Tachycardia-induced CardiomyopathyNCT03388905
Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy
A study testing Life Vest Wearable defibrilator in people with Tachycardia-induced Cardiomyopathy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this current study is to prospectively enroll consecutive patients hospitalized with newly diagnosed severe left ventricular dysfunction (LVEF ≤ 35%) for which the likely etiology is uncontrolled atrial fibrillation or high burden of ventricular ectopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia-induced Cardiomyopathy
- What is being tested?
- Life Vest Wearable defibrilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jan 2018to 31 Dec 2019
- 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
- Patients with newly diagnosed left ventricular dysfunction (LVEF ≤ 35% following cardioversion or rate stabilization) with either of the following:
- Newly diagnosed atrial fibrillation
- High burden of premature ventricular contractions (PVCs) (15% of total beats on 24-hour ambulatory Holter recording with a rapid ventricular response > 100 beats per minute prior to initiation of medical therapy) and no other likely heart failure (HF) etiology
- Appropriate management during hospitalization with cardioversion and rhythm control (preferable) or rate control (if cardioversion is contraindicated due to a left atrial thrombus or is not successful)
Who cannot join
- HF likely due to an etiology other than tachyarrhythmia (ischemic etiology, myocarditis, hypertrophic or dilated cardiomyopathy, etc.)
- Unstable clinical condition, life threatening arrhythmia or an established indication for ICD/CRT-D implantation during the index hospitalization
- Patients with ICD/CRT-D or established (> 3 months) heart failure
- Cognitive impairment or unable to utilize WCD appropriately
- Patient has a chest circumference at the level of the xiphoid process either less than 26 inches or greater than 56 inches
Trial locations and contacts
1 site in 1 country.
Nava Levine contact
About this study
Official title: Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy. A Prospective Study
The purpose of this current study is to prospectively enroll consecutive patients hospitalized with newly diagnosed severe left ventricular dysfunction (LVEF ≤ 35%) for which the likely etiology is uncontrolled atrial fibrillation or high burden of ventricular ectopy. Patients completing their established in-hospital treatment plan with rate or rhythm control, will be discharged with a WCD following informed consent and detailed counseling by healthcare personnel for a time-period of up to 3 months until reassessment of LVEF and the need for ICD implantation.
Read the detailed description
TachycardiaInduced Cardiomyopathy (TICMP) refers to impairment in left ventricular function secondary to chronic tachycardia, which is partially or completely reversible once the tachyarrhythmia is controlled. Tachycardia-induced cardiomyopathy has been shown to occur both in experimental models and in patients with incessant tachyarrhythmia (mostly commonly uncontrolled atrial fibrillation). Control of ventricular rate or rhythm by means of cardio-version, negative chronotropic agents, anti-arrhythmic medication and surgical or catheter-based ablation, resulted in significant improvement of systolic function. However, until a possible improvement in left ventricular ejection fraction (LVEF), patients with TICMP with severely depressed systolic function may remain at a high-risk for life-threatening ventricular arrhythmias and sudden cardiac death. While implantable cardioverter defibrillators (ICD) are indicated in patients who fail to improve their left ventricular ejection fraction (LVEF), currently there is no protection from sudden cardiac death (SCD) in patients with TICMP during the high-risk time period from hospital discharge until reassessment of cardiac function and the need for ICD implantation. In this population, the Life Vest wearable cardioverter defibrillator (WCD) may be an appropriate treatment option, providing protection from SCD through timely termination of life-threatening ventricular arrhythmias until stabilization of LVEF. In addition, the monitoring capabilities of the WCD may facilitate remote assessment heart rate control with appropriate titration of medical therapy and evaluation of recurrence of tachyarrhythmias following discharge from hospitalization. Accordingly, the proposed study is the first to prospectively evaluate the benefit of the WCD as an early management strategy in patients with TICMP.
There is no available clinical research data to date on the study device used in TICMP.
