Non-left Bundle Branch BlockENHANCE CRTNCT01983293
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
A study testing QLV based implant strategy in people with Non-left Bundle Branch Block and Ischemic or Non-ischemic Cardiomyopathy, run by Abbott Medical Devices at 32 sites in United States.
Trial summary
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-left Bundle Branch Block, Ischemic or Non-ischemic Cardiomyopathy
- What is being tested?
- QLV based implant strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 32 sitesUnited States
- Study dates
- Nov 2013to Jan 2018
- Phase
- Interventional
- 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
- Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration ≥ 120ms)
- Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines:
- Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-LBBB pattern with QRS duration ≥ 120 ms, and NYHA) class III/ambulatory class IV on guideline directed medical therapy
- Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing
- Are 18 years or older, or of legal age to give informed consent specific to state and local law
- Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Who cannot join
- Irreversible occlusion of venous access that will prevent placement of the CRT system either through the right or left upper extremity venous system
- Undergoing left ventricular lead placement via a surgical or epicardial approach
- Cardiomyopathy due solely to valvular disease that is not repaired/replaced
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by St. Jude Medical, during the course of this clinical study
- LBBB: QRS width ≥ 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6
- Incomplete right bundle branch block - intraventricular conduction delay with a QRS duration between 110 and 119ms
Show all 11Show fewer
- Persistent or permanent atrial fibrillation
- Pacemaker dependent
- Patients who are being upgraded primarily due to right ventricular pacing
- Women who are pregnant or who plan to become pregnant during the clinical trial
- Life expectancy < 1 year
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Ohio State University
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Sutherland Cardiology Clinic
Germantown, Tennessee, 38138
Glendale Adventist Medical Center
Glendale, California, 91206
Baker-Gilmour Cardiovascular Institute
Jacksonville, Florida, 32216
Cardiovascular Associates, PC
Kingsport, Tennessee, 37660
Central Baptist Hospital
Lexington, Kentucky, 40503
University of Kentucky
Lexington, Kentucky, 40536
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506
USC University Hospital
Los Angeles, California, 90033
Lynchburg General Hospital
Lynchburg, Virginia, 24501
Northshore University Hospital
Manhasset, New York, 11030
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Cardiovascular Associates of Virginia
Midlothian, Virginia, 23224
Mission Hospital
Mission Viejo, California, 92691
McLaren Macomb
Mount Clemens, Michigan, 48043
Oschner Medical Center
New Orleans, Louisiana, 70448
Baylor Regional Center at Plano
Plano, Texas, 75093
Atlanta Heart Associates - Riverdale
Riverdale, Georgia, 30274
University of Rochester Medical Center
Rochester, New York, 14642
United Hospital
Saint Paul, Minnesota, 55102
Northside Hospital
St. Petersburg, Florida, 33709
St. Joseph's Medical Center
Stockton, California, 95204
Stony Brook University Medical Center
Stony Brook, New York, 11790
North Mississippi Medical Center
Tupelo, Mississippi, 38801
About this study
Official title: Cardiac Resynchronization Therapy (CRT) Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
Read the detailed description
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients.
In the QLV arm the physician will:
- Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement.
- Measure QLV for each of the four cathodes of the left ventricular lead in each branch.
- Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode.
In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
- Being tested
- QLV based implant strategy, Standard of care implant strategy
- Keywords
- Non-left bundle branch block, QLV, LV lead pacing location, CRT-D
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLV based implant strategyDevice
Standard of care implant strategyDevice
| Study group | Role | What they receive |
|---|---|---|
| QLV based implant strategy | Experimental | QLV represents the pacing site with the largest amount of dyssynchrony as measured by the left ventricular electrical delay. The QLV based implant strategy finds the left ventricle vein branch and left ventricular lead cathode with the longest QLV measurement and places the lead at this location and programs the device using this lead cathode. Receives: Device: QLV based implant strategy |
| Standard of care implant strategy | Placebo comparator | The placement of LV lead will be carried out according to the physician's standard of care implant approach. Receives: Device: Standard of care implant strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Improved Clinical Composite Score
Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score.
