HF PatientOpsite 2NCT03204864
Optimization of Coronary Sinus Lead Placement Targeted to the Longest Right-to-Left Delay
A study testing RLD Group and Conventional CS lead placement in people with HF Patient, run by Michele Brignole at 4 sites in Italy.
Trial summary
This study is a prospective, multi-center, physician-initiated study, with intra-center control arm of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) with or without defibrillator therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HF Patient
- What is being tested?
- RLD Group and Conventional CS lead placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Mar 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be in NYHA II or III functional class with approved class I or II standard indications by ESC/EHRA Guidelines
- Either patients in sinus rhythm or in atrial fibrillation. In this latter case patients must perform AV node ablation if complete biventricular stimulation cannot be achieved in >95% of beats
- Patients willing and able to comply with study requirements(patients must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form)
- Successful LV lead implant
Who cannot join
- Myocardial Infarction, unstable angina within 40 days prior the enrollment
- Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
- Primary valvular disease
- Unable to comply with the follow up schedule
- Less than 18 years of age
Show all 10Show fewer
- Pregnant or are planning to become pregnant during the duration of the investigation
- Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
- Undergone a cardiac transplantation
- Life expectancy < 12 months
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Ospedale Villa Scassi
Genova
Ospedale di Imperia
Imperia
Ospedale del Tigullio-Polo di Lavagna
Lavagna
Ospedale di Massa
Massa
About this study
This study is a prospective, multi-center, physician-initiated study, with intra-center control arm of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) with or without defibrillator therapy.
The purpose of this study is to verify whether optimizing the left ventricular lead position at implantation with the pacing cathode corresponding to the longest RV-to-LV electrical delay may result in a better patient outcome. The RV-to-LV electrical delay will be evaluated with RLD value (ms). RLD is the distance between the Right Ventricular pacing marker (VP) and the maximum peak (or the first maximum peak in case of two equally tall peaks) of the LV bipolar deflection.
Read the detailed description
This study is a prospective, multi-center, physician-initiated study, with intra-center control arm of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) with or without defibrillator therapy.
Approximately 300 patients will be included in the study and followed-up for 6 months. Patients recruitment will consist of two sequential phases:
Phase 1 - Conventional CS lead placement (Conventional subgroup). The first 100 patients will be implanted with a CRT device with or without defibrillator (P/D) as per standard clinical practice, without CS lead pacing specific optimization. In these patients RLD is measured blind to implanting physician who will place CS lead according to his/her clinical practice. Since these patients follow strictly standard clinical practice, their implantation data can be collected prospectively or even retrospectively when available.
Phase 2 - Targeted CS lead placement (RLD subgroup). In the second 200 patients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold.
- Conditions
- HF Patient
- Being tested
- RLD Group, Conventional CS lead placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLD GroupDevice
Also called CRT
patients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold.
Conventional CS lead placementDevice
Also called CRT
Clinical Practice
| Study group | Role | What they receive |
|---|---|---|
| Conventional CS lead placement | Active comparator | Patients will be implanted with a CRT device with or without defibrillator (P/D) as per standard clinical practice, without CS lead pacing specific optimization. Receives: Device: Conventional CS lead placement |
| RLD Group | Experimental | Patients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold. Receives: Device: RLD Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Composite Score -3 months
Improvement in clinical composite score
Measured: 3 months
Secondary outcomes (1)
Clinical Composite Score-6 months
Clinical composite score evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Mar 2016
- Primary completion30 Sep 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HF PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1. Conventional CS lead placement Phase 2. CS placement guided by RLD measurement
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele Brignole
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michele Brignole, Ospedale del Tigullio, Polo di Lavagna
- Investigators
- Michele Brignole, MD, Principal investigator, Ospedale del Tigullio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204864
- Sponsor's protocol ID
- Ver 5.0
- Acronym
- Opsite 2
- Status last verified
- Sep 2018
- First submitted
- 27 Jun 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oddone D, Solari D, Arena G, Mureddu R, Nangah R, Giorgi D, Senatore G, Bottoni N, Giaccardi M, Laffi M, Giammaria M, Sitta N, Marras E, Cipolla E, Di Lorenzo F, Carpi R, Brignole M. Optimization of coronary sinus lead placement targeted to right-to-left delay in patients undergoing cardiac resynchronization therapy. Europace. 2019 Mar 1;21(3):502-510. doi: 10.1093/europace/euy275.
