An interventional study of LOT-CRT-P (Programming: LBBAP) and LOT-CRT-P (Programming: LOT-CRT-P) in Heart Failure, Left Bundle Branch Area Pacing and Cardiac Resynchronization Therapy, sponsored by PD Dr. Guram Imnadze. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by PD Dr. Guram Imnadze · Not applicable, Interventional, and Treatment
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Among 600 studies in Heart Failure with a site in Germany — 107 open to participants now, 137 under way, 19 of them phase 3. Heart Failure · Germany.
Among the 600 studies in Heart Failure with a site in Germany, this one is the 218th largest by planned enrollment of the 386 interventional ones that give a count, is the only one that started in 2027, is one of 175 with no phase, reaches primary completion later than 107 of the 136 other live ones, and was the 599th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →107 of the 600 studies in Heart Failure with a site in Germany are open now. Recruiting first, the newest first:
Leipzig Heart Science gGmbH · Sites in Germany
Ages 18–80
Edwards Lifesciences · Sites in Germany
Ages 18+
Stephan Baldus · Sites in Germany
Ages 18+
Jena University Hospital · Sites in Germany
Ages 18+
AstraZeneca · Sites in Germany, United States, Argentina and 29 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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600 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 82 · Phase 3 91 · Phase 4 32
First in 1983; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 124 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 161 across the 386 interventional studies, 286 across the 212 observational. Of the 411 that completed or were terminated, 126 (31%) have results posted.
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356 of 600 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with PD Dr. Guram Imnadze as lead sponsor.
PD Dr. Guram Imnadze has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
35 of the studies in Heart Failure with a site in Germany that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT07038356Phase 3Christian SchulzeEffects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure | 2027-04-30 |
| NCT05374291Phase 3University Medical Center GroningenThe RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD | 2027-07 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Add all 35 to your calendar (.ics) → With an account.
Among the 600 studies in Heart Failure with a site in Germany, from their registry updates:
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Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy and may offer advantages over conventional biventricular pacing (BVP), including improved clinical outcomes. However, its effectiveness may be limited in patients with distal conduction system disease, significant endocardial and/or myocardial damage, as well as when direct left bundle branch capture is not achieved. Conventional CRT remains an effective therapy but is associated with procedural challenges and a significant non-responder rate. Current guidelines support the use of LBBAP and BVP either individually or in combination as Left Bundle Branch Optimized CRT (LOT-CRT). Recent data suggest that LOT-CRT may provide superior electrical and hemodynamic resynchronization compared with both LBBAP and BVP. However, there is a lack of randomized trials comparing LBBAP and LOT-CRT in patients with CRT-P indication. The aim of this study is to compare the LOT-CRTP to LBBAP alone.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18 years Clinical indication for CRTP implantation according to the current ESC guidelines De novo implantation LBBB (QRS duration ≥130 ms) II-IV
Exclusion Criteria:
Severe mitral or aortic valvular disease History of VT/VF Failed implantation of any component of the LOT-CRTP system/ incompleteness of the system to be implanted Pregnancy \< 1 year Inability to give written consent
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LOT group: Implanted with LOT-CRT-P device and programmed with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG.
Device: LOT-CRT-P (Programming: LOT-CRT-P)
NOT group: Implanted with LOT-CRT-P device and programmed with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms.
Device: LOT-CRT-P (Programming: LBBAP)
All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: NOT group: Synchronized with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment.
Device: LOT-CRT-P (Programming: LOT-CRT-P) All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: LOT group: Pacing with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment.
Clinical Status
Hierarchical clinical composite score: 1. Patients who died for a cardiovascular cause, received a heart transplantation or had an unplanned emergency department visit or hospitalization for heart failure are 'unchanged/worsened'. 2\. Patients who receive a modification of the implanted CRTP system for reasons of presumed inefficacy of the randomized system are 'unchanged/worsened'. 3\. Patients to whom the above does not apply and who have \>20% absolute increase in LVEF at 12 months or earlier are 'markedly improved', and patients who have \<5% absolute increase in LVEF at 12 months are 'unchanged/worsened' 4. Patients to whom the above does not apply the KCCQ-12 overall summary score will be assessed. Those who have ≥ 5 points increase in KCCQ-12 overall summary score are 'markedly improved', and patients who have ≥5 points decrease are 'unchanged/worsened'. 5\. Patients for whom none of the conditions above apply, are 'moderately improved'.
Time frame: From enrollment to 12 month follow up
Electrocardiographic characteristics
ECG: QRS duration, assessment of LV lateral wall activation time and LV lateral wall to RV septal activation time.
Time frame: enrollment to 12 month follow up
Echocardiographic characteristics
left ventricular ejection fraction (LVEF), left ventricular end-systolic/ end-diastolic volume (LVESV/LVEDV), LV EDD, LV ESD.
Time frame: enrollment to 12 month follow up
NYHA class
Time frame: enrollment to 12 month follow up
NT-ProBNP
Time frame: enrollment to 12 month follow up
6 minutes walking test
Time frame: enrollment to 12 month follow up
Quality of Life Questionaire
KCCQ-12
Time frame: enrollment to 12 month follow up
Worsened heart failure
Time frame: enrollment to 12 month follow up
Arrhythmic events
VT/VF/AF occurrence
Time frame: enrollment to 12 month follow up
Mortality
Time frame: enrollment to 12 month follow up
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Mar 2029, 25 months later.
Of 1,118 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 planned 25 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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