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 posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2018
- Study completionJan 2018
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 Non-left Bundle Branch BlockStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jagmeet Singh, MD, PhD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983293
- Sponsor's protocol ID
- 60037834
- Acronym
- ENHANCE CRT
- Status last verified
- Feb 2019
- First submitted
- 31 Oct 2013
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Singh JP, Berger RD, Doshi RN, Lloyd M, Moore D, Daoud EG; ENHANCE CRT Study Group. Rationale and design for ENHANCE CRT: QLV implant strategy for non-left bundle branch block patients. ESC Heart Fail. 2018 Dec;5(6):1184-1190. doi: 10.1002/ehf2.12340. Epub 2018 Sep 27.
PubMed 30264456
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy (CRT) Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.
- ClinicalTrials.gov ID
- NCT01983293
- Acronym / sponsor ID
- ENHANCE CRT / 60037834
- Keywords
- Non-left bundle branch block, QLV, LV lead pacing location, CRT-D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 2 Jan 2019
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 study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
Detailed description
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients.
In the QLV arm the physician will:
- Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement.
- Measure QLV for each of the four cathodes of the left ventricular lead in each branch.
- Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode.
In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLV based implant strategy | Experimental | Device: QLV based implant strategyQLV represents the pacing site with the largest amount of dyssynchrony as measured by the left ventricular electrical delay. The QLV based implant strategy finds the left ventricle vein branch and left ventricular lead cathode with the longest QLV measurement and places the lead at this location and programs the device using this lead cathode. |
| Standard of care implant strategy | Placebo comparator | Device: Standard of care implant strategyThe placement of LV lead will be carried out according to the physician's standard of care implant approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration ≥ 120ms)
- Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines:
- Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing
- Are 18 years or older, or of legal age to give informed consent specific to state and local law
- Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Key exclusion criteria (11 listed)
- Irreversible occlusion of venous access that will prevent placement of the CRT system either through the right or left upper extremity venous system
- Undergoing left ventricular lead placement via a surgical or epicardial approach
- Cardiomyopathy due solely to valvular disease that is not repaired/replaced
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by St. Jude Medical, during the course of this clinical study
- LBBB: QRS width ≥ 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6
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 |
|---|---|---|
| QLV based implant strategy | Device | QLV based implant strategy |
| Standard of care implant strategy | Device | Standard of care implant strategy |
Primary outcome
Number of Patients With Improved Clinical Composite Score
Time frame: 12 months
Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30264456Singh JP, Berger RD, Doshi RN, Lloyd M, Moore D, Daoud EG; ENHANCE CRT Study Group. Rationale and design for ENHANCE CRT: QLV implant strategy for non-left bundle branch block patients. ESC Heart Fail. 2018 Dec;5(6):1184-1190. doi: 10.1002/ehf2.12340. Epub 2018 Sep 27.
- Individual participant dataSharing planned: No
Related trials for Non-left Bundle Branch Block
Recruiting
Clinical Efficacy and Safety of Left Bundle Branch Area Pacing Using Quantitative Guidance of Multimodal Data in the Treatment of Heart Failure
Heart Failure, Left Bundle Branch Block
Active, not recruitingObservational study
Factors Associated With Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Non-LBBB ECG Pattern
Cardiomyopathies, Heart Failure
Active, not recruiting
LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB
Non-ischemic Cardiomyopathy, Heart Failure
Not yet recruiting
LLL vs. SDL for LBBP: A Non-inferiority RCT
Bradycardia, Conduction Block, Atrioventricular
Recruiting
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
Heart Failure, Left Bundle-Branch Block
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.
Jagmeet Singh, MD, PhD study chair
Massachusetts General Hospital
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QLV based implant strategy in people with Non-left Bundle Branch Block and Ischemic or Non-ischemic Cardiomyopathy, run by Abbott Medical Devices at 32 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 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: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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. 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?
Yes. Results are posted in the registry (first posted 2 Jan 2019). 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?
Number of Patients With Improved Clinical Composite Score (time frame: 12 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 NCT01983293, 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 13 Mar 2019.