NCT05105516

Brief Summary

Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and effect of ablation and comparison between different sites of ablation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

October 25, 2021

Last Update Submit

June 1, 2022

Conditions

Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • • Detection of early cardiac dysfunction in patients with idiopathic frequent monomorphic PVCs .

    • Assessment of cardiac function in patients with idiopathic frequent monomorphic PVCs post - ablation and patients on medical treatment

    Baseline

Study Arms (1)

Ablation

OTHER

Comparison between different sites of ablation

Procedure: Ablation

Interventions

AblationPROCEDURE

Ablation of ectopic foci causing PVCs

Ablation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients of sample size admitted to the cardiology department of Assiut university hospital for ablation of idiopathic frequent monomorphic PVCs

You may not qualify if:

  • Patients with well-known factors of cardiac dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, severe valvular disease, complete heart block, and previous CABG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (2)

  • Latchamsetty R, Bogun F. Premature Ventricular Complex-Induced Cardiomyopathy. JACC Clin Electrophysiol. 2019 May;5(5):537-550. doi: 10.1016/j.jacep.2019.03.013.

    PMID: 31122375BACKGROUND

  • Sharma E, Arunachalam K, Di M, Chu A, Maan A. PVCs, PVC-Induced Cardiomyopathy, and the Role of Catheter Ablation. Crit Pathw Cardiol. 2017 Jun;16(2):76-80. doi: 10.1097/HPC.0000000000000106.

    PMID: 28509708BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Mohammed Usama

CONTACT

+201013001256mohammedusama502@gmail.com

Salah Atta, prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MTony

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 3, 2021

Study Start

November 1, 2022

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

June 3, 2022

Record last verified: 2022-06

Locations

EG(1)