Ventricular TachycardiaVTeeeNCT01767220
Endo- and Epicardial vs. Endocardial Ablation of Ventricular Tachycardia in Patients With Cardiac Disease
A study testing Strategy 1 - endocardial ablation and Strategy 2 - endocardial and epicardial ablation in people with Ventricular Tachycardia, run by University of Rostock at 1 site in Germany.
Trial summary
A significant portion of patients with cardiac diseases like coronary artery disease (CAD), dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC) develops ventricular tachycardia (VT). The standard ablation procedure is carried out from endocardial only. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Strategy 1 - endocardial ablation and Strategy 2 - endocardial and epicardial ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Nov 2014
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- structural heart disease (CAD, DCM, ARVC)
- ICD already implanted
- documented ventricular tachycardia
- patient is able to give informed consent
- VT ablation because of vital indication
Who cannot join
- VT without structural cardiac disease
- VT not documented
- patient is not able to give informed consent
- contraindication for pericardial puncture
- mechanical aortic valve
- pacemaker or ICD with an epicardial lead
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Rostock
Rostock, Mecklenburg-Vorpommern, 18057
Joerg Lauschke, Dr. med., 0049-381-494-7797, joerg.lauschke@uni-rostock.de
Dietmar Baensch, Prof. Dr.
About this study
Official title: Primary Endo- and Epicardial vs. Endocardial Ablation of Sustained Ventricular Tachycardia in Patients With Underlying Cardiac Disease (VTeee)
A significant portion of patients with cardiac diseases like coronary artery disease (CAD), dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC) develops ventricular tachycardia (VT). The standard ablation procedure is carried out from endocardial only. In 30% of patients treated this way a successful ablation is not possible. In these cases the scar areas are mostly located in the outer layer of the myocardium. Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle. In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation.
This prospective randomized trial compares the standard ablation procedure (endocardial ablation only) with a new strategy. This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial. The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation only.
Read more
40 patients will be enrolled. They will be randomized 1:1 in the study arms "strategy 1" which is standard endocardial ablation and "strategy 2" which is endo- and epicardial ablation.
At least 12 months are planned for enrollment. The study is closed if the patient last enrolled has completed the 12-months-follow up. Follow up visits are scheduled 3, 6 and 12 months after the ablation procedure. Recurrence of VT is monitored by ICD (implanted cardioverter defibrillator) interrogation.
Both ablation strategies are well established and conducted with standard equipment. The methodology of this study does not contain any experimental approaches. The standard insurance coverage of the hospital is guaranteed for all enrolled patients.
Read the detailed description
A significant portion of patients with cardiac diseases like coronary artery disease (CAD), dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC) develops ventricular tachycardia (VT). These arrhythmia often causes symptoms like dizziness, shortness of breath, angina or even cardiogenic shock. Large trials showed that VTs are associated with a 3.4 to 5fold increase in mortality even if each episode was successfully terminated by an ICD. Initially most patients are treated with antiarrhythmics. If these drugs are ineffective or not tolerated because of side effects catheter ablation (obliteration of cardiac tissue by radiofrequency) is the only alternative therapy.
The mechanism of most VTs are reentry circuits which are typically found in areas of scar in the left or right chamber. These scar areas may be located in the inner layer of the myocardium (endocardial), in the outer layer (epicardial) or in all layers of the heart muscle (transmural). The standard ablation procedure is carried out from endocardial only. This means catheters introduced through the femoral veins or arteries are placed in the right or left ventricle. In 30% of patients treated this way a successful ablation is not possible. In these cases the scar areas are mostly located in the outer layer of the myocardium. Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle. In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation.
This prospective randomized trial compares the standard ablation procedure (endocardial ablation only) with a new strategy. This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial. The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation only.
