Ventricular TachycardiaARDEVATNCT02071511
Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
A study testing Ablation of ventricular arrhythmias and Ablation of ventricular arrhythmias + renal denervation in people with Ventricular Tachycardia and Cardiomyopathy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Study hypothesis: With optimal medical therapy and repeated ablations, an additional renal denervation may have protective effects in terms of vegetative intrinsic activity and lead to a significant reduction in VT Burdens. Study design: Multicenter, randomized, prospective, single-blind clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Cardiomyopathy
- What is being tested?
- Ablation of ventricular arrhythmias and Ablation of ventricular arrhythmias + renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Ischemic cardiomyopathy
- NYHA II-III
- Recurrent ventricular tachycardia, ICD interventions (shock or ATP)
- Obtained written informed consent
Who cannot join
- Age <18 years
- Previous VT ablation
- NYHA IV
- Cardiopulmonary decompensation within the last 4 weeks
- Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
- History of hemorrhagic diathesis or other coagulopathies
Show all 11Show fewer
- Contraindication for oral anticoagulation
- Hyper- or hypothyroidism
- Drug or chronic alcohol abuse
- Has any condition that would make participation not be in the best interest of the subject
- Incompliance
Trial locations and contacts
1 site in 1 country.
About this study
Study hypothesis:
With optimal medical therapy and repeated ablations, an additional renal denervation may have protective effects in terms of vegetative intrinsic activity and lead to a significant reduction in VT Burdens.
Study design:
Multicenter, randomized, prospective, single-blind clinical trial.
Read the detailed description
Study protocol:
Catheter ablation of ventricular tachycardia versus combined catheter ablation of ventricular tachycardia and renal denervation.
A total of 50 patients with ventricular tachycardia treated with ICD shocks or ATP will be enrolled in this study. The randomization in the study is done before ablation.
For the ablation, an arterial access is required in both groups. During a 30 minutes waiting time which will apply to both groups, renal denervation will be performed.
In this period of time operators and staff will be blinded for the procedure, thereby they won't know if the patients will receive a renal denervation, in that way the investigators are avoiding a bias of future treatment of the patients.
Follow up and repeat procedures:
All Patients will be followed for a period of 3, 6, 9, 12 and 18 months after the procedure.
Regular visits are done in the investigators office. The visit will include ICD Interrogation, VT documentation in ICD Holter, 24-hour Holter ECG or Tele-ECGs, echocardiography.
Re- VT ablations are allowed at any time. In case of renal artery stenosis, denervation will not be performed. Drug therapy can be continued.
- Conditions
- Ventricular Tachycardia, Cardiomyopathy
- Being tested
- Ablation of ventricular arrhythmias, Ablation of ventricular arrhythmias + renal denervation
- Medical subject headings
- Tachycardia, Ventricular, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation of ventricular arrhythmiasProcedure or surgery
control group: Ablation of ventricular arrhythmias
Ablation of ventricular arrhythmias + renal denervationProcedure or surgery
Intervention group: Ablation of ventricular arrhythmias + renal denervation
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Ablation of ventricular arrhythmias Receives: Procedure: Ablation of ventricular arrhythmias |
| intervention group | Sham comparator | Ablation of ventricular arrhythmias + renal denervation Receives: Procedure: Ablation of ventricular arrhythmias + renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up
Number of Patients with adverse events such as recurrens of Ventricular
Measured: 24 months
Secondary outcomes (2)
Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up
Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up
Measured: 24 months
Number of periprocedural complications
Number of periprocedural complications
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionAug 2016
Why it stopped: The Sponsor appreciate the devastating impact that the results of the SYMPLICITY HTN 3 trial had on research progress for renal denervation. Based on the lack of recent progress, it is no longer practical to maintain the agreement.
