Post Market Surveillance Study Following Clinical RoutineRally CRT-PNCT02488239
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
An observational study of Post Market Surveillance Study Following Clinical Routine, run by Boston Scientific Corporation at 8 sites in 2 countries.
Trial summary
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P devices (CRT-Ps), both in general and specific to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Market Surveillance Study Following Clinical Routine
- What is being tested?
- CRT-P indicated patients
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 8 sitesin 2 countries
- Study dates
- May 2015to Mar 2017
- Phase
- Observational
- 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
Study population: Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device The Ingenio 2 CRT-Ps are indicated for patients who have symptomatic congestive heart failure (CHF) including left ventricular (LV) dysfunction and wide QRS, and/or one or more of the following conditions: Symptomatic paroxysmal or permanent second- or third-degree atrioventricular (AV) block Symptomatic bilateral bundle branch block Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.
Who may be able to join
- 18 years or above, or above legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent
- Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device
- Planned to be implanted with a 3-lead CRT-P system
- Planned to be connected to the remote data collection through the Latitude® system
- Able to do a 6 minute walk test
- Maximum sensor rate of age predicted maximal heart rate (APMHR) 80% should be clinically acceptable
- Willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined-
Who cannot join
- Documented life expectancy of less than 12 months
- Currently on the active heart transplant list
- Enrolled in any other concurrent study without prior written approval from Boston Scientific, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- Schedule of procedures for the Rally CRT-P Study (i.e., should not cause additional or missed visits)
- Rally CRT-P Study outcomes (i.e., involve medications that could affect the heart rate of the subject)
- Conduct of the Rally CRT-P Study per Good Clinical Practice (GCP)/ International Standard Organization (ISO) 14155:2011/ local regulations as applicable
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- In chronic atrial fibrillation
- APMHR needs to be programmed < 80%.
- Not planned to receive a functional atrial lead
- Per the implanting physician's discretion, subject is not a suitable candidate to receive the study device as determined during the implant procedure
- Women of childbearing potential who are or might be pregnant at the time of study enrollment
- Unwilling or unable to participate in all scheduled study follow up visits at an approved study center
- Does not anticipate being a resident of the area for the scheduled duration of the trial. -
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany6 sites
Unfallkrankenhaus Berlin
Berlin, 12683
Herz-und Gefäßzentrum Göttingen
Göttingen, 37073
Krankenhaus Landshut-Achdorf
Landshut, 84036
University Magdeburg
Magdeburg, 39120
Klinikum Oldenburg
Oldenburg, 26133
Harzklinikum Quedlinburg
Quedlinburg, 06484
Finland2 sites
Helsinki University Central Hospital
Helsinki, 00029
Tampere University Hospital
Tampere, 33521
About this study
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P devices (CRT-Ps), both in general and specific to the new features and hardware of the devices.
Read the detailed description
Prospective, non-randomized, multi-center, single group, post market clinical study The devices are fully commercially available and all subjects are planned to receive a CRT-P implant as part of their standard of care (SOC). The assignment of the specific Ingenio 2 device is physician's choice and will consider leads currently in place from previous devices and planned new leads (e.g., Acuity X4 and/or other LV leads).
Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure) (required)
- Implant Procedure (Day 0; all future follow ups based on this date) (required)
- Pre-Discharge Clinic Visit (after pocket closure and wound coverage 0-5 days post-implant procedure) (required)
- 1 month post-implant Clinic Visit (30 ± 15 days) (required)
- 3 month post-implant Clinic Visit (91 ± 21 days) (required)
- Latitude-based Close-out (91 - 120 days months post last enrollment) (reporting only required)
- Unscheduled clinic follow-up (any clinic visit between pre-discharge and 3 month follow up which is in addition to the 1 month follow up; per center SOC or subject needs; event reporting only)
- Re-implant/Revision (as needed)
- During the trial unanticipated serious adverse device effects (USADEs), serious adverse device effects (SADEs), adverse device effects (ADEs), DDs, all serious adverse events (SAEs), deaths, and changes in the device system must be reported (enrollment to Closeout).
Study Duration Enrollment is expected to take 12 months. The study will be considered complete (primary endpoint completion) after all subjects have completed the Latitude based close-out 3-4 months after the last study enrollment. All study required visits will be completed as part of regularly scheduled clinic visits.
