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NCT06690333 · ClinicalTrials.gov registry record · NA

Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

A NA study of Pacemaker Implantation and AV Node Disease, sponsored by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH.

Recruiting
Registry status
NA
Development phase
75
Enrollment target
2
Study locations

NCT06690333: Recruiting NA study of Pacemaker Implantation and AV Node Disease, sponsored by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH.

NCT06690333 is a NA study of Pacemaker Implantation and AV Node Disease that is actively recruiting participants, run by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06690333, a NA study of Pacemaker Implantation and AV Node Disease, is actively recruiting participants, sponsored by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH.

RECRUITING
Registry status
NA
Development phase
75 participants
Enrollment target
2
Study locations

Study Summary

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.

Primary Outcome

The composite of: 1. procedural success 2. freedom from serious device-related complications at one year 3. freedom from heart failure or drop in ejection fraction below 50%.

Interventions

  • DEVICE Pacemaker

Study Locations (2)

Florida

  • NCH Healthcare - Naples

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2024-11-05
Est. Completion 2026-12
Phase NA

What NCT06690333 shows while recruiting

NCT06690333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Pacemaker Implantation appearing as the primary indexed condition, and to 1 intervention - of which Pacemaker is the first listed.

NCT06690333 reports a single indexed study location in Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06690333 about?

NCT06690333 is a clinical study titled "Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration". This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.

What is the current status of trial NCT06690333?

This trial is currently recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2024-11-05. Estimated completion is 2026-12.

What conditions does trial NCT06690333 study?

This clinical trial studies the following conditions: Pacemaker Implantation, AV Node Disease.

What interventions are being tested in trial NCT06690333?

The interventions under investigation include: Pacemaker (DEVICE).

Who is sponsoring clinical trial NCT06690333?

This trial is sponsored by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06690333 being conducted?

This trial has 2 study locations across Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06690333's enrollment target sits among peer trials

75 1069th of 2000 higher than 919 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 NCT06690333, the US trial registry maintained by the National Library of Medicine. NCT06690333 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.