Patients are eligible if they show documented VT on the basis of an underlying cardiac disease and a therapy with antiarrhythmics was ineffective or not tolerated. In terms of this study cardiac disease means CAD, DCM and ARVC. All patients have to be treated with an ICD. Patients are not eligible if VT is not documented, if there is no structural heart disease, if they have a mechanical aortic valve or a pacemaker/ICD with epicardial leads implanted or if a pericardial puncture must not be done.
40 patients will be enrolled. They will be randomized 1:1 in the study arms "strategy 1" which is standard endocardial ablation and "strategy 2" which is endo- and epicardial ablation.
In case of strategy 1 ablation catheters are placed in the right, left or both ventricles through the femoral veins/arteries. VT is induced by programmed stimulation and then analysed. By means of 3D-electroanatomical mapping the endocardial surface is reconstructed. The scar areas are marked and in a second step obliterated.
In case of strategy 2 in addition to the endocardial access via femoral veins/arteries a pericardial puncture is performed to get access to the epicardial space. This allows placement of ablation catheters on the epicardial surface of the heart. VT is induced and analysed from endo- and epicardial. In addition to strategy 1 a 3D-reconstruction of the epicardial surface is made and scar areas are marked like from endocardial. In a first step endocardial ablation is performed. Thereafter changes in epicardial scar areas are analyzed. In case of still inducible VT after endocardial ablation epicardial ablation is performed as a second step. The success of strategy 1 and 2 is always checked by programmed ventricular stimulation.
At least 12 months are planned for enrollment. The study is closed if the patient last enrolled has completed the 12-months-follow up. Follow up visits are scheduled at 3, 6 and 12 months after the ablation procedure. Recurrence of VT is monitored by ICD interrogation.
Both ablation strategies are well established and conducted with standard equipment. The methodology of this study does not contain any experimental approaches. The standard insurance coverage of the hospital is guaranteed for all enrolled patients.
- Conditions
- Ventricular Tachycardia
- Being tested
- Strategy 1 - endocardial ablation, Strategy 2 - endocardial and epicardial ablation
- Keywords
- ventricular tachycardia, endocardial ablation, epicardial ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy 1 - endocardial ablationProcedure or surgery
VT substrate mapping and VT ablation are done only from endocardial. Therefore the catheters are introduced through the femoral veins/arteries. For mapping and ablation a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used.
Strategy 2 - endocardial and epicardial ablationProcedure or surgery
VT substrate mapping and VT ablation are done from endocardial and epicardial. Therefore the catheters are introduced through the femoral veins/arteries and into the pericardial space via a pericardial puncture. After endocardial and epicardial mapping, ablation is done from endocardial. In case of an ineffective endocardial ablation and an epicardial substrate an epicardial ablation is done. For mapping and ablation from endo- and epicardial a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Strategy 1- endocardial ablation | Active comparator | VT substrate mapping and VT ablation are done only from endocardial. Receives: Procedure: Strategy 1 - endocardial ablation |
| Strategy 2 - endocardial and epicardial ablation | Active comparator | VT substrate mapping and ablation are done from endocardial and epicardial. Receives: Procedure: Strategy 2 - endocardial and epicardial ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of any VT
Recurrence of any VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: 3, 6 and 12 months after the date of the VT ablation procedure. In case of emergency (e.g. incessant VT, VT storm, resuscitation due to ventricular fibrillation) an additional ICD interrogation is done at admission to hospital.
Measured: up to 12 months after the date of VT ablation
Secondary outcomes (3)
percentage of VT substrates which can only be abolished by epicardial ablation
This secondary outcome measure is evaluated only once during the hospital stay at the date of the VT ablation procedure. The average time of hospital stay for VT ablation is estimated to 3 to 5 days.
Measured: date of VT ablation - up to 3 to 5 days
12 lead ECG features typical for epicardial VT substrates
This secondary outcome measure is evaluated only once during the hospital stay at the date of the VT ablation procedure. The average time of hospital stay for VT ablation is estimated to 3 to 5 days.
