Gravitational Arrhythmogenesis Can the Often-heard Sympto... | NCT05347953

Studies
Gravitational Arrhythmogenesis Can the Often-heard Symptom of Body Position Dependent Palpitations be Proven

NCT05347953

Sponsor

Catharina Ziekenhuis Eindhoven

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cardiac Complexes, Premature
Atrial Fibrillation

Interventions

Single night downgraded home polygraphy

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Estimated

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Apr 21, 2022

First Submission Date that Met QC Criteria

Apr 25, 2022

First Posted Date

Apr 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2022

Last Update Posted Date

Apr 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maarten van den Broek, JLPM van den Broek, MD, Catharina Ziekenhuis EindhovenPrincipal Investigator

Lead Sponsor

Catharina Ziekenhuis EindhovenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to assess the relationship between body position and the occurrence of either atrial or ventricular premature beats and more complex arrhythmia

Detailed Description

Rationale: Palpitations in a certain body position is an often-heard symptom, although there is currently no direct evidence that links body position with arrhythmia. The hypothesis is that arrhythmia is more prevalent in the specific body position that the patient reports to be arrhythmogenic.

Objective: The objective of this study is to assess the relationship between body position and the occurrence of either atrial or ventricular premature beats and more complex arrhythmia (AT, atrial fibrillation (AF), VT) in a population that have a self-reported preferential body position for symptoms.

Study design: Single cohort study. Subjects are recruited from the outpatient clinic. First, they will fill in a short questionnaire regarding their symptoms; second, they will be outfitted with a downgraded polygraphy device, that only monitors body position, and single and/or multi lead ECG for 24 hours. The acquired data will be analyzed at the Catharina Hospital and the Eindhoven University of Technology.

Study population: Outpatients with palpitations and a self-reported higher prevalence in a certain body position that have an indication to undergo Holter monitoring, independent of any previous diagnosis.

Main study parameters/endpoints: The frequency of ectopic beats or onset of complex arrhythmia (n per minute) in the body position that the patient has reported as arrhythmogenic, compared to arrhythmia rate in the other body positions, corrected for time spent per body position.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm		Patients with self-reported symptoms of positional dependent palpitations	Device: Single night downgraded home polygraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single night downgraded home polygraphy	Device	All patients will be outfitted with the ambulatory downgraded polygraphy device (Nox A1, Nox Medical Global, Reykjavik) for 24 hour monitoring. The data exported by the polygraphy device is in European Data Format and will be filtered and annotated using custom MATLAB-software.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arrhythmia per body position	The frequency of ectopic beats or onset of complex arrhythmia (n per minute) in the body position that the patient has reported as arrhythmogenic, compared to arrhythmia rate in the other body positions, corrected for time spent per body position.	1 night recording

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Palpitations, spontaneously described to occur either predominantly or solely in a certain body position (upright, prone, supine, left or right lateral decubital position).
Ability to provide informed consent

Exclusion Criteria:

There are no exclusion criteria for this study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study will be conducted in outpatients that present with palpitations and a spontaneous self-reported higher prevalence in a certain body position.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JLPM van den Broek	Contact	+31402397000		maarten.vd.broek@catharinaziekenhuis.nl

Overall Officials

Name	Affiliation	Role
JLPM van den Broek	Catharina Ziekenhuis Eindhoven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catharina Ziekenhuis		Eindhoven		5623EJ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized data can be available upon reasonable request by non-commercial fellow researchers

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

1-20 years after publication of study

Access Criteria

non-commercial

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005117	Cardiac Complexes, Premature
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

Browse Leaves

Not provided

Browse Branches

Not provided