Heart FailureNCT04632472
Targeted Left Ventricular Lead Placement, Comparison of Active Fixation Bipolar and Passive Quadripolar Pacemaker Leads
A study testing Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy in people with Heart Failure, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads. The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- 15 Feb 2016to 31 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left Ventricular Ejection Fraction (LVEF) ≤ 35 %
- NYHA 2-4
- Electrocardiogram : left bundle branch block (LBBB) and QRS duration >120 ms or non-LBBB and QRS duration ≥150 ms
- Optimal medical treatment.
Who cannot join
- Upgrade procedures due to ventricular pacing
- No written consensus
Trial locations and contacts
1 site in 1 country.
Norway1 site
Haukeland University Hospital, Department of Heart Disease
Bergen, 5021
About this study
Official title: Targeted Left Ventricular Lead Placement for Cardiac Resynchronization Therapy, a Randomized Trial Comparing an Active Fixation Bipolar Left Ventricular Lead and Passive Fixation Quadripolar Leads
A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads. The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The patients were followed up for 12 months.
Read the detailed description
A prospective, randomized and patient-blinded trial. The objective was to compare an active fixation left ventricular lead with quadripolar passive left ventricular leads. The left ventricular segment with latest mechanical activation was identified as target segment by radial strain speckle-tracking echocardiography.The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The clinical outcomes were assessed by echocardiography, change in New York Heart Association (NYHA) functional class and Minnesota Living With Heart Failure Questionnaire (MLHFQ). The patients were followed up for 12 months.
- Conditions
- Heart Failure
- Being tested
- Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
- Keywords
- Cardiac Resynchronization therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization TherapyDevice
Cardiac resynchronization therapy trial comparing types of leads.
| Study group | Role | What they receive |
|---|---|---|
| Active fixation bipolar lead | Active comparator | Left ventricular bipolar pacemaker lead, fixated by a side helix Receives: Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy |
| Passive fixation quadripolar lead | Placebo comparator | Left ventricular quadripolar passive fixation pacemaker lead Receives: Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic response
Changes in left ventricular end-systolic volume (measured in milliliter).
Measured: Day 0 (baseline). 6 and 12 months after implantation
Ability to achieve a position in a coronary vein located concordant to target segment.
The left ventricular lead final position will be compared to the left ventricular target segment. The target segment is determined by radial strain speckle-tracking echocardiography. The lead position is classified as "concordant" or "not concordant".
Measured: At implant (day 0)
The left ventricular lead long-axis position.
Measurement of the distance (millimeter) from the active electrode to coronary sinus. Fluoroscopic measurement in a right anterior oblique (RAO) view.
Measured: At implant (day 0)
The left ventricular lead pacing threshold
Changes in left ventricular lead pacing capture thresholds, measured in "Volt" with 0.4ms pulse width.
Measured: Day 0 (baseline). 2, 6 and 12 months after implantation.
Secondary outcomes (4)
Changes in NYHA functional Class
Assessment of NYHA functional Class. Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms. Class IV - Severe limitations, symptoms even while at rest.
Measured: Day 0 (baseline). 2, 6 and 12 months after implantation
Changes in MLHFQ score
Evaluating Quality of Life. 21 questions with total scores ranging from 0 to 105. A higher score means a worse outcome.
Measured: Day 0 (baseline). 2, 6 and 12 months after implantation
Left ventricular lead impedances
Changes in left ventricular pacing impedances, measured in "Ohm".
Measured: Day 0 (baseline). 2, 6 and 12 months after implantation
Changes in left ventricular ejection fraction
Changes in left ventricular ejection fraction (unit:"percent") measured by echocardiography
Measured: Day 0 (baseline). 6 and 12 months after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start15 Feb 2016
- Primary completion31 Oct 2018
- Study completion31 Oct 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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632472
- Sponsor's protocol ID
- 2015/1507
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keilegavlen H, Schuster P, Hovstad T, Faerestrand S. Clinical outcome of cardiac resynchronization therapy in patients randomized to an active fixation bipolar left ventricular lead versus a passive quadripolar lead. Scand Cardiovasc J. 2021 Jun;55(3):153-159. doi: 10.1080/14017431.2020.1869299. Epub 2021 Jan 10.
PubMed 33426938
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Left Ventricular Lead Placement for Cardiac Resynchronization Therapy, a Randomized Trial Comparing an Active Fixation Bipolar Left Ventricular Lead and Passive Fixation Quadripolar Leads
- ClinicalTrials.gov ID
- NCT04632472
- Acronym / sponsor ID
- 2015/1507
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 17 Nov 2020 (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.
A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads. The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The patients were followed up for 12 months.
Detailed description
A prospective, randomized and patient-blinded trial. The objective was to compare an active fixation left ventricular lead with quadripolar passive left ventricular leads. The left ventricular segment with latest mechanical activation was identified as target segment by radial strain speckle-tracking echocardiography.The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The clinical outcomes were assessed by echocardiography, change in New York Heart Association (NYHA) functional class and Minnesota Living With Heart Failure Questionnaire (MLHFQ). The patients were followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active fixation bipolar lead | Active comparator | Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization TherapyLeft ventricular bipolar pacemaker lead, fixated by a side helix |
| Passive fixation quadripolar lead | Placebo comparator | Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization TherapyLeft ventricular quadripolar passive fixation pacemaker lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Left Ventricular Ejection Fraction (LVEF) ≤ 35 %
- NYHA 2-4
- Electrocardiogram : left bundle branch block (LBBB) and QRS duration >120 ms or non-LBBB and QRS duration ≥150 ms
- Optimal medical treatment.
Key exclusion criteria (2 listed)
- Upgrade procedures due to ventricular pacing
- No written consensus
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 |
|---|---|---|
| Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization TherapyCardiac resynchronization therapy trial comparing types of leads. | Device | Active fixation bipolar lead, Passive fixation quadripolar lead |
Primary outcome
Echocardiographic response
Time frame: Day 0 (baseline). 6 and 12 months after implantation
Changes in left ventricular end-systolic volume (measured in milliliter).
Ability to achieve a position in a coronary vein located concordant to target segment.
Time frame: At implant (day 0)
The left ventricular lead final position will be compared to the left ventricular target segment. The target segment is determined by radial strain speckle-tracking echocardiography. The lead position is classified as "concordant" or "not concordant".
The left ventricular lead long-axis position.
Time frame: At implant (day 0)
Measurement of the distance (millimeter) from the active electrode to coronary sinus. Fluoroscopic measurement in a right anterior oblique (RAO) view.
The left ventricular lead pacing threshold
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation.
Changes in left ventricular lead pacing capture thresholds, measured in "Volt" with 0.4ms pulse width.
4 secondary outcomes
Changes in NYHA functional Class
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation
Changes in MLHFQ score
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation
Left ventricular lead impedances
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation
Changes in left ventricular ejection fraction
Time frame: Day 0 (baseline). 6 and 12 months after implantation.
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 17 Nov 2020.
- Derived from this study: PubMed 33426938Keilegavlen H, Schuster P, Hovstad T, Faerestrand S. Clinical outcome of cardiac resynchronization therapy in patients randomized to an active fixation bipolar left ventricular lead versus a passive quadripolar lead. Scand Cardiovasc J. 2021 Jun;55(3):153-159. doi: 10.1080/14017431.2020.1869299. Epub 2021 Jan 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy in people with Heart Failure, run by Haukeland University Hospital at 1 site in Norway.
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 2 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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. Some participants in this study may receive a placebo. 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?
Echocardiographic response (time frame: Day 0 (baseline). 6 and 12 months after implantation). The study lists 4 primary outcomes in all. 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 NCT04632472, 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 17 Nov 2020.