Heart FailureNCT03305393
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
A study testing Adaptiv CRT in people with Heart Failure, run by Stern Cardiovascular Foundation, Inc. at 1 site in United States.
Trial summary
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Adaptiv CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2017to 3 Jul 2018
- 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
- Normal AV conduction (SAV<220 ms or PAV<270 MS)
- Left Bundle Branch Block (defined as > or = to 140 ms (male) or > or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
- Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
- Sinus Rhythm at the time of enrollment
Who cannot join
- Moderate to severe Aortic Stenosis
- Moderate to severe Mitral Regurgitation
- Patient age <18 years old
- AF burden >15%
- Severe pulmonary disease requiring supplemental oxygen use
- ESRD
Show all 11Show fewer
- System Modification at RRT Generator Changeout
- AdaptivCRT prior to enrollment
- Expected patient longevity < 1 year
- Persistant or chronic atrial fibriliation
- Women who are pregnant or who plan to become pregnant during the clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
About this study
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.
- Conditions
- Heart Failure
- Being tested
- Adaptiv CRT
- Keywords
- Heart Failure, CRT, Cardiac Recynchronization Therapy, left bundle branch block, atrio-ventricular conduction
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptiv CRTDevice
Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| Adaptiv CRT | Other | Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit Receives: Device: Adaptiv CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection fraction
Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
Measured: 12 Months
NYHA functional class
Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
Measured: 12 months
Secondary outcomes (5)
Atrial fibrillation burden
Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review
Measured: 12 Months
Heart failure hospitalizations
Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects
Measured: 12 months
Left ventricular end systolic volume
As determined by echocardiographic evidence
Measured: 12 months
Time to first appropriate therapy for VT and/or VF
Time determined by device interrogation from sensing to response
Measured: 12 months
Percentage of RV synchronized LV pacing
Percentage determined by device interrogation and compared to clinical outcomes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start11 Jun 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Why it stopped: Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stern Cardiovascular Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305393
- Sponsor's protocol ID
- IMPROVE RESPONSE
- Status last verified
- Sep 2019
- First submitted
- 15 Aug 2017
- Last updated
- 19 Sep 2019
- 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 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
- ClinicalTrials.gov ID
- NCT03305393
- Acronym / sponsor ID
- IMPROVE RESPONSE
- Conditions
- Heart Failure
- Keywords
- Heart Failure, CRT, Cardiac Recynchronization Therapy, left bundle branch block, atrio-ventricular conduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stern Cardiovascular Foundation, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 10 Oct 2017 (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.
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptiv CRT | Other | Device: Adaptiv CRTAdaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normal AV conduction (SAV<220 ms or PAV<270 MS)
- Left Bundle Branch Block (defined as > or = to 140 ms (male) or > or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
- Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
- Sinus Rhythm at the time of enrollment
Key exclusion criteria (11 listed)
- Moderate to severe Aortic Stenosis
- Moderate to severe Mitral Regurgitation
- Patient age <18 years old
- AF burden >15%
- Severe pulmonary disease requiring supplemental oxygen use
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 |
|---|---|---|
| Adaptiv CRTAdaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit | Device | Adaptiv CRT |
Primary outcome
Ejection fraction
Time frame: 12 Months
Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
NYHA functional class
Time frame: 12 months
Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
5 secondary outcomes
Atrial fibrillation burden
Time frame: 12 Months
Heart failure hospitalizations
Time frame: 12 months
Left ventricular end systolic volume
Time frame: 12 months
Time to first appropriate therapy for VT and/or VF
Time frame: 12 months
Percentage of RV synchronized LV pacing
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Adaptiv CRT in people with Heart Failure, run by Stern Cardiovascular Foundation, Inc. at 1 site 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 4 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 19 Sep 2019. 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 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.
Are results available for this study?
The study was stopped early (reason given: Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.). 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?
Ejection fraction (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 19 Sep 2019.