Ventricular TachyarrhythmiasNCT01906775
Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia
An observational study of Ventricular Tachyarrhythmias and ICD Shock Therapy, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can increase mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachyarrhythmias, ICD Shock Therapy, ICD Shock Burden
- What is being tested?
- Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level
- How many people
- 550 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2003to May 2013
- 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: Patients having an implanted ICD for secondary prevention of ventricular tachyarrhythmias. Patients are routinely under follow-up for device interrogation in our outpatient device department. Patients with identified pacemaker-induced ventricular tachycardia were selected and after two or more episodes of VT, the ventricular back-up pacing was reprogrammed to a sub-threshold level.
Who may be able to join
- age > 18 years
- implanted ICD
- occurrence of pacemaker-induced VT
Who cannot join
- documentation of pause-related syncope
- AV block
- sick-sinus syndrome
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology
Mainz, D-55131
About this study
Official title: Sub-threshold Ventricular Back-up Pacing to Prevent Pacemaker-induced Ventricular Tachycardia
Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can increase mortality. This study aimed to determine the role of back-up pacing-induced VT (PIT) to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing by programming the pacing output to a sub-threshold level for ineffective pacing.
- Being tested
- Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level
- Keywords
- ICD, ventricular tachyarrhythmia, shock, sub-threshold pacing
- Medical subject headings
- Tachycardia, Ventricular, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programming the pacemaker output for ventricular back-up pacing to a sub-threshold levelOther
Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output
| Study group | Role | What they receive |
|---|---|---|
| Patients with PIT | Identification of patients with pacemaker-induced ventricular tachycardias Receives: Other: Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of VT requiring ICD shock
Patients were followed-up for the occurrence of ventricular tachycardia requiring ICD shock therapy
Measured: 48 months follow-up
Secondary outcomes (1)
Type of arrhythmia / Number of arrhythmia
Analysis of the number and the types of recurrent arrhythmias requiring ICD shock termination
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJun 2003
- Primary completionSep 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachyarrhythmiasStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Rostock, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906775
- Sponsor's protocol ID
- PIT in ICD patients
- Status last verified
- Jul 2013
- First submitted
- 20 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Theis C, Mollnau H, Sonnenschein S, Konrad T, Himmrich E, Bock K, Schulz E, Kampfner D, Gerhardt S, Quesada Ocete B, Munzel T, Rostock T. Reduction of ICD shock burden by eliminating back-up pacing induced ventricular tachyarrhythmias. J Cardiovasc Electrophysiol. 2014 Aug;25(8):889-895. doi: 10.1111/jce.12418. Epub 2014 May 2.
PubMed 24654876
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-threshold Ventricular Back-up Pacing to Prevent Pacemaker-induced Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT01906775
- Acronym / sponsor ID
- PIT in ICD patients
- Keywords
- ICD, ventricular tachyarrhythmia, shock, sub-threshold pacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- 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.
Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can increase mortality. This study aimed to determine the role of back-up pacing-induced VT (PIT) to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing by programming the pacing output to a sub-threshold level for ineffective pacing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PIT | – | Other: Programming the pacemaker output for ventricular back-up pacing to a sub-threshold levelIdentification of patients with pacemaker-induced ventricular tachycardias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having an implanted ICD for secondary prevention of ventricular tachyarrhythmias. Patients are routinely under follow-up for device interrogation in our outpatient device department. Patients with identified pacemaker-induced ventricular tachycardia were selected and after two or more episodes of VT, the ventricular back-up pacing was reprogrammed to a sub-threshold level.
Key inclusion criteria (3 listed)
- age > 18 years
- implanted ICD
- occurrence of pacemaker-induced VT
Key exclusion criteria (4 listed)
- documentation of pause-related syncope
- AV block
- sick-sinus syndrome
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programming the pacemaker output for ventricular back-up pacing to a sub-threshold levelProgramming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output | Other | Patients with PIT |
Primary outcome
Occurrence of VT requiring ICD shock
Time frame: 48 months follow-up
Patients were followed-up for the occurrence of ventricular tachycardia requiring ICD shock therapy
1 secondary outcome
Type of arrhythmia / Number of arrhythmia
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
- Derived from this study: PubMed 24654876Theis C, Mollnau H, Sonnenschein S, Konrad T, Himmrich E, Bock K, Schulz E, Kampfner D, Gerhardt S, Quesada Ocete B, Munzel T, Rostock T. Reduction of ICD shock burden by eliminating back-up pacing induced ventricular tachyarrhythmias. J Cardiovasc Electrophysiol. 2014 Aug;25(8):889-895. doi: 10.1111/jce.12418. Epub 2014 May 2.
Related trials for Ventricular Tachyarrhythmias
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ventricular Tachyarrhythmias and ICD Shock Therapy, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 4 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 24 Jul 2013. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of VT requiring ICD shock (time frame: 48 months follow-up). 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 NCT01906775, which also lists 1 linked publication.
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 24 Jul 2013.