An interventional study of HOT-CRT and Biventricular Pacing in Heart Failure，Congestive, Cardiomyopathies and Left Ventricular Dysfunction, sponsored by Pugazhendhi Vijayaraman. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Pugazhendhi Vijayaraman · Not applicable, Interventional, and Treatment
This is a randomized, prospective, single-blinded trial to determine the overall rate of successful His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT) versus biventricular pacing using coronary sinus lead (BVP) to compare acute and mid-term outcomes. Acute outcomes include change in QRS duration pre-and post-pacing (degree of QRS narrowing) and incidence of major periprocedural complications (pericardial tamponade, need for lead revision, etc.). Mid-term outcomes include echocardiographic response at 6 months along with a composite clinical outcome of heart failure hospitalization, ventricular arrhythmias, crossover, and all-cause mortality.
This is a single-blinded study of 100 patients randomized to a strategy of His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT) versus biventricular pacing using coronary sinus (CS) lead (BVP). Both treatment options use standard-of-care, FDA-approved devices. The distinction is only in the allocation toward HOT-CRT and BVP. Treating physicians will be aware of assignment in order to facilitate routine device follow-up. Echocardiographic and electrocardiographic evaluation will also be performed in a blinded manner.
Cross-over is permitted between treatment group allocation if:
CS lead cannot be placed due to difficult cannulation of the CS, limited branches at the posterolateral or lateral wall, or phrenic nerve capture. These subjects may then cross-over to HOT-CRT.
HOT-CRT subjects may cross-over if His or left bundle pacing lead cannot be positioned with adequate stability and reasonable pacing output, or if optimal QRS narrowing cannot be achieved.
Implant procedure will be per routine percutaneous access, as is standard for pacemaker and Implantable Cardioverter Defibrillators (ICDs). . All subjects will receive an FDA-approved cardiac resynchronization therapy pacemaker or defibrillator device, as per standard of care outlined for the subject.
Follow-up will be performed at 2 weeks post-implant for incision check and device interrogation as is standard of care. In addition, routine device and clinical follow-up will be scheduled at 3 and 6 months. Electrocardiography (ECG) will be performed pre-implant, prior to hospital discharge, at 3 months, and 6 months. Echocardiography will be performed pre-implant and 6 months to evaluate for change in Left Ventricular Ejection Fraction (LVEF), chamber dimensions, volumes, and change in Left Ventricular (LV) end systolic volume index as is standard of care in the treatment of patients with advanced heart failure. New York Heart Association (NYHA) functional class and quality of life (utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ 5D) will be assessed pre-implant and at 6 months.
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 100 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Pugazhendhi Vijayaraman is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Diagnosis is NYHA Class II, III, and ambulatory Class IV heart failure with either ischemic or nonischemic cardiomyopathy and patients with NYHA Class I symptoms and ischemic cardiomyopathy, with at least one of the following:
Exclusion Criteria:
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
Device: HOT-CRT
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.
Device: Biventricular Pacing
Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
Primary Endpoint
Improvement in left ventricular ejection fraction (LVEF) - change in LVEF% measured by 2D echo at 6 months compared to baseline
Time frame: 6 months
Primary Safety
Freedom from major complications or need for CRT lead revision - complication such as lead dislodgment, pericardial tamponade, pneumothorax, systemic embolism, phrenic nerve stimulation not correctable by programming
Time frame: 6 months
Secondary Composite
Crossover, ventricular tachycardia (VT)/ventricular fibrillation (VF), Heart failure hospitalization (HFH) or death
Time frame: 6 months
Echocardiographic Response
change in LVEF \>5%
Time frame: 6 months
Subjects will be recruited from Geisinger Wyoming Valley, Geisinger Medical Center, and Geisinger Community Medical Center. Investigators will identify eligible subjects, describe the study procedures and invite them to participate in the study. Informed Consent (ICF) will be provided to the subject and they will have ample time and opportunity to review and consider participation. Prior to performing any study procedures, the subject will sign the ICF and be considered enrolled at that point.
| Milestone | BiV Pacing | HOT-CRT |
|---|---|---|
| Started | 50 | 50 |
| Cross over to hotcrt | 9 | 0 |
| Cross over to biv | 0 | 2 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
Improvement in left ventricular ejection fraction (LVEF) - change in LVEF% measured by 2D echo at 6 months compared to baseline
| percent ejection fraction | HOT-CRT | Biventricular Pacing |
|---|---|---|
| Primary Endpoint | 12.4 ± 7.3 | 8.0 ± 10.1 |
Freedom from major complications or need for CRT lead revision - complication such as lead dislodgment, pericardial tamponade, pneumothorax, systemic embolism, phrenic nerve stimulation not correctable by programming
| Participants | HOT-CRT | Biventricular Pacing |
|---|---|---|
| Primary Safety | 49 | 48 |
Crossover, ventricular tachycardia (VT)/ventricular fibrillation (VF), Heart failure hospitalization (HFH) or death
| Participants | HOT-CRT | Biventricular Pacing |
|---|---|---|
| Secondary Composite | 9 | 14 |
change in LVEF \>5%
| Participants | HOT-CRT | Biventricular Pacing |
|---|---|---|
| Echocardiographic Response | 35 | 27 |
Collected over Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HOT-CRT | 2/57 (3.5%) | 17/57 (29.8%) | 0/57 (0%) |
| Biventricular Pacing | 2/43 (4.7%) | 32/43 (74.4%) | 0/43 (0%) |
| Event | HOT-CRT | Biventricular Pacing |
|---|---|---|
| Secondary composite clinical endpointCardiac disorders | 9/50 | 14/43 |
| TotalCardiac disorders | 3/57 | 10/43 |
| Threshold increase >1 VCardiac disorders | 2/57 | 4/43 |
| Phrenic nerve stimulationCardiac disorders | 0/57 | 4/43 |
| Lead dislodgementCardiac disorders | 3/57 | 2/43 |
| InfectionInfections and infestations | 0/57 | 1/43 |
| Hematoma requiring evacuationSurgical and medical procedures | 0/57 | 1/43 |
| StrokeCardiac disorders | 0/57 | 0/43 |
| Late perforation into left ventricleCardiac disorders | 0/57 | 0/43 |
| Cardiac tamponadeCardiac disorders | 0/57 | 0/43 |
50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
| Age, Continuous(years) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| All patients | 71 ± 13.4 | 68.9 ± 11.5 | 70 ± 12.5 |
| Sex: Female, Male(Participants) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| All patients — Female | 11 | 20 | 31 |
| All patients — Male | 39 | 30 | 69 |
| Race and Ethnicity Not Collected(Participants) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Hypertension(Participants) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| Count of participants | 42 | 38 | 80 |
| Diabetes(Participants) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| Count of participants | 26 | 23 | 49 |
| Coronary Artery Disease(Participants) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| Count of participants | 23 | 22 | 45 |
| Atrial fibrillation(Participants) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| Count of participants | 12 | 22 | 34 |
| Chronic kidney disease(Participants) | HOT-CRT | Biventricular Pacing | Total |
|---|---|---|---|
| Count of participants | 17 | 18 | 35 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Apr 2021 to primary completion in May 2023, 24 months.
Results were first posted in Aug 2024, 1 year 2 months after primary completion.
Of 1,018 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 24 months is below that.
Counting every sponsor, half of 1,220 studies reached it within 31 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Pugazhendhi Vijayaraman