CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,742 enrolled
Drug / intervention
Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devicesdevice
Likely dose
Atrial support pacing programming via RENEWAL family CRT-D devices at variable lower rate limitsAI-extracted
Key inclusion· 5
  • ✓Meets FDA indications for CONTAK RENEWAL or future FDA-approved Guidant CRT-D devices
  • ✓Sinus rhythm at time of implant
  • ✓On optimal pharmacologic therapy or requiring ICD for new indication with concurrent pharmacologic optimization
  • ✓Remains in clinical care of enrolling physician at approved centers
Key exclusion· 9
  • ✕Permanent atrial fibrillation or atrial flutter
  • ✕Complete heart block
  • ✕Prior pacemaker, ICD, or CRT device
  • ✕Life expectancy <12 months due to other medical conditions

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

Search/NCT00146848
NCT00146848Phase 4Completed
CompareCT.gov

Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

Boston Scientific Corporation·interventional·Posted Sep 7, 2005·Updated Dec 28, 2011

In Brief

A Phase 4 clinical trial evaluating Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices for Heart Failure. Completed, enrolled 1,742 participants across 1 site.

Detailed Summary

This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartDec 1, 2004
Primary CompletionJan 1, 2009
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devicesdevice

All subjects in this trial receive the same device. For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.