PubMed 30508076
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Coronary Sinus Lead Placement Targeted to the Longest Right-to-Left Delay
- ClinicalTrials.gov ID
- NCT03204864
- Acronym / sponsor ID
- Opsite 2 / Ver 5.0
- Conditions
- HF Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Michele BrignoleUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multi-center, physician-initiated study, with intra-center control arm of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) with or without defibrillator therapy.
The purpose of this study is to verify whether optimizing the left ventricular lead position at implantation with the pacing cathode corresponding to the longest RV-to-LV electrical delay may result in a better patient outcome. The RV-to-LV electrical delay will be evaluated with RLD value (ms). RLD is the distance between the Right Ventricular pacing marker (VP) and the maximum peak (or the first maximum peak in case of two equally tall peaks) of the LV bipolar deflection.
Detailed description
This study is a prospective, multi-center, physician-initiated study, with intra-center control arm of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) with or without defibrillator therapy.
Approximately 300 patients will be included in the study and followed-up for 6 months. Patients recruitment will consist of two sequential phases:
Phase 1 - Conventional CS lead placement (Conventional subgroup). The first 100 patients will be implanted with a CRT device with or without defibrillator (P/D) as per standard clinical practice, without CS lead pacing specific optimization. In these patients RLD is measured blind to implanting physician who will place CS lead according to his/her clinical practice. Since these patients follow strictly standard clinical practice, their implantation data can be collected prospectively or even retrospectively when available.
Phase 2 - Targeted CS lead placement (RLD subgroup). In the second 200 patients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1. Conventional CS lead placement Phase 2. CS placement guided by RLD measurement
| Arm | Type | Receives |
|---|---|---|
| Conventional CS lead placement | Active comparator | Device: Conventional CS lead placementPatients will be implanted with a CRT device with or without defibrillator (P/D) as per standard clinical practice, without CS lead pacing specific optimization. |
| RLD Group | Experimental | Device: RLD GroupPatients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Be in NYHA II or III functional class with approved class I or II standard indications by ESC/EHRA Guidelines
- Either patients in sinus rhythm or in atrial fibrillation. In this latter case patients must perform AV node ablation if complete biventricular stimulation cannot be achieved in >95% of beats
- Patients willing and able to comply with study requirements(patients must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form)
- Successful LV lead implant
Key exclusion criteria (10 listed)
- Myocardial Infarction, unstable angina within 40 days prior the enrollment
- Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
- Primary valvular disease
- Unable to comply with the follow up schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLD GroupAlso: CRTpatients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold. | Device | RLD Group |
| Conventional CS lead placementAlso: CRTClinical Practice | Device | Conventional CS lead placement |
Primary outcome
Clinical Composite Score -3 months
Time frame: 3 months
Improvement in clinical composite score
1 secondary outcome
Clinical Composite Score-6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 30508076Oddone D, Solari D, Arena G, Mureddu R, Nangah R, Giorgi D, Senatore G, Bottoni N, Giaccardi M, Laffi M, Giammaria M, Sitta N, Marras E, Cipolla E, Di Lorenzo F, Carpi R, Brignole M. Optimization of coronary sinus lead placement targeted to right-to-left delay in patients undergoing cardiac resynchronization therapy. Europace. 2019 Mar 1;21(3):502-510. doi: 10.1093/europace/euy275.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Brignole, MD principal investigator
Ospedale del Tigullio
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RLD Group and Conventional CS lead placement in people with HF Patient, run by Michele Brignole at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Composite Score -3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.