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NCT01129635 · ClinicalTrials.gov registry record · NA

Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging

A NA study, sponsored by Emory University.

Completed
Registry status
NA
Development phase
38
Enrollment target

NCT01129635: Completed NA study, sponsored by Emory University.

NCT01129635 is a NA study that has completed, run by Emory University. The registered enrollment target is 38 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.

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The verdict

NCT01129635, a NA study, has completed, sponsored by Emory University.

COMPLETED
Registry status
NA
Development phase
38 participants
Enrollment target

Study Summary

Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.

Primary Outcome

Parameter will be recorded for at least 10 consecutive heartbeats during sinus and RV paced rhythm Ts = The average time from the sensed RV IEGM to the peak of the LV impedance curve

Interventions

  • PROCEDURE Cardiac Resynchronization Therapy (CRT) implantation

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2010-06
Est. Completion 2014-12
Phase NA
Emory University

1,208 total trials

What the finished NCT01129635 record still lists

NCT01129635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 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 1 intervention - of which Cardiac Resynchronization Therapy (CRT) implantation is the first listed.

NCT01129635 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01129635 about?

NCT01129635 is a clinical study titled "Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging". Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of...

What is the current status of trial NCT01129635?

This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2010-06. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01129635?

The interventions under investigation include: Cardiac Resynchronization Therapy (CRT) implantation (PROCEDURE).

Who is sponsoring clinical trial NCT01129635?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01129635's enrollment target sits among peer trials

38 1538th of 2000 higher than 461 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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Source: ClinicalTrials.gov NCT01129635, the US trial registry maintained by the National Library of Medicine. NCT01129635 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.