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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

RESYNC-PETCT Study - 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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07640022
Acronym
RESYNC-PETCT
Enrollment
20
Registered
2026-06-10
Start date
2026-06-15
Completion date
2027-12-15
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac resynchronisation therapy

Brief 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.

Interventions

DEVICECRT-P/CRT-D implantation

CRT-P/CRT-D implantation

Sponsors

Domenichini Giulia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Feasibility of guided coronary sinus lead placement/Improvement in LVEF ≥ 5% measured by TTE and reduction in NYHA ≥ 1CRT implant day and 3/6 months follow-up

Secondary

MeasureTime frame
Improvement in mechanical dyssynchrony assessed by phase analysis of 82Rubidium PET-CT scan/Differences in LVEF, mechanical dyssynchrony, and NYHA class among the study patients implanted with a BIV-CRT approach and the study patients stimulated in LBBAP6 months

Contacts

CONTACTGiulia Domenichini, MD PhD
giulia.domenichini@chuv.ch+41 21 314 11 11
CONTACTChristel C Kamani

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026