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.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Stephan Willems, MD, Principal investigator, ASKLEPIOS St. Georg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071511
- Sponsor's protocol ID
- PV4286
- Acronym
- ARDEVAT
- Status last verified
- Sep 2022
- First submitted
- 10 Feb 2014
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We at Medtronic certainly appreciate the devastating impact that the results of the SYMPLICITY HTN 3 trial had on research progress for renal denervation, including your trial. Therefore, based on the lack of recent progress, it is no longer practical to maintain our agreement and we are hereby terminating our support for the trial.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
- ClinicalTrials.gov ID
- NCT02071511
- Acronym / sponsor ID
- ARDEVAT / PV4286
- Conditions
- Ventricular Tachycardia, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor appreciate the devastating impact that the results of the SYMPLICITY HTN 3 trial had on research progress for renal denervation. Based on the lack of recent progress, it is no longer practical to maintain the agreement.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Feb 2014 (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.
Study hypothesis:
With optimal medical therapy and repeated ablations, an additional renal denervation may have protective effects in terms of vegetative intrinsic activity and lead to a significant reduction in VT Burdens.
Study design:
Multicenter, randomized, prospective, single-blind clinical trial.
Detailed description
Study protocol:
Catheter ablation of ventricular tachycardia versus combined catheter ablation of ventricular tachycardia and renal denervation.
A total of 50 patients with ventricular tachycardia treated with ICD shocks or ATP will be enrolled in this study. The randomization in the study is done before ablation.
For the ablation, an arterial access is required in both groups. During a 30 minutes waiting time which will apply to both groups, renal denervation will be performed.
In this period of time operators and staff will be blinded for the procedure, thereby they won't know if the patients will receive a renal denervation, in that way the investigators are avoiding a bias of future treatment of the patients.
Follow up and repeat procedures:
All Patients will be followed for a period of 3, 6, 9, 12 and 18 months after the procedure.
Regular visits are done in the investigators office. The visit will include ICD Interrogation, VT documentation in ICD Holter, 24-hour Holter ECG or Tele-ECGs, echocardiography.
Re- VT ablations are allowed at any time. In case of renal artery stenosis, denervation will not be performed. Drug therapy can be continued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: Ablation of ventricular arrhythmiasAblation of ventricular arrhythmias |
| intervention group | Sham comparator | Procedure: Ablation of ventricular arrhythmias + renal denervationAblation of ventricular arrhythmias + renal denervation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Ischemic cardiomyopathy
- NYHA II-III
- Recurrent ventricular tachycardia, ICD interventions (shock or ATP)
- Obtained written informed consent
Key exclusion criteria (11 listed)
- Age <18 years
- Previous VT ablation
- NYHA IV
- Cardiopulmonary decompensation within the last 4 weeks
- Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
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 |
|---|---|---|
| Ablation of ventricular arrhythmiascontrol group: Ablation of ventricular arrhythmias | Procedure or surgery | control group |
| Ablation of ventricular arrhythmias + renal denervationIntervention group: Ablation of ventricular arrhythmias + renal denervation | Procedure or surgery | intervention group |
Primary outcome
Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up
Time frame: 24 months
Number of Patients with adverse events such as recurrens of Ventricular
2 secondary outcomes
Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up
Time frame: 24 months
Number of periprocedural complications
Time frame: 24 months
Results and safety
The study was stopped early (reason given: The Sponsor appreciate the devastating impact that the results of the SYMPLICITY HTN 3 trial had on research progress for renal denervation. Based on the lack of recent progress, it is no longer practical to maintain the agreement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No. We at Medtronic certainly appreciate the devastating impact that the results of the SYMPLICITY HTN 3 trial had on research progress for renal denervation, including your trial. Therefore, based on the lack of recent progress, it is no longer practical to maintain our agreement and we are hereby terminating our support for the trial.
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Assessment of Combined CCM and ICD Device in HFrEF
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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.
Stephan Willems, MD principal investigator
ASKLEPIOS St. Georg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation of ventricular arrhythmias and Ablation of ventricular arrhythmias + renal denervation in people with Ventricular Tachycardia and Cardiomyopathy, run by Universitätsklinikum Hamburg-Eppendorf 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 11 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: stopped early, as of the sponsor's last update on 21 Sep 2022. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The Sponsor appreciate the devastating impact that the results of the SYMPLICITY HTN 3 trial had on research progress for renal denervation. Based on the lack of recent progress, it is no longer practical to maintain the agreement.). 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?
Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up (time frame: 24 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 21 Sep 2022.