021-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization. Trials, record NCT00187278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00187278
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
- NCT number
- NCT00187278
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,833 participants, actual
- Lead sponsor
- Abbott Medical Devices
- Conditions
- Atrioventricular Block, Ventricular Dysfunction
- Interventions
- Biventricular Pacing, RV Pacing
- First posted
- 2005-09-16
- Last updated
- 2021-01-25
- Results first posted
- 2021-01-25
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Mortality | Study duration (5.7 years mean follow-up) | Number of deaths observed |
| Primary | Death or Heart Failure Hospitalization | Study duration (5.7 years mean follow-up) | Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization |
| Secondary | Death Due to Cardiovascular Causes | Study duration (5.7 years mean follow-up) | Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC) |
| Secondary | Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test | 12 months post-implant | |
| Secondary | Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | 12 months post-implant | Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. |
| Secondary | Incidence of Hospitalizations for Deterioration of Heart Failure | Study duration (5.7 years mean follow-up) | |
| Secondary | Incidence of Hospitalizations for Cardiovascular Events | Study duration (5.7 years mean follow-up) | |
| Secondary | Incidence of Hospitalizations for Any Reason | Study duration (5.7 years mean follow-up) | |
| Secondary | Cardiac Structure and Function | 12 & 24 months | |
| Secondary | Successful Implantation of the Left Ventricular Lead | Implantation |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Mortality | Study duration (5.7 years mean follow-up) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Death or Heart Failure Hospitalization | Study duration (5.7 years mean follow-up) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Death Due to Cardiovascular Causes | Study duration (5.7 years mean follow-up) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test | 12 months post-implant | This analysis includes all enrolled patients who completed the 6-minute walk test both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. | meters | MEAN |
| SECONDARY | Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | 12 months post-implant | This analysis includes all enrolled patients who completed the Minnesota Living With Heart Failure questionnaire both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. | score on a scale | MEAN |
| SECONDARY | Incidence of Hospitalizations for Deterioration of Heart Failure | Study duration (5.7 years mean follow-up) | hospitalization per patient year | NUMBER | |
| SECONDARY | Incidence of Hospitalizations for Cardiovascular Events | Study duration (5.7 years mean follow-up) | hospitalizations per patient year | NUMBER | |
| SECONDARY | Incidence of Hospitalizations for Any Reason | Study duration (5.7 years mean follow-up) | Hospitalization per patient year | NUMBER | |
| SECONDARY | Cardiac Structure and Function | 12 & 24 months | Data related to cardiac structure and function can not be presented as the data was not collected and analysis provided by the core lab. | ||
| SECONDARY | Successful Implantation of the Left Ventricular Lead | Implantation | There was an attempt of left ventricular lead implantation only for subjects from Biventricular Pacing group. | participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Mortality | RV Pacing | 307 | Participants | ||
| Total Mortality | Biventricular Pacing | 305 | Participants | ||
| Death or Heart Failure Hospitalization | RV Pacing | 346 | Participants | ||
| Death or Heart Failure Hospitalization | Biventricular Pacing | 363 | Participants | ||
| Death Due to Cardiovascular Causes | RV Pacing | 106 | Participants | ||
| Death Due to Cardiovascular Causes | Biventricular Pacing | 107 | Participants | ||
| Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test | RV Pacing | 371.3 | Standard Deviation 128.8 | meters | |
| Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test | Biventricular Pacing | 371.2 | Standard Deviation 129.1 | meters | |
| Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | RV Pacing | 16.0 | Standard Deviation 15.4 | score on a scale | |
| Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© | Biventricular Pacing | 15.3 | Standard Deviation 15.5 | score on a scale |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RV Pacing | 918 | |
| Overall Study | STARTED | Biventricular Pacing | 915 | |
| Overall Study | COMPLETED | RV Pacing | 908 | |
| Overall Study | COMPLETED | Biventricular Pacing | 902 | |
| Overall Study | NOT COMPLETED | RV Pacing | 10 | |
| Overall Study | NOT COMPLETED | Biventricular Pacing | 13 |
Source ClinicalTrials.gov
Adverse events652
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | RV Pacing | 5 | 908 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Biventricular Pacing | 4 | 902 | 4 |
| other | Bicytopenia | Blood and lymphatic system disorders | RV Pacing | 0 | 908 | 0 |
| other | Bicytopenia | Blood and lymphatic system disorders | Biventricular Pacing | 1 | 902 | 1 |
| other | Epistaxis | Blood and lymphatic system disorders | RV Pacing | 1 | 908 | 2 |
| other | Epistaxis | Blood and lymphatic system disorders | Biventricular Pacing | 3 | 902 | 3 |
| other | Hematochezia | Blood and lymphatic system disorders | RV Pacing | 1 | 908 | 1 |
| other | Hematochezia | Blood and lymphatic system disorders | Biventricular Pacing | 0 | 902 | 0 |
| other | Hypereosinophilia | Blood and lymphatic system disorders | RV Pacing | 0 | 908 | 0 |
| other | Hypereosinophilia | Blood and lymphatic system disorders | Biventricular Pacing | 1 | 902 | 1 |
1 to 10 of 652Source ClinicalTrials.gov
See all 652 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RV Pacing | 307 | 908 |
| Total, all-cause mortality | Biventricular Pacing | 305 | 902 |
| Total, other adverse events | RV Pacing | 451 | 908 |
| Total, other adverse events | Biventricular Pacing | 507 | 902 |
| Total, serious adverse events | RV Pacing | 641 | 908 |
| Total, serious adverse events | Biventricular Pacing | 698 | 902 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| RV Pacing vs Biventricular Pacing: Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits) | Trial comparisons |
| RV Pacing vs Biventricular Pacing: Total Mortality | Trial comparisons |
| RV Pacing vs Biventricular Pacing: Adverse Events Related to Left Ventricular Lead | Trial comparisons |
| RV Pacing vs Biventricular Pacing: Death Due to Cardiovascular Causes | Trial comparisons |
| RV Pacing vs Biventricular Pacing: Death or Heart Failure Hospitalization | Trial comparisons |
| RV Pacing vs Biventricular Pacing: deaths from any cause | Trial comparisons |
| RV Pacing vs Biventricular Pacing: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00187278
GET https://conductscience.org/api/trials/v1/NCT00187278/results?page=2