Autopsy report · NCT01509495

Impedance Measurements in Heart Failure Patients

“Enrollment rate too low; rate much under estimation of sponsor and investigators”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 2 years 5 months before it stopped.
• 20 participants planned (an estimate, not an actual count).
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Medtronic BRC

Sponsor type

Industry

Conditions

Heart Failure

Interventions

Akern BIA101 and Custom Device

Participants

20 (planned, not actual)

Sites

3

Countries

Czechia, Germany, Slovakia

Trials that died the same way

• A Clinical Investigation Evaluating Peristeen® Performance
  “Lack of enrollment - Sponsor decision” (72% match in meaning)
• Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
  “Low rate of enrollment” (72% match in meaning)
• International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
  “Sponsor discretion (low recruitment rate)” (71% match in meaning)
• MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction
  “low enrollment rate” (70% match in meaning)
• Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
  “Low enrollment rates.” (70% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.