Measured: date of VT ablation up to 3 to 5 days
percentage of epicardial VT substrates referred to the underlying cardiac disease
This secondary outcome measure is evaluated only once during the hospital stay at the date of the VT ablation procedure. The average time of hospital stay for VT ablation is estimated to 3 to 5 days.
Measured: date of VT ablation - up to 3 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietmar Baensch, University of Rostock
- Investigators
- Dietmar Baensch, Prof. Dr., Principal investigator, University Hospital of Rostock, Dept. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767220
- Sponsor's protocol ID
- A 2012-0125
- Acronym
- VTeee
- Status last verified
- Jan 2013
- First submitted
- 7 Jan 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Endo- and Epicardial vs. Endocardial Ablation of Sustained Ventricular Tachycardia in Patients With Underlying Cardiac Disease (VTeee)
- ClinicalTrials.gov ID
- NCT01767220
- Acronym / sponsor ID
- VTeee / A 2012-0125
- Conditions
- Ventricular Tachycardia
- Keywords
- ventricular tachycardia, endocardial ablation, epicardial ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 14 Jan 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.
A significant portion of patients with cardiac diseases like coronary artery disease (CAD), dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC) develops ventricular tachycardia (VT). The standard ablation procedure is carried out from endocardial only. In 30% of patients treated this way a successful ablation is not possible. In these cases the scar areas are mostly located in the outer layer of the myocardium. Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle. In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation.
This prospective randomized trial compares the standard ablation procedure (endocardial ablation only) with a new strategy. This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial. The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation only.
40 patients will be enrolled. They will be randomized 1:1 in the study arms "strategy 1" which is standard endocardial ablation and "strategy 2" which is endo- and epicardial ablation.
At least 12 months are planned for enrollment. The study is closed if the patient last enrolled has completed the 12-months-follow up. Follow up visits are scheduled 3, 6 and 12 months after the ablation procedure. Recurrence of VT is monitored by ICD (implanted cardioverter defibrillator) interrogation.
Both ablation strategies are well established and conducted with standard equipment. The methodology of this study does not contain any experimental approaches. The standard insurance coverage of the hospital is guaranteed for all enrolled patients.
Detailed description
A significant portion of patients with cardiac diseases like coronary artery disease (CAD), dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC) develops ventricular tachycardia (VT). These arrhythmia often causes symptoms like dizziness, shortness of breath, angina or even cardiogenic shock. Large trials showed that VTs are associated with a 3.4 to 5fold increase in mortality even if each episode was successfully terminated by an ICD. Initially most patients are treated with antiarrhythmics. If these drugs are ineffective or not tolerated because of side effects catheter ablation (obliteration of cardiac tissue by radiofrequency) is the only alternative therapy.
The mechanism of most VTs are reentry circuits which are typically found in areas of scar in the left or right chamber. These scar areas may be located in the inner layer of the myocardium (endocardial), in the outer layer (epicardial) or in all layers of the heart muscle (transmural). The standard ablation procedure is carried out from endocardial only. This means catheters introduced through the femoral veins or arteries are placed in the right or left ventricle. In 30% of patients treated this way a successful ablation is not possible. In these cases the scar areas are mostly located in the outer layer of the myocardium. Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle. In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation.
This prospective randomized trial compares the standard ablation procedure (endocardial ablation only) with a new strategy. This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial. The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation only.
Patients are eligible if they show documented VT on the basis of an underlying cardiac disease and a therapy with antiarrhythmics was ineffective or not tolerated. In terms of this study cardiac disease means CAD, DCM and ARVC. All patients have to be treated with an ICD. Patients are not eligible if VT is not documented, if there is no structural heart disease, if they have a mechanical aortic valve or a pacemaker/ICD with epicardial leads implanted or if a pericardial puncture must not be done.
40 patients will be enrolled. They will be randomized 1:1 in the study arms "strategy 1" which is standard endocardial ablation and "strategy 2" which is endo- and epicardial ablation.
