Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) BlockNCT01700244
Evaluation of a New Cardiac Pacemaker
A study testing Pacemaker implant in people with Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block and Normal Sinus Rhythm With 2 or 3° AV or BBB Block, run by Nanostim, Inc. at 8 sites in 3 countries.
Trial summary
An evaluation of a safety and performance of a new cardiac pacemaker Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block, Normal Sinus Rhythm With