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NCT01735916 · ClinicalTrials.gov registry record · NA
MIRACLE EF Clinical Study
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Terminated
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT01735916: Clinical Trial NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01735916 is a NA study that was terminated before completion, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01735916, a NA study, was terminated before completion, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- TERMINATED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
This study is looking at whether the electrical treatment provided by a special type of pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are electrically paced to beat together by the CRT pacemaker, blood may be pumped to the body more efficiently. The CRT pacemaker being studied in this clinical trial is approved by the US Food and Drug Administration (FDA) for patients with moderate to severe heart failure, whose hearts pump blood inefficiently. In the MIRACLE EF study, patients who have heart failure with slightly less inefficient hearts will be observed to see if the electrical pacing treatment is better than not getting the treatment. This study is being conducted to support FDA approval of this type of pacemaker for people whose heart failure is less inefficient.
Primary Outcome
Primary Efficacy Endpoint: The time to first event, with event defined as: * All-cause mortality, or * HF Event, defined as either: * Inpatient hospitalization for HF, or * Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay Note: No endpoints were reached, so this objective was not analyzed
Interventions
- DEVICE CRT-P Implant
- DEVICE CRT-P OFF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-03 |
| Phase | NA |
Why NCT01735916 stopped before completion
NCT01735916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which CRT-P Implant is the first listed.
NCT01735916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01735916 about?
NCT01735916 is a clinical study titled "MIRACLE EF Clinical Study". This study is looking at whether the electrical treatment provided by a special type of pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are electrically paced to beat together ...
What is the current status of trial NCT01735916?
This trial is currently terminated. It is a NA study. The enrollment target is 44 participants. The study started on 2012-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01735916?
The interventions under investigation include: CRT-P Implant (DEVICE), CRT-P OFF (DEVICE).
Who is sponsoring clinical trial NCT01735916?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01735916's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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