Heart BlockRASPNCT00199498
Right Apical Versus Septal Pacing Trial
A study testing Apical RV lead placement and Septal RV lead placement in people with Heart Block and Heart Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Block, Heart Failure
- What is being tested?
- Apical RV lead placement and Septal RV lead placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Dec 2016
- 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
- a)Fixed (third degree) AV block b) Atrial Fibrillation with average Ventricular rate on ECG </= 40bpm or mean heart rate on Holter monitor </= 60bpm c) Sinus node Dysfunction with PR interval >/= 300msec d) Paroxysmal, persistent or permanent AF undergoing AV node , AV node/HIS ablation e) 2°AV Block with ≥3:1 block
- the subject is 18 years of age or older
- the subject has provided written consent -
Who cannot join
- Pre-existing permanent cardiac pacemaker or ICD (defibrillator)
- Presence of Hypertrophic Obstructive Cardiomyopathy
- Recent cardiac surgery (</= 30 days)
- Recent myocardial infarction (</= 30 days)
- Presence of mechanical prosthetic tricuspid valve
- Patient inability or unwillingness to comply with study protocol and required study visit schedule
- Concomitant research study whose protocol would conflict or affect the outcome of this study
- Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing.
Read the detailed description
The primary objective of this study is to compare the effect of RV pacing site on LV systolic function as measured by LVEF (left ventricular ejection fraction).
Secondary objectives of this trial include:
- to compare the effect of RVSeptal(RVS) versus RVApical(RVA)pacing on other indices of systolic and diastolic LV function
- to compare the rate of heart failure-related hospitalization between RVS versus RVA pacing
- to compare new-onset atrial fibrillation and stroke rates between RVS versus RVA pacing
- to assess the effect of RVA versus RVS pacing on quality of life and functional capacity
- to compare the rate of successful pacemaker lead implantation, complications and chronic electrical performance of RVS versus RVA pacing
- Conditions
- Heart Block, Heart Failure
- Being tested
- Apical RV lead placement, Septal RV lead placement
- Keywords
- Permanent Pacemaker Implantation- Lead Position
- Medical subject headings
- Heart Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apical RV lead placementDevice
RV lead implanted ( according to randomization )at the apex
Septal RV lead placementDevice
RV lead is implanted (according to randomization), on septum
| Study group | Role | What they receive |
|---|---|---|
| Septal RV lead placement | Experimental | patient randomized to Septal RV lead placement Receives: Device: Septal RV lead placement |
| Apical RV lead placement | Active comparator | patient randomized to Apical RV lead placement (current standard placement) Receives: Device: Apical RV lead placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV ejection fraction measured by radionuclide ventriculography (RVG).
Measured: 2 weeks, 24 months and 36 months
Secondary outcomes (9)
Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).
Measured: 36 months
All cause mortality.
Measured: 36 months
Non-fatal thromboembolic events including stroke.
Measured: 36 months
Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic.
Measured: 36 months
Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation.
Measured: 36 months
Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores.
Measured: 2 weeks, 24 and 36 months
NYHA class using SAS survey, 6 minute hall walk distance.
Measured: 2 weeks, 24 and 36 months
lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold
Measured: 2 weeks, 24 and 36 months
total implant procedure and fluoroscopy time
Measured: Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart BlockStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Raymond Yee, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Raymond Yee, MD FRCPC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199498
- Sponsor's protocol ID
- R-04-399
- Other IDs
- HSREB # 10880
- Acronym
- RASP
- Status last verified
- Apr 2016
- First submitted
- 13 Sep 2005
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Apical Versus Septal Pacing Trial
- ClinicalTrials.gov ID
- NCT00199498
- Acronym / sponsor ID
- RASP / R-04-399
- Conditions
- Heart Block, Heart Failure
- Keywords
- Permanent Pacemaker Implantation- Lead Position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Apr 2005
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- 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.
The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing.
Detailed description
The primary objective of this study is to compare the effect of RV pacing site on LV systolic function as measured by LVEF (left ventricular ejection fraction).
Secondary objectives of this trial include:
- to compare the effect of RVSeptal(RVS) versus RVApical(RVA)pacing on other indices of systolic and diastolic LV function
- to compare the rate of heart failure-related hospitalization between RVS versus RVA pacing
- to compare new-onset atrial fibrillation and stroke rates between RVS versus RVA pacing
- to assess the effect of RVA versus RVS pacing on quality of life and functional capacity
- to compare the rate of successful pacemaker lead implantation, complications and chronic electrical performance of RVS versus RVA pacing
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septal RV lead placement | Experimental | Device: Septal RV lead placementpatient randomized to Septal RV lead placement |
| Apical RV lead placement | Active comparator | Device: Apical RV lead placementpatient randomized to Apical RV lead placement (current standard placement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a)Fixed (third degree) AV block b) Atrial Fibrillation with average Ventricular rate on ECG </= 40bpm or mean heart rate on Holter monitor </= 60bpm c) Sinus node Dysfunction with PR interval >/= 300msec d) Paroxysmal, persistent or permanent AF undergoing AV node , AV node/HIS ablation e) 2°AV Block with ≥3:1 block
- the subject is 18 years of age or older
- the subject has provided written consent -
Key exclusion criteria (8 listed)
- Pre-existing permanent cardiac pacemaker or ICD (defibrillator)
- Presence of Hypertrophic Obstructive Cardiomyopathy
- Recent cardiac surgery (</= 30 days)
- Recent myocardial infarction (</= 30 days)
- Presence of mechanical prosthetic tricuspid valve
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 |
|---|---|---|
| Apical RV lead placementRV lead implanted ( according to randomization )at the apex | Device | Apical RV lead placement |
| Septal RV lead placementRV lead is implanted (according to randomization), on septum | Device | Septal RV lead placement |
Primary outcome
LV ejection fraction measured by radionuclide ventriculography (RVG).
Time frame: 2 weeks, 24 months and 36 months
9 secondary outcomes
Left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP).
Time frame: 36 months
All cause mortality.
Time frame: 36 months
Non-fatal thromboembolic events including stroke.
Time frame: 36 months
Heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic.
Time frame: 36 months
Occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation.
Time frame: 36 months
Symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores.
Time frame: 2 weeks, 24 and 36 months
NYHA class using SAS survey, 6 minute hall walk distance.
Time frame: 2 weeks, 24 and 36 months
lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold
Time frame: 2 weeks, 24 and 36 months
total implant procedure and fluoroscopy time
Time frame: Implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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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.
Raymond Yee, MD FRCPC principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apical RV lead placement and Septal RV lead placement in people with Heart Block and Heart Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Apr 2016. 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 Canada. 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?
Results are not available in the source record.
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?
LV ejection fraction measured by radionuclide ventriculography (RVG). (time frame: 2 weeks, 24 months and 36 months). 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 13 Apr 2016.