This proposed trial is a multicenter single armed prospective study. Thirty patients with newly diagnosed severe LV dysfunction due to uncontrolled tachyarrhythmia will be enrolled following their completion of established in-hospital treatment plan with rate or rhythm control.
Enrolled patients will be discharged with a WCD for a time-period of 3 months. All patients will provide signed informed consent, and detailed counseling by healthcare personnel for a time-period of up to 3 months until reassessment of LVEF and the need for ICD implantation.
The enrollment duration is expected to last 12 months and follow up of additional 12 months from patient inclusion will be performed. An estimation recruitment rate of 1-2 patients per month per center is reasonable based on our preliminary data (see section 6.1). Therefore, it is likely to end up patient's recruitment 10 months following the enrollment phase initiation.
During follow up, patients will be contacted at (1) end of WCD use (2) 3 month and (3) 12 months post enrollment.
Total expected duration of study termination is 24 months from the time first patient was enrolled.
- Conditions
- Tachycardia-induced Cardiomyopathy
- Being tested
- Life Vest Wearable defibrilator
- Keywords
- LifeVest wearable, cardioverter defibrillator, LVEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Vest Wearable defibrilatorDevice
The LifeVest is a cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA). It monitors the patient's heart continuously and, if the patient goes into a life-threatening arrhythmia, can deliver a shock treatment to restore the patient's heart to normal rhythm.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Cardioverter Defibrillator group | Experimental | Not described Receives: Device: Life Vest Wearable defibrilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular recovery following WCD use.
Left ventricular recovery following WCD use.
Measured: 3 months
Secondary outcomes (4)
Recurrence of atrial tachyarrhythmias
Recurrence of atrial tachyarrhythmias
Measured: 12 months
Recurrence of ventricular tachyarrhythmias
Recurrence of ventricular tachyarrhythmias
Measured: 12 months
Appropriate shocks by WCD
Occurrence of appropriate shocks as recorded by WCD (number of Shocks delivered during the follow up period)
Measured: 3 months
Inappropriate shocks by WCD
Occurrence of Inappropriate shocks as recorded by WCD (number of Inappropriate Shocks delivered during the follow up period)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start15 Jan 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia-induced CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ilan Goldenberg, MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388905
- Sponsor's protocol ID
- TICMP
- Status last verified
- Dec 2017
- First submitted
- 3 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy. A Prospective Study
- ClinicalTrials.gov ID
- NCT03388905
- Acronym / sponsor ID
- TICMP
- Conditions
- Tachycardia-induced Cardiomyopathy
- Keywords
- LifeVest wearable, cardioverter defibrillator, LVEF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 3 Jan 2018 (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 purpose of this current study is to prospectively enroll consecutive patients hospitalized with newly diagnosed severe left ventricular dysfunction (LVEF ≤ 35%) for which the likely etiology is uncontrolled atrial fibrillation or high burden of ventricular ectopy. Patients completing their established in-hospital treatment plan with rate or rhythm control, will be discharged with a WCD following informed consent and detailed counseling by healthcare personnel for a time-period of up to 3 months until reassessment of LVEF and the need for ICD implantation.
Detailed description
TachycardiaInduced Cardiomyopathy (TICMP) refers to impairment in left ventricular function secondary to chronic tachycardia, which is partially or completely reversible once the tachyarrhythmia is controlled. Tachycardia-induced cardiomyopathy has been shown to occur both in experimental models and in patients with incessant tachyarrhythmia (mostly commonly uncontrolled atrial fibrillation). Control of ventricular rate or rhythm by means of cardio-version, negative chronotropic agents, anti-arrhythmic medication and surgical or catheter-based ablation, resulted in significant improvement of systolic function. However, until a possible improvement in left ventricular ejection fraction (LVEF), patients with TICMP with severely depressed systolic function may remain at a high-risk for life-threatening ventricular arrhythmias and sudden cardiac death. While implantable cardioverter defibrillators (ICD) are indicated in patients who fail to improve their left ventricular ejection fraction (LVEF), currently there is no protection from sudden cardiac death (SCD) in patients with TICMP during the high-risk time period from hospital discharge until reassessment of cardiac function and the need for ICD implantation. In this population, the Life Vest wearable cardioverter defibrillator (WCD) may be an appropriate treatment option, providing protection from SCD through timely termination of life-threatening ventricular arrhythmias until stabilization of LVEF. In addition, the monitoring capabilities of the WCD may facilitate remote assessment heart rate control with appropriate titration of medical therapy and evaluation of recurrence of tachyarrhythmias following discharge from hospitalization. Accordingly, the proposed study is the first to prospectively evaluate the benefit of the WCD as an early management strategy in patients with TICMP.