- Being tested
- CRT-P indicated patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-P indicated patientsDevice
Also called Pacemaker implant
Patients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device
| Study group | Role | What they receive |
|---|---|---|
| CRT-P indicated patients | Planned to be implanted with a 3-lead CRT-P system and connected to the remote data collection through the Latitude® system Receives: Device: CRT-P indicated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Without CRT-P Device Related Complications
Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device.
Measured: 3 months post-implant
LV Pacing Threshold
Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant.
Measured: 3 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2017
- Study completionMar 2017
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.
- Other trials for Post Market Surveillance Study Following Clinical RoutineStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- S. Pakarinen, Dr., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488239
- Sponsor's protocol ID
- Rally-CRT-P-02-2015
- Acronym
- Rally CRT-P
- Status last verified
- Mar 2019
- First submitted
- 26 Jun 2015
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
- ClinicalTrials.gov ID
- NCT02488239
- Acronym / sponsor ID
- Rally CRT-P / Rally-CRT-P-02-2015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P devices (CRT-Ps), both in general and specific to the new features and hardware of the devices.
Detailed description
Prospective, non-randomized, multi-center, single group, post market clinical study The devices are fully commercially available and all subjects are planned to receive a CRT-P implant as part of their standard of care (SOC). The assignment of the specific Ingenio 2 device is physician's choice and will consider leads currently in place from previous devices and planned new leads (e.g., Acuity X4 and/or other LV leads).
Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure) (required)
- Implant Procedure (Day 0; all future follow ups based on this date) (required)
- Pre-Discharge Clinic Visit (after pocket closure and wound coverage 0-5 days post-implant procedure) (required)
- 1 month post-implant Clinic Visit (30 ± 15 days) (required)
- 3 month post-implant Clinic Visit (91 ± 21 days) (required)
- Latitude-based Close-out (91 - 120 days months post last enrollment) (reporting only required)
- Unscheduled clinic follow-up (any clinic visit between pre-discharge and 3 month follow up which is in addition to the 1 month follow up; per center SOC or subject needs; event reporting only)
- Re-implant/Revision (as needed)
- During the trial unanticipated serious adverse device effects (USADEs), serious adverse device effects (SADEs), adverse device effects (ADEs), DDs, all serious adverse events (SAEs), deaths, and changes in the device system must be reported (enrollment to Closeout).
Study Duration Enrollment is expected to take 12 months. The study will be considered complete (primary endpoint completion) after all subjects have completed the Latitude based close-out 3-4 months after the last study enrollment. All study required visits will be completed as part of regularly scheduled clinic visits.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT-P indicated patients | – | Device: CRT-P indicated patientsPlanned to be implanted with a 3-lead CRT-P system and connected to the remote data collection through the Latitude® system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device The Ingenio 2 CRT-Ps are indicated for patients who have symptomatic congestive heart failure (CHF) including left ventricular (LV) dysfunction and wide QRS, and/or one or more of the following conditions: Symptomatic paroxysmal or permanent second- or third-degree atrioventricular (AV) block Symptomatic bilateral bundle branch block Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.
Key inclusion criteria (8 listed)
- 18 years or above, or above legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent
- Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device
- Planned to be implanted with a 3-lead CRT-P system
- Planned to be connected to the remote data collection through the Latitude® system
Key exclusion criteria (13 listed)
- Documented life expectancy of less than 12 months
- Currently on the active heart transplant list
- Enrolled in any other concurrent study without prior written approval from Boston Scientific, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- In chronic atrial fibrillation
- APMHR needs to be programmed < 80%.
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 |
|---|---|---|
| CRT-P indicated patientsAlso: Pacemaker implantPatients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device | Device | CRT-P indicated patients |
Primary outcome
Percentage of Participants Without CRT-P Device Related Complications
Time frame: 3 months post-implant
Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device.
LV Pacing Threshold
Time frame: 3 months post-implant
Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
S. Pakarinen, Dr. principal investigator
Helsinki University Central Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Market Surveillance Study Following Clinical Routine, run by Boston Scientific Corporation at 8 sites in 2 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 13 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Finland. 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 Sep 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 Participants Without CRT-P Device Related Complications (time frame: 3 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2019.