CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
INCEPTA ICD or CRT-Ddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01227785
NCT01227785N/ACompleted

Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients

Guidant Corporation·observational·Posted Oct 25, 2010·Updated Apr 25, 2014

In Brief

An observational study evaluating INCEPTA ICD or CRT-D for Sudden Cardiac Death and Heart Failure. Completed, enrolled 120 participants across 1 site.

Detailed Summary

This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these new devices work in patients. This new family is called the INCEPTA ICD and the INCEPTA CRT-D. The second purpose of the study is to collect data from a feature that monitors breathing. It is called the Respiratory Rate Trend (RRT). These data will help to better understand how changes in breathing relate to changes in clinical conditions.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.7 years ago

Interventions

INCEPTA ICD or CRT-Ddevice