There is no available clinical research data to date on the study device used in TICMP.
This proposed trial is a multicenter single armed prospective study. Thirty patients with newly diagnosed severe LV dysfunction due to uncontrolled tachyarrhythmia will be enrolled following their completion of established in-hospital treatment plan with rate or rhythm control.
Enrolled patients will be discharged with a WCD for a time-period of 3 months. All patients will provide signed informed consent, and detailed counseling by healthcare personnel for a time-period of up to 3 months until reassessment of LVEF and the need for ICD implantation.
The enrollment duration is expected to last 12 months and follow up of additional 12 months from patient inclusion will be performed. An estimation recruitment rate of 1-2 patients per month per center is reasonable based on our preliminary data (see section 6.1). Therefore, it is likely to end up patient's recruitment 10 months following the enrollment phase initiation.
During follow up, patients will be contacted at (1) end of WCD use (2) 3 month and (3) 12 months post enrollment.
Total expected duration of study termination is 24 months from the time first patient was enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Cardioverter Defibrillator group | Experimental | Device: Life Vest Wearable defibrilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed left ventricular dysfunction (LVEF ≤ 35% following cardioversion or rate stabilization) with either of the following:
- Appropriate management during hospitalization with cardioversion and rhythm control (preferable) or rate control (if cardioversion is contraindicated due to a left atrial thrombus or is not successful)
Key exclusion criteria (5 listed)
- HF likely due to an etiology other than tachyarrhythmia (ischemic etiology, myocarditis, hypertrophic or dilated cardiomyopathy, etc.)
- Unstable clinical condition, life threatening arrhythmia or an established indication for ICD/CRT-D implantation during the index hospitalization
- Patients with ICD/CRT-D or established (> 3 months) heart failure
- Cognitive impairment or unable to utilize WCD appropriately
- Patient has a chest circumference at the level of the xiphoid process either less than 26 inches or greater than 56 inches
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 |
|---|---|---|
| Life Vest Wearable defibrilatorThe LifeVest is a cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA). It monitors the patient's heart continuously and, if the patient goes into a life-threatening arrhythmia, can deliver a shock treatment to restore the patient's heart to normal rhythm. | Device | Wearable Cardioverter Defibrillator group |
Primary outcome
Left ventricular recovery following WCD use.
Time frame: 3 months
Left ventricular recovery following WCD use.
4 secondary outcomes
Recurrence of atrial tachyarrhythmias
Time frame: 12 months
Recurrence of ventricular tachyarrhythmias
Time frame: 12 months
Appropriate shocks by WCD
Time frame: 3 months
Inappropriate shocks by WCD
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Tachycardia-induced Cardiomyopathy
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Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation
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RecruitingPhase 2/3
Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy
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Enrolling by invitationObservational study
Derivation of Human Induced Pluripotent Stem (iPS) Cells to Heritable Cardiac Arrhythmias
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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.
Nava Levine contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Vest Wearable defibrilator in people with Tachycardia-induced Cardiomyopathy, run by Sheba Medical Center at 1 site in Israel.
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 4 inclusion and 5 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 3 Jan 2018. 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 Israel. 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 Ilan Goldenberg, Prof (972-3-532848, Ilan.Goldenberg@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular recovery following WCD use. (time frame: 3 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 3 Jan 2018.