Sudden Cardiac DeathPhase 4NCT00626093
'Effect of CRT on Defibrillation Threshold Estimates' Study
A Phase 4 study testing Cardiac Resynchronization Therapy - Defibrillator (CRT-D) in people with Sudden Cardiac Death, run by Abbott Medical Devices at 2 sites in United States.
Trial summary
The purpose of this prospective study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization therapy defibrillators (CRT-D) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Apr 2010
- Phase
- Phase 4
- 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
Who may be able to join
- Patient meets standard indications for a Cardiac Resynchronization Therapy - Defibrillator (CRT-D).
- Patient will be implanted with an FDA approved St Jude Medical (SJM) Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and compatible defibrillation lead system.
- Patient is able to tolerate defibrillation threshold (DFT) testing.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Patient has a life expectancy of greater than 6 months from the time of implant.
- Patient has stable heart failure (HF) medications at least one month prior to enrollment.
Who cannot join
- Inability to successfully implant an intravascular lead Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device. (i.e. exclude epicardial leads).
- Patient is getting his Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device replaced.
- Inability to successfully obtain the defibrillation threshold (DFT) at implant.
- Currently participating in a clinical trial that includes an active treatment arm or another data collection registry.
- Recent (within 24 hours) administration of Nesiritide™.
- Patient is on amiodarone (other antiarrhythmic agents known to affect defibrillation thresholds - DFTs) at the time of enrollment.
- Patient is pregnant.
- Patient is less than 18 years old.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penrose Hospital
Colorado Springs, Colorado, 80907
Pacific Heart Institute
Santa Monica, California, 90404
About this study
Official title: Effect of Cardiac Resynchronization Therapy (CRT) on the Defibrillation Threshold (DFT) Estimates
The purpose of this prospective study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization therapy defibrillators (CRT-D) patients. The hypothesis of the study is that defibrillation threshold (DFT) will decrease with 6 months of cardiac resynchronization therapy (CRT).
Read the detailed description
Cardiac Resynchronization Therapy (CRT) has emerged as a promising therapeutic addition in patients with drug refractory heart failure (HF). Along with providing relief of symptoms of HF, cardiac resynchronization therapy defibrillators (CRT-D) are used for the prevention of sudden cardiac death (SCD). Although there are concerns that the defibrillation threshold (DFT) estimates are elevated in the heart failure (HF) patient population due to lower LV ejection fraction (EF) and left ventricular (LV) dysfunction, there is paucity of data available to evaluate this theory.
Recently, two different studies in a retrospective manner evaluated the energy requirements in patients receiving cardiac resynchronization therapy defibrillators (CRT-D). Burke et al analyzed DFTs in 50 patients each implanted with a cardiac resynchronization therapy defibrillators (CRT-D) device and an implantable cardioverter defibrillator (ICD). Although the ejection fraction (EF) in cardiac resynchronization therapy defibrillators (CRT- D) group was lower than the implantable cardioverter defibrillator (ICD) group, the mean defibrillation thresholds (DFTs) between the two groups were not significantly different (10.2 ± 6.1 J for the cardiac resynchronization therapy (CRT) group vs. 9.5 ± 5.0 J for the control group)14. In the ASSURE study, Doshi et al. showed that patients receiving cardiac resynchronization therapy defibrillators (CRT-D) devices do not have higher energy requirements when compared to patients receiving modern single or dual chamber implantable cardioverter defibrillators (ICDs). Although, there was a trend toward higher energy requirements found among patients with higher degrees of heart failure.
Major cardiac resynchronization therapy (CRT) trials have showed that cardiac resynchronization therapy (CRT) therapy has positive effects on ejection fraction (EF) and the heart failure (HF) condition of the patient over time. But, there is no study that has evaluated the defibrillation thresholds (DFTs) in the heart failure (HF) patients over time of receiving cardiac resynchronization therapy (CRT). This information will help the clinicians decide if they need to perform more invasive procedures during device implant to lower DFTs in patients who do not meet the defibrillation safety margin or they should just wait over time for the CRT to reduce the defibrillation threshold (DFT). Also, there is no published data about the stability of defibrillation thresholds (DFTs) in heart failure (HF) patients over time. The results from this study will also help to clarify whether it is safe to never test the defibrillation thresholds (DFTs) post-implant in this patient population.
- Conditions
- Sudden Cardiac Death
- Being tested
- Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy - Defibrillator (CRT-D)Device
Also called Epic HF,Atlas+ HF,Epic II HF,Atlas II HF,Promote CRT-D
- Patients in the study who receive Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for Cardiac Resynchronization Therapy (CRT).
- Patient undergoes Defibrillation threshold (DFT) testing at implant and at 6 months. Defibrillation threshold (DFT) testing will include 3 ventricular fibrillation (VF) inductions.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Resynchronization Therapy - Defibrillator (CRT-D) | Other | Patients in the study who received a Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for it. It's a single arm study in which patients underwent defibrillation threshold (DFT) testing at implant and 6 months. Receives: Device: Cardiac Resynchronization Therapy - Defibrillator (CRT-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months
All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.
Measured: Baseline and 6 months
Secondary outcomes (1)
Defibrillation Threshold Difference Obtained in Joules (J)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionApr 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Hedayati, MD, Principal investigator, Glendale Heart InstituteMichael Gold, MD, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626093
- Sponsor's protocol ID
- CRD 388
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2008
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gold MR, Hedayati A, Alaeddini J, Payne JP, Bailin S, Sturdivant JJ, Pradhan S, Oza AL. Temporal stability of defibrillation thresholds with cardiac resynchronization therapy. Heart Rhythm. 2011 Jul;8(7):1008-13. doi: 10.1016/j.hrthm.2011.02.006. Epub 2011 Feb 9.
