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)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: CRT-P/CRT-D implantation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulia Domenichini, MD PhD; Phone Number: +41 21 314 11 11; Email: giulia.domenichini@chuv.ch
• Study Contact Backup: Name: Christel C Kamani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart failure patients with CRT indications	Device: CRT-P/CRT-D implantation; CRT-P/CRT-D implantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time 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 LBBAP	6 months

Collaborators and Investigators

• Sponsor: Domenichini Giulia

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac resynchronisation therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2025-01979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No