Optimization of Coronary Sinus Lead Placement for CRT Delivery in Non-LBBB or Narrow LBBB Pattern… (NCT07640022) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Optimization of Coronary Sinus Lead Placement for CRT Delivery in Non-LBBB or Narrow LBBB Patterns Using Multiparametric 82Rubidium PET-CT Scan Analysis and Cardiac CT Venography
20 participantsStarted 2026-06-15
Plain-language summary
CRT improves outcomes in heart failure patients, but class II candidates (i.e. patients presenting non-LBBB or narrow LBBB patterns) benefit less from this treatment. The RESYNC-PETCT study explores advanced imaging guidance using 82Rubidium PET-CT and cardiac CTV to target coronary sinus lead placement with the aim to improve CRT response in this specific patient population. All genders will be included in this study. However, gender is not considered a variable in this clinical trial.
Patients participating in this study will benefit from an individualized approach to CRT implantation. The nuclear and radiological tests proposed in this research project will imply an additional radiation exposure compared to the standard care. However, the total additional radiation dose will remain below the recommended threshold for clinical trials so that the radiological risks associated to these investigations appear negligible and are counterbalanced by the improvement in LVEF and NYHA expected from a targeted coronary sinus lead positioning.
The objective of the RESYNC-PETCT study is to demonstrate that optimising the coronary sinus lead implantation by using combined data from 82Rubidium PET-CT scan and cardiac CTV reconstruction is a feasible approach to improve the LV electrical and mechanical synchronicity and therefore the clinical response in patients presenting non-LBBB patterns or LBBB patterns with QRS duration \< 150ms.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic heart failure (NYHA class II, III and IV) despite optimal medical treatment
* LVEF ≤ 35%
* Sinus rhythm
* Non LBBB pattern on 12-lead ECG with QRS \> 130 ms
* LBBB pattern on 12-lead ECG with QRS \> 130 ms and \< 150 ms
* Patient is able to understand the nature of the research project and to provide written informed consent.
* Patient accepts to be informed about incidental findings discovered by 82Rubidium PET-CT scan and cardiac CTV that imply clinical management
Exclusion Criteria:
* Pregnancy (as per standard procedure)
* Age less than 18 years
* Severe chronic kidney disease (Glomerular filtration rate \< 30mL/min) contraindicating a cardiac CTV
* Life expectancy of less than 12 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people with non-LBBB or narrow LBBB heart failure patterns — can you tell me whether my ECG pattern would even make me a candidate worth discussing with the team running this study?
2The trial uses an 82Rubidium PET-CT scan combined with a cardiac CT venography to guide where they place the coronary sinus lead during CRT — how much additional radiation exposure would those imaging tests involve compared to what I'd get with standard CRT placement?
3Since this trial is listed as 'not yet recruiting,' do you have a sense of when it might open, and is there a standard CRT approach I should consider in the meantime rather than waiting?
4The trial is measuring whether this guided approach is even feasible, and whether patients see at least a 5% improvement in heart pumping function — given that this is still testing feasibility, what is actually known so far about the safety and benefit of this guided lead placement method versus conventional CRT?
5If my heart failure pattern is the kind that doesn't typically respond as well to standard CRT, what are the other treatment options you'd recommend I explore alongside or instead of this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of guided coronary sinus lead placement/Improvement in LVEF ≥ 5% measured by TTE and reduction in NYHA ≥ 1
Timeframe: CRT implant day and 3/6 months follow-up