PubMed 21315841
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiac Resynchronization Therapy (CRT) on the Defibrillation Threshold (DFT) Estimates
- ClinicalTrials.gov ID
- NCT00626093
- Acronym / sponsor ID
- CRD 388
- Conditions
- Sudden Cardiac Death
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 21 Jan 2013
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 prospective study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization therapy defibrillators (CRT-D) patients. The hypothesis of the study is that defibrillation threshold (DFT) will decrease with 6 months of cardiac resynchronization therapy (CRT).
Detailed description
Cardiac Resynchronization Therapy (CRT) has emerged as a promising therapeutic addition in patients with drug refractory heart failure (HF). Along with providing relief of symptoms of HF, cardiac resynchronization therapy defibrillators (CRT-D) are used for the prevention of sudden cardiac death (SCD). Although there are concerns that the defibrillation threshold (DFT) estimates are elevated in the heart failure (HF) patient population due to lower LV ejection fraction (EF) and left ventricular (LV) dysfunction, there is paucity of data available to evaluate this theory.
Recently, two different studies in a retrospective manner evaluated the energy requirements in patients receiving cardiac resynchronization therapy defibrillators (CRT-D). Burke et al analyzed DFTs in 50 patients each implanted with a cardiac resynchronization therapy defibrillators (CRT-D) device and an implantable cardioverter defibrillator (ICD). Although the ejection fraction (EF) in cardiac resynchronization therapy defibrillators (CRT- D) group was lower than the implantable cardioverter defibrillator (ICD) group, the mean defibrillation thresholds (DFTs) between the two groups were not significantly different (10.2 ± 6.1 J for the cardiac resynchronization therapy (CRT) group vs. 9.5 ± 5.0 J for the control group)14. In the ASSURE study, Doshi et al. showed that patients receiving cardiac resynchronization therapy defibrillators (CRT-D) devices do not have higher energy requirements when compared to patients receiving modern single or dual chamber implantable cardioverter defibrillators (ICDs). Although, there was a trend toward higher energy requirements found among patients with higher degrees of heart failure.
Major cardiac resynchronization therapy (CRT) trials have showed that cardiac resynchronization therapy (CRT) therapy has positive effects on ejection fraction (EF) and the heart failure (HF) condition of the patient over time. But, there is no study that has evaluated the defibrillation thresholds (DFTs) in the heart failure (HF) patients over time of receiving cardiac resynchronization therapy (CRT). This information will help the clinicians decide if they need to perform more invasive procedures during device implant to lower DFTs in patients who do not meet the defibrillation safety margin or they should just wait over time for the CRT to reduce the defibrillation threshold (DFT). Also, there is no published data about the stability of defibrillation thresholds (DFTs) in heart failure (HF) patients over time. The results from this study will also help to clarify whether it is safe to never test the defibrillation thresholds (DFTs) post-implant in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Resynchronization Therapy - Defibrillator (CRT-D) | Other | Device: Cardiac Resynchronization Therapy - Defibrillator (CRT-D)Patients in the study who received a Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for it. It's a single arm study in which patients underwent defibrillation threshold (DFT) testing at implant and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient meets standard indications for a Cardiac Resynchronization Therapy - Defibrillator (CRT-D).
- Patient will be implanted with an FDA approved St Jude Medical (SJM) Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and compatible defibrillation lead system.
- Patient is able to tolerate defibrillation threshold (DFT) testing.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Patient has a life expectancy of greater than 6 months from the time of implant.
Key exclusion criteria (8 listed)
- Inability to successfully implant an intravascular lead Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device. (i.e. exclude epicardial leads).
- Patient is getting his Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device replaced.
- Inability to successfully obtain the defibrillation threshold (DFT) at implant.
- Currently participating in a clinical trial that includes an active treatment arm or another data collection registry.
- Recent (within 24 hours) administration of Nesiritide™.
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 |
|---|---|---|
| Cardiac Resynchronization Therapy - Defibrillator (CRT-D)Also: Epic HF,Atlas+ HF,Epic II HF,Atlas II HF,Promote CRT-D* Patients in the study who receive Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for Cardiac Resynchronization Therapy (CRT). * Patient undergoes Defibrillation threshold (DFT) testing at implant and at 6 months. Defibrillation threshold (DFT) testing will include 3 ventricular fibrillation (VF) inductions. | Device | Cardiac Resynchronization Therapy - Defibrillator (CRT-D) |
Primary outcome
Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months
Time frame: Baseline and 6 months
All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.
1 secondary outcome
Defibrillation Threshold Difference Obtained in Joules (J)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21315841Gold MR, Hedayati A, Alaeddini J, Payne JP, Bailin S, Sturdivant JJ, Pradhan S, Oza AL. Temporal stability of defibrillation thresholds with cardiac resynchronization therapy. Heart Rhythm. 2011 Jul;8(7):1008-13. doi: 10.1016/j.hrthm.2011.02.006. Epub 2011 Feb 9.
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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.
Amir Hedayati, MD principal investigator
Glendale Heart Institute
Michael Gold, MD, PhD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cardiac Resynchronization Therapy - Defibrillator (CRT-D) in people with Sudden Cardiac Death, run by Abbott Medical Devices at 2 sites in United States.
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 6 inclusion and 8 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 5 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2013). 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?
Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months (time frame: Baseline and 6 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 NCT00626093, 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 5 Feb 2019.