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NCT00187200 · ClinicalTrials.gov registry record · Phase 4

Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients

A Phase 4 study, sponsored by Abbott Medical Devices.

Completed
Registry status
Phase 4
Development phase
816
Enrollment target

NCT00187200: Completed Phase 4 study, sponsored by Abbott Medical Devices.

NCT00187200 is a Phase 4 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 816 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00187200, a Phase 4 study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
Phase 4
Development phase
816 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate. For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled: * \< 10% improvement in 6-minute hall walk, and * no class improvement or worsening in New York Heart Association (NYHA) scale. For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled: * \> 1 heart failure (HF) related hospitalization, and * no class improvement or worsening in NYHA scale.

Primary Outcome

Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is

Interventions

  • DEVICE Simultaneous VV Pacing
  • DEVICE Sequential VV Pacing

Trial Details

FieldValue
Enrollment Target 816 participants
Start Date 2005-01
Est. Completion 2010-04
Phase Phase 4
Abbott Medical Devices

261 total trials

What the finished NCT00187200 record still lists

NCT00187200 is an interventional study that assigns participants to a tested intervention. The registered 816 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% higher).

The record links to 0 conditions, and to 2 interventions - of which Simultaneous VV Pacing is the first listed.

NCT00187200 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00187200 about?

NCT00187200 is a clinical study titled "Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients". The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate. For patients enrolled with new CRT-...

What is the current status of trial NCT00187200?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 816 participants. The study started on 2005-01. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00187200?

The interventions under investigation include: Simultaneous VV Pacing (DEVICE), Sequential VV Pacing (DEVICE).

Who is sponsoring clinical trial NCT00187200?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00187200's enrollment target sits among peer trials

816 95th of 2000 higher than 1,906 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00187200, the US trial registry maintained by the National Library of Medicine. NCT00187200 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.