Heart Failure，CongestiveSEASIDENCT03813589
Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients
An observational study of Heart Failure，Congestive and Atrial Arrhythmia, run by San Leonardo Hospital at 1 site in Italy.
Trial summary
The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure，Congestive, Atrial Arrhythmia
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2019to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients implanted with dual chamber pacemaker able to automatically detect congestive heart failure and atrial tachyarrhythmias events.
Who may be able to join
- Recent implant of DR pacemaker according to current guidelines
- Sinus Rhythm at enrollment
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: State of congEstive heArt Failure Before the onSet of atrIal Tachyarrhythmias Detected by Implanted devicE in Pacemaker Patients (SEASIDE)
The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device.
- Conditions
- Heart Failure，Congestive, Atrial Arrhythmia
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PMK patients | Patients already implanted with double chamber pacemaker able to detect automatically congestive heart failure and collect atrial events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate relationship between atrial tachyarrhythmias and congestive heart failure
Relationship between thoracic impedance variations and atrial events collected by device
Measured: twelve months
Secondary outcomes (1)
Detect optimal device programming
Identify useful index congestion trigger value
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start19 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Leonardo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Russo, San Leonardo Hospital
- Investigators
- Giovanni Russo, MD, Principal investigator, San Leonardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813589
- Sponsor's protocol ID
- SS001
- Acronym
- SEASIDE
- Status last verified
- Mar 2021
- First submitted
- 20 Jan 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State of congEstive heArt Failure Before the onSet of atrIal Tachyarrhythmias Detected by Implanted devicE in Pacemaker Patients (SEASIDE)
- ClinicalTrials.gov ID
- NCT03813589
- Acronym / sponsor ID
- SEASIDE / SS001
- Conditions
- Heart Failure，Congestive, Atrial Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- San Leonardo HospitalUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMK patients | – | –Patients already implanted with double chamber pacemaker able to detect automatically congestive heart failure and collect atrial events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients implanted with dual chamber pacemaker able to automatically detect congestive heart failure and atrial tachyarrhythmias events.
Key inclusion criteria (2 listed)
- Recent implant of DR pacemaker according to current guidelines
- Sinus Rhythm at enrollment
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate relationship between atrial tachyarrhythmias and congestive heart failure
Time frame: twelve months
Relationship between thoracic impedance variations and atrial events collected by device
1 secondary outcome
Detect optimal device programming
Time frame: twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Russo, MD principal investigator
San Leonardo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure，Congestive and Atrial Arrhythmia, run by San Leonardo Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate relationship between atrial tachyarrhythmias and congestive heart failure (time frame: twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.