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NCT03008291 · ClinicalTrials.gov registry record

His Bundle Pacing in Bradycardia and Heart Failure

A clinical trial of Heart Failure and Bradycardia, sponsored by Yong-Mei Cha.

Recruiting
Registry status
80
Enrollment target
1
Study location

NCT03008291 is a study of Heart Failure and Bradycardia that is actively recruiting participants, run by Yong-Mei Cha. The registered enrollment target is 80 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03008291, a study of Heart Failure and Bradycardia, is actively recruiting participants, sponsored by Yong-Mei Cha.

RECRUITING
Registry status
80 participants
Enrollment target
1
Study location

Study Summary

Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders), or have atrioventricular (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block. The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).

Interventions

  • PROCEDURE CRT-D Implantation
  • PROCEDURE CRT-P Implantation
  • PROCEDURE Dual Chamber Pacemaker Implantation

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2016-10
Est. Completion 2026-12

Sponsor

Yong-Mei Cha

2 total trials

What the Registry Record Tells You About NCT03008291

The ClinicalTrials.gov registry entry for NCT03008291 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (96% lower). The listed sponsor is Yong-Mei Cha, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 3 interventions - of which CRT-D Implantation is the first listed.

NCT03008291 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT03008291 about?

NCT03008291 is a clinical study titled "His Bundle Pacing in Bradycardia and Heart Failure". Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LB...

What is the current status of trial NCT03008291?

This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2016-10. Estimated completion is 2026-12.

What conditions does trial NCT03008291 study?

This clinical trial studies the following conditions: Heart Failure, Bradycardia.

What interventions are being tested in trial NCT03008291?

The interventions under investigation include: CRT-D Implantation (PROCEDURE), CRT-P Implantation (PROCEDURE), Dual Chamber Pacemaker Implantation (PROCEDURE).

Who is sponsoring clinical trial NCT03008291?

This trial is sponsored by Yong-Mei Cha, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03008291 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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