NCT04229589

Brief Summary

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

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
1,364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

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

Study Start

First participant enrolled

January 1, 2010

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

December 1, 2019

Enrollment Period

10.2 years

First QC Date

January 12, 2020

Last Update Submit

January 12, 2020

Conditions

Syncope

Keywords

Syncope, pacemaker, bradyarrhythmias

Outcome Measures

Primary Outcomes (1)

  • Syncopal relapse

    First syncopal relapse after pacemaker implantation

    march 2020

Study Arms (1)

Study population

Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope

Other: Clinic follow-up

Interventions

Clinic follow-upOTHER

Patients are regularly evaluated to asses the occurrence of syncopal relapses

Study population

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope (proven or presumed) according current guidelines

You may qualify if:

  • patients undergoing pacemaker implantation for bradyarrhythmic syncope

You may not qualify if:

  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

"Card. G. Panico" Hospital

Tricase, Lecce, 73039, Italy

Location

Federico Guerra

Ancona, Italy

Location

Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

AO Pugliese-Ciaccio

Catanzaro, 88100, Italy

Location

Monaldi Hospital

Napoli, Italy

Location

AOU "Maggiore della Carità"

Novara, 28100, Italy

Location

Dell'Era Gabriele

Novara, Italy

Location

MeSH Terms

Conditions

SyncopeBradycardia

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2020

First Posted

January 18, 2020

Study Start

January 1, 2010

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

January 18, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(7)