In case of strategy 1 ablation catheters are placed in the right, left or both ventricles through the femoral veins/arteries. VT is induced by programmed stimulation and then analysed. By means of 3D-electroanatomical mapping the endocardial surface is reconstructed. The scar areas are marked and in a second step obliterated.
In case of strategy 2 in addition to the endocardial access via femoral veins/arteries a pericardial puncture is performed to get access to the epicardial space. This allows placement of ablation catheters on the epicardial surface of the heart. VT is induced and analysed from endo- and epicardial. In addition to strategy 1 a 3D-reconstruction of the epicardial surface is made and scar areas are marked like from endocardial. In a first step endocardial ablation is performed. Thereafter changes in epicardial scar areas are analyzed. In case of still inducible VT after endocardial ablation epicardial ablation is performed as a second step. The success of strategy 1 and 2 is always checked by programmed ventricular stimulation.
At least 12 months are planned for enrollment. The study is closed if the patient last enrolled has completed the 12-months-follow up. Follow up visits are scheduled at 3, 6 and 12 months after the ablation procedure. Recurrence of VT is monitored by ICD interrogation.
Both ablation strategies are well established and conducted with standard equipment. The methodology of this study does not contain any experimental approaches. The standard insurance coverage of the hospital is guaranteed for all enrolled patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy 1- endocardial ablation | Active comparator | Procedure: Strategy 1 - endocardial ablationVT substrate mapping and VT ablation are done only from endocardial. |
| Strategy 2 - endocardial and epicardial ablation | Active comparator | Procedure: Strategy 2 - endocardial and epicardial ablationVT substrate mapping and ablation are done from endocardial and epicardial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- structural heart disease (CAD, DCM, ARVC)
- ICD already implanted
- documented ventricular tachycardia
- patient is able to give informed consent
- VT ablation because of vital indication
Key exclusion criteria (6 listed)
- VT without structural cardiac disease
- VT not documented
- patient is not able to give informed consent
- contraindication for pericardial puncture
- mechanical aortic valve
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 |
|---|---|---|
| Strategy 1 - endocardial ablationVT substrate mapping and VT ablation are done only from endocardial. Therefore the catheters are introduced through the femoral veins/arteries. For mapping and ablation a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used. | Procedure or surgery | Strategy 1- endocardial ablation |
| Strategy 2 - endocardial and epicardial ablationVT substrate mapping and VT ablation are done from endocardial and epicardial. Therefore the catheters are introduced through the femoral veins/arteries and into the pericardial space via a pericardial puncture. After endocardial and epicardial mapping, ablation is done from endocardial. In case of an ineffective endocardial ablation and an epicardial substrate an epicardial ablation is done. For mapping and ablation from endo- and epicardial a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used. | Procedure or surgery | Strategy 2 - endocardial and epicardial ablation |
Primary outcome
recurrence of any VT
Time frame: up to 12 months after the date of VT ablation
Recurrence of any VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: 3, 6 and 12 months after the date of the VT ablation procedure. In case of emergency (e.g. incessant VT, VT storm, resuscitation due to ventricular fibrillation) an additional ICD interrogation is done at admission to hospital.
3 secondary outcomes
percentage of VT substrates which can only be abolished by epicardial ablation
Time frame: date of VT ablation - up to 3 to 5 days
12 lead ECG features typical for epicardial VT substrates
Time frame: date of VT ablation up to 3 to 5 days
percentage of epicardial VT substrates referred to the underlying cardiac disease
Time frame: date of VT ablation - up to 3 to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
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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.
Dietmar Baensch, Prof. Dr. principal investigator
University Hospital of Rostock, Dept. of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy 1 - endocardial ablation and Strategy 2 - endocardial and epicardial ablation in people with Ventricular Tachycardia, run by University of Rostock 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 5 inclusion and 6 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 30 Jan 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joerg Lauschke, Dr. (0049-381-494-7797, joerg.lauschke@uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of any VT (time frame: up to 12 months after the date of VT ablation). 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 30 Jan 2014.