Right Bundle-Branch BlockSPARKNCT02441101

Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)

A study testing RV DDD(R)-60 with AV optimization and RV DDD(R)-60 in people with Right Bundle-Branch Block and Heart Failure, run by Barry London at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Right Bundle-Branch Block, Heart Failure
What is being tested?: RV DDD(R)-60 with AV optimization and RV DDD(R)-60
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2016to 11 Feb 2020
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

Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months.
LVEF < 35% by trans-thoracic echocardiogram assessment
Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities*
Normal sinus rhythm at enrollment
RBBB with QRS duration >120 msec on 12 lead surface EKG.
PR interval <250 msec on 12 lead surface EKG
Subjects with biventricular pacemaker/ICD will be eligible for enrollment if their LV lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the LV pacing therapy for any reason per primary cardiologist discretion)

Who cannot join

Age younger than 18 years old
Pregnancy
Acute Myocardial infarction within 6 months of entry into the study
Inotrope dependent heart failure condition
Left ventricular assist device or heart transplantation
Any other known conditions other than heart failure that could limit survival to < 6 months.
Atrial fibrillation or flutter burden >10% of the time within the last 6 months
Atrioventricular node disease that requires ventricular pacemaker support >10% of the time

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)

This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.

Read the detailed description

This pilot clinical trial will be a randomized single blinded cross over trial. Each subject will undergo three study stages. Subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. In the second stage, both arms transition to a two months, intervention free, wash out period. Finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.

Conditions: Right Bundle-Branch Block, Heart Failure
Being tested: RV DDD(R)-60 with AV optimization, RV DDD(R)-60
Keywords: Cardiac Resynchronization therapy
Medical subject headings: Bundle-Branch Block, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RV DDD(R)-60 with AV optimizationDevice
Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG
RV DDD(R)-60Device
AV settings programmed to minimize RV pacing - standard demand pacing programming.

Study groups in NCT02441101
Study group	Role	What they receive
RV pacing optimization on/off	Experimental	RBBB pacing Arm 1 is RV pacing optimization on/off Receives: Device: RV DDD(R)-60 with AV optimization
RV pacing optimization off/on	Placebo comparator	Standard demand pacing Arm 2 is RV pacing optimization off/on Receives: Device: RV DDD(R)-60

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of LV Ejection Fraction Compared to Baseline
LV Ejection Fraction is defined as [(end diastolic volume minus end systolic volume) / (end diastolic volume] as measured by echocardiography.
Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off.
Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on
Measured: Baseline to 3 months

Secondary outcomes (1)

Electrocardiographic: QRS Duration
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201611 Feb 2020

First posted12 May 2015 (estimated)
Study start1 Feb 2016
Primary completion11 Feb 2020
Study completion11 Feb 2020

Why it stopped: PI left the institution

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 Right Bundle-Branch 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02441101
Sponsor's protocol ID: 201409760
Acronym: SPARK
Status last verified: May 2024
First submitted: 6 May 2015
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Left Bundle Branch Area Pacing, Right Ventricular Pacing
Active, not recruiting
Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction
Atrioventricular Block, Left Bunde Branch Area Pacing
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
RecruitingObservational study
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Active, not recruiting
Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block
Atrioventricular Block

All Right Bundle-Branch Block trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)
ClinicalTrials.gov ID: NCT02441101
Acronym / sponsor ID: SPARK / 201409760
Conditions: Right Bundle-Branch Block, Heart Failure
Keywords: Cardiac Resynchronization therapy
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI left the institution
Enrolment: 6 participants (actual)
Lead sponsor: Barry LondonUniversity, hospital or other
Study start: 1 Feb 2016 (actual)
Primary completion: 11 Feb 2020 (actual)
Study completion: 11 Feb 2020 (actual)
First posted: 12 May 2015 (estimated)
Results: Posted 18 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
RV pacing optimization on/off	Experimental	Device: RV DDD(R)-60 with AV optimizationRBBB pacing Arm 1 is RV pacing optimization on/off
RV pacing optimization off/on	Placebo comparator	Device: RV DDD(R)-60Standard demand pacing Arm 2 is RV pacing optimization off/on

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months.
LVEF < 35% by trans-thoracic echocardiogram assessment
Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities*
Normal sinus rhythm at enrollment
RBBB with QRS duration >120 msec on 12 lead surface EKG.

Key exclusion criteria (8 listed)

Age younger than 18 years old
Pregnancy
Acute Myocardial infarction within 6 months of entry into the study
Inotrope dependent heart failure condition
Left ventricular assist device or heart transplantation

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
RV DDD(R)-60 with AV optimizationDevice to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG	Device	RV pacing optimization on/off
RV DDD(R)-60AV settings programmed to minimize RV pacing - standard demand pacing programming.	Device	RV pacing optimization off/on

Primary outcome

Change of LV Ejection Fraction Compared to Baseline
Time frame: Baseline to 3 months
LV Ejection Fraction is defined as [(end diastolic volume minus end systolic volume) / (end diastolic volume] as measured by echocardiography. Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off. Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on

1 secondary outcome

Electrocardiographic: QRS Duration
Time frame: Baseline to 3 months

Results and safety

Results posted to the registry on 18 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RV Pacing Optimization on First, Then Off	4	1
RV Pacing Optimization Off First, Then on	2	2

Primary outcome: Change of LV Ejection Fraction Compared to Baseline

Time frame: Baseline to 3 months. Mean (Standard Deviation). Unit: Percent

Measure	RV Pacing Optimization on n = 6	RV Pacing Optimization Off n = 3
Value	0 (4)	4 (7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events and Serious Adverse Events were collected during enrollment period, up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RV Pacing Optimization on	0 of 4 (0%)	0 of 4 (0%)	0 of 4
RV Pacing Optimization Off	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Right Bundle-Branch Block

Recruiting
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Left Bundle Branch Area Pacing, Right Ventricular Pacing
Active, not recruiting
Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction
Atrioventricular Block, Left Bunde Branch Area Pacing
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
RecruitingObservational study
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Active, not recruiting
Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block
Atrioventricular Block

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.

Michael C Giudici, MD study chair

University of Iowa

Michael C Giudici, MD principal investigator

University of Iowa

Shubba D Roy, MD principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RV DDD(R)-60 with AV optimization and RV DDD(R)-60 in people with Right Bundle-Branch Block and Heart Failure, run by Barry London at 1 site in United States.

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 7 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: stopped early, as of the sponsor's last update on 18 Jun 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 18 Jun 2024). 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?

Change of LV Ejection Fraction Compared to Baseline (time frame: Baseline to 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 NCT02441101.

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 18 Jun 2024.