Ventricular TachycardiaAVAINCT00832975

AVAI: Atrial Ventricular Arrythmia Incidence

An observational study of Ventricular Tachycardia and Atrial Fibrillation, run by Abbott Medical Devices at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventricular Tachycardia, Atrial Fibrillation
How many people: 157 participants
Where: 2 sitesSpain
Study dates: Dec 2008to Dec 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients implanted with a St. Jude Medical ICD

Who may be able to join

Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
Patient has signed the study specific Informed consent document.
Patient is older than 18 years of age

Who cannot join

Patient has a permanent Atrial Fibrillation
Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
Patient requires cardiac resynchronization
Patient has Brugada Syndrome
Patient has long QT Syndrome

Show all 9Show fewer

Patient has a device replacement;
Patient is pregnant or nursing
Patient is unable to attend the follow-up visits

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Hospital Universitario Puerta de Hierro
Madrid, 28222
Hospital Clínico Universitario Virgen de la Victoria
Málaga

Other trials in Spain

About this study

Official title: Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .

The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

Read the detailed description

The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.

Conditions: Ventricular Tachycardia, Atrial Fibrillation
Medical subject headings: Tachycardia, Ventricular, Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)
Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec
Measured: 24 months

Secondary outcomes (1)

Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Dec 2013

First posted30 Jan 2009 (estimated)
Study startDec 2008
Primary completionFeb 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
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: Case only
Time perspective: Prospective
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00832975
Sponsor's protocol ID: CR08003ES
Acronym: AVAI
Status last verified: Feb 2019
First submitted: 29 Jan 2009
Last updated: 21 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia

All Ventricular Tachycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .
ClinicalTrials.gov ID: NCT00832975
Acronym / sponsor ID: AVAI / CR08003ES
Conditions: Ventricular Tachycardia, Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Feb 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 30 Jan 2009 (estimated)
Results: Posted 3 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients implanted with a St. Jude Medical ICD

Key inclusion criteria (3 listed)

Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
Patient has signed the study specific Informed consent document.
Patient is older than 18 years of age

Key exclusion criteria (9 listed)

Patient has a permanent Atrial Fibrillation
Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
Patient requires cardiac resynchronization
Patient has Brugada Syndrome

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

Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)
Time frame: 24 months
Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec

1 secondary outcome

Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure
Time frame: 24 months

Results and safety

Results posted to the registry on 3 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
St Jude Medical ICD/CRT-D	157	118

Primary outcome: Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)

Time frame: 24 months. Number. Unit: Episodes

Measure	St Jude Medical ICD/CRT-D n = 157
Device Slow VT Episodes	3778
Internal Investigator Slow VT Episodes	112
External investigator Slow VT Episodes	68
Device AF>30sec Episodes	308
Internal Investigator AF>30sec Episodes	1900
External Investigator AF>30sec Episodes	2864

Population analysed: 157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
St Jude Medical ICD/CRT-D	67 of 157 (42.7%)	20 of 157 (12.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ventricular Tachycardia

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia

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.

Ignacio Fernández Lozano, PhD. principal investigator

Hospital Universitario Puerta de Hierro

Javier Alzueta, PhD principal investigator

Hospital Clinico Universitario Virgen de la Victoria

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Tachycardia and Atrial Fibrillation, run by Abbott Medical Devices at 2 sites in Spain.

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 3 inclusion and 9 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: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Yes. Results are posted in the registry (first posted 3 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00832975.

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 21 Feb 2019.