NCT04320849 (HUCS) is a clinical trial in Pacemaker Malfunction, sponsored by Duke University.

Who is sponsoring NCT04320849?

NCT04320849 is sponsored by Duke University.

What condition does NCT04320849 study?

NCT04320849 studies Pacemaker Malfunction.

Is NCT04320849 still recruiting?

NCT04320849 is currently completed. Last updated 19 January 2024.

Are results published for NCT04320849?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-01-19 · How we verify

NCT04320849: HUCS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Human Use Condition Study- Evaluation of Implanted Leads in Humans

Completed Results posted Last updated 19 January 2024

What this trial tests

trial in Pacemaker Malfunction in 117 participants. Completed in 23 May 2022.

Timeline

1 June 2021

Primary endpoint
30 April 2022

23 May 2022

Quick facts

Lead sponsor	Duke University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	117
Start date	1 June 2021
Primary completion	30 April 2022
Estimated completion	23 May 2022
Sites	5 locations across United States

Conditions studied

Pacemaker Malfunction — all drugs for Pacemaker Malfunction →

Sponsor

Duke University

Who can join

18 and older, any sex, with Pacemaker Malfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements Primary · Approximately 1 month

Measure dynamic in vivo curvature of RV pacing and defibrillator leads in the extravenous and intracardiac anatomy \*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the extravenous region will be determined during specified arm movements. The relationship between lead stiffness and curvature will be evaluated.

Group	Value	95% CI
Consented Patients With RV Pacing Leads and Defibrillation Leads	109

Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Intracardiac Region Determined During Two or More Cardiac Cycles Primary · Approximately 1 month

Measure the relationship between lead bending stiffness and in vivo curvature \*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the intracardiac region will be determined during two or more cardiac cycles. The relationship between lead stiffness and curvature will be evaluated.

Group	Value	95% CI
Consented Patients With RV Pacing Leads and Defibrillation Leads	109

Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements Primary · Approximately 1 month

Assess the relationship between subject and implant variables and lead curvature \*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the connector region were determined during specified arm movements. The relationship between lead stiffness and curvature was evaluated.

Group	Value	95% CI
Consented Patients With RV Pacing Leads and Defibrillation Leads	109

Sponsor's own description

The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and motion of your previously implanted lead changes in the body.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04320849 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 19 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04320849.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing