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Biventricular Versus Right Ventricular Pacing
NA trial testing Biventricular Pacing in Heart Failure in 1 participant. Terminated before completion.
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 9 August 2023 |
| Primary completion | 10 November 2023 |
| Estimated completion | 10 November 2023 |
| Sites | 1 location across United States |
Indiana University
18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.
| Group | Value | 95% CI |
|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | 350 |
| Group | Value | 95% CI |
|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | 375 |
Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as either no problems (score of 1), some problems (score of 2), or extreme problems (score of 3). Higher scores indicating a poorer overall quality of life in these dimensions. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1:
| Group | Value | 95% CI |
|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | -0.293 |
Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.
| Group | Value | 95% CI |
|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | 470 |
| Group | Value | 95% CI |
|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | 515 |
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing