Heart FailureALSYNCNCT01277783
ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
A study testing Endocardial Left Ventricular pacing in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 18 sites in 7 countries.
Trial summary
The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation. The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the… 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?
- Endocardial Left Ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 18 sitesin 7 countries
- Study dates
- Mar 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cardiac Resynchronization Therapy candidate/recipient with:
- Failed Cardiac Resynchronization Therapy implant or required CRT replacement without viable access to Coronary sinus or,
- Sub-optimal Coronary sinus anatomy per investigator discretion or,
- Worsened or unchanged clinical status after Cardiac Resynchronization Therapy implant
- Patients able and willing to take optimal Vitamin K antagonist therapy (International Normalized Ratio (INR) of 2-4)
- Patients willing to sign and date the Patient Informed Consent form
- Patients 18 years of age or older
- Patients able and willing to comply with the protocol, and is expected to remain available for follow-up visits
Who cannot join
- Patients having contraindications to Vitamin K antagonist therapy
- Patients contraindicated for < 100 micrograms beclomethasone dipropionate
- Patients unable to tolerate an urgent thoracotomy
- Documented (previous) ischemic or hemorrhagic stroke
- Patients with known previous atrial septal defect closure, or history of mural thrombus that has not been resolved
- Patients with documented atrial fibrillation AND increased stroke risk as determined by the Congestive Heart Failure, Hypertension, Age(2), Diabetes, Stroke(2), Vascular disease, Age, and Sex Category (CHA2DS2-VASc) Score of equal to or greater than 5
Show all 19Show fewer
- Patients with unstable angina pectoris or who have had an acute myocardial infarct within the past 30 days
- Patients with known atrial septum defect (ASD) and/or left superior vena cava
- Patient with known internal carotid artery stenosis of greater than 50%
- Patients diagnosed with peripheral artery disease that are expected to undergo stenting within the next three months
- Patients who have had a Coronary artery bypass graft or stent within the past three months
- Patients with history of mitral or aortic valve repair or replacement
- Post heart transplant patients (patients waiting for heart transplant are allowed in the study)
- Patients currently undergoing dialysis treatment
- Patients with ongoing chemotherapy and radiation therapy that may have an effect on cardiac function
- Patients with ongoing Adverse Events from a previous Left Ventricle lead implant attempt
- Patients enrolled in any concurrent drug and/or device study that may confound the results of this study
- Patients who are not expected to survive more than twelve months
- Patients with exclusion criteria required by local law
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
France5 sites
Hôpital Haut-Lévêque - CHU de Bordeaux
Bordeaux
CHU Grenoble Hôpital Michalon
Grenoble
Infirmerie Protestante de Lyon
Lyon
Nouvelles Cliniques Nantaises
Nantes
Hôpital Pontchaillou - CHU de Rennes
Rennes
United Kingdom4 sites
Royal Victoria Hospital
Belfast
Golden Jubilee National Hospital
Glasgow
University College London Hospitals NHS Foundation Trust - The Heart Hospital
London
Southampton General Hospital
Southhampton
Italy3 sites
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi
Bologna
Presidio Ospedaliero Alessandro Manzoni
Lecco
Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri
Roma
Belgium2 sites
AZ Sint-Jan - Campus Sint-Jan
Bruges
Centre Hospitalier Regional de la Citadelle
Liège
Canada2 sites
London Health Sciences Centre - University Campus
London, Ontario
Saint Paul's Hospital
Vancouver, British Columbia
About this study
Official title: ALternate Site Cardiac ReSYNChronization Study
The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation.
The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle.
Read the detailed description
Cardiac resynchronization therapy (CRT) reduces mortality and the risk of heart failure decompensation and improves quality of life in indicated patients. However, many do not benefit due to failure to deliver the left ventricular (LV) lead via coronary sinus (5-10%) or lack of symptomatic improvement (30-40%).
The purpose of the ALSYNC Study was to evaluate the feasibility and safety of LV endocardial (LVE) pacing using a Model 3830 lead implanted by a novel pectoral atrial transseptal lead delivery system.
- Conditions
- Heart Failure
- Being tested
- Endocardial Left Ventricular pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocardial Left Ventricular pacingDevice
Subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter, using trans esophageal echo (TEE) or intra-cardiac echo (ICE) to guide the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Endocardial Left Ventricular pacing | Experimental | All patients will undergo the intervention, and are followed at 1, 3, 6, and 12 months (minimum) and biannually thereafter until 1 year after enrollment of the last patient. Receives: Device: Endocardial Left Ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Free From Lead, Delivery System and Implant Related Complications.
Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval.
Measured: 6 months
Secondary outcomes (12)
Implant Success
Number of participants with a successful implant of Model 3830 lead.
Measured: Implant
Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor
Questionaires were collected for each LV lead implant attempt, reattempt, and LV lead modification. To evaluate the ease of positioning of the Model 3830 lead and the Models 6227ATS and 6248HS, JS, JL catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent was used for each of the ten questions on the questionnaire. Outcome reports the number of questionnaires where no single question was answered with Poor.
Measured: Implant
Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months
Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit.
Measured: 12 months
Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months
Bipolar measurement of Model 3830 lead voltage threshold at 0.4ms pulse width using the implanted device at the 12 month visit
Measured: 12 months
Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months
Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit
Measured: 12 months
Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months
NYHA Class change was evaluated between baseline and the 6 months visit. Reported are the subjects with at least 1 class improvement from baseline to 6 months
Measured: baseline and 6 months
Distance Walked at 6 Minute Hall Walk at the 12 Month Visit
Distance walked at the 6 minute hall walk test at the 12 month visit
Measured: 12 months
Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months
Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months
Measured: baseline and 6 months
Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months
Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months
Measured: 6 months
Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months
Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months
Measured: baseline and 6 months
Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months
Reported is the number of patients with at least one class improvement from baseline to 6 months
Measured: baseline and 6 months
Change in (NT-pro)BNP Levels From Baseline to 6 Months
Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor John Morgan, MD, Principal investigator, Spire Southampton Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277783
- Sponsor's protocol ID
- ALSYNC
- Acronym
- ALSYNC
- Status last verified
- Mar 2019
- First submitted
- 11 Jan 2011
- Last updated
- 20 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Biffi M, Defaye P, Jais P, Ruffa F, Leclercq C, Gras D, Yang Z, Gerritse B, Ziacchi M, Morgan JM; ALSYNC Investigators. Benefits of left ventricular endocardial pacing comparing failed implants and prior non-responders to conventional cardiac resynchronization therapy: A subanalysis from the ALSYNC study. Int J Cardiol. 2018 May 15;259:88-93. doi: 10.1016/j.ijcard.2018.01.030.
PubMed 29579617Morgan JM, Biffi M, Geller L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18.
PubMed 26787437
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALternate Site Cardiac ReSYNChronization Study
- ClinicalTrials.gov ID
- NCT01277783
- Acronym / sponsor ID
- ALSYNC / ALSYNC
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Posted 20 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation.
The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle.
Detailed description
Cardiac resynchronization therapy (CRT) reduces mortality and the risk of heart failure decompensation and improves quality of life in indicated patients. However, many do not benefit due to failure to deliver the left ventricular (LV) lead via coronary sinus (5-10%) or lack of symptomatic improvement (30-40%).
The purpose of the ALSYNC Study was to evaluate the feasibility and safety of LV endocardial (LVE) pacing using a Model 3830 lead implanted by a novel pectoral atrial transseptal lead delivery system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocardial Left Ventricular pacing | Experimental | Device: Endocardial Left Ventricular pacingAll patients will undergo the intervention, and are followed at 1, 3, 6, and 12 months (minimum) and biannually thereafter until 1 year after enrollment of the last patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cardiac Resynchronization Therapy candidate/recipient with:
- Failed Cardiac Resynchronization Therapy implant or required CRT replacement without viable access to Coronary sinus or,
- Sub-optimal Coronary sinus anatomy per investigator discretion or,
- Worsened or unchanged clinical status after Cardiac Resynchronization Therapy implant
- Patients able and willing to take optimal Vitamin K antagonist therapy (International Normalized Ratio (INR) of 2-4)
Key exclusion criteria (19 listed)
- Patients having contraindications to Vitamin K antagonist therapy
- Patients contraindicated for < 100 micrograms beclomethasone dipropionate
- Patients unable to tolerate an urgent thoracotomy
- Documented (previous) ischemic or hemorrhagic stroke
- Patients with known previous atrial septal defect closure, or history of mural thrombus that has not been resolved
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 |
|---|---|---|
| Endocardial Left Ventricular pacingSubjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter, using trans esophageal echo (TEE) or intra-cardiac echo (ICE) to guide the procedure. | Device | Endocardial Left Ventricular pacing |
Primary outcome
Percentage of Patients Free From Lead, Delivery System and Implant Related Complications.
Time frame: 6 months
Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval.
12 secondary outcomes
Implant Success
Time frame: Implant
Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor
Time frame: Implant
Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months
Time frame: 12 months
Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months
Time frame: 12 months
Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months
Time frame: 12 months
Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months
Time frame: baseline and 6 months
Distance Walked at 6 Minute Hall Walk at the 12 Month Visit
Time frame: 12 months
Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months
Time frame: baseline and 6 months
Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months
Time frame: 6 months
Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months
Time frame: baseline and 6 months
Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months
Time frame: baseline and 6 months
Change in (NT-pro)BNP Levels From Baseline to 6 Months
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29579617Biffi M, Defaye P, Jais P, Ruffa F, Leclercq C, Gras D, Yang Z, Gerritse B, Ziacchi M, Morgan JM; ALSYNC Investigators. Benefits of left ventricular endocardial pacing comparing failed implants and prior non-responders to conventional cardiac resynchronization therapy: A subanalysis from the ALSYNC study. Int J Cardiol. 2018 May 15;259:88-93. doi: 10.1016/j.ijcard.2018.01.030.
- Derived from this study: PubMed 26787437Morgan JM, Biffi M, Geller L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18.
- 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.
Professor John Morgan, MD principal investigator
Spire Southampton Hospital
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocardial Left Ventricular pacing in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 18 sites in 7 countries.
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 8 inclusion and 19 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, United Kingdom, Italy, Belgium, Canada and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. (time frame: 6 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 NCT01277783, which also lists 2 linked publications.
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 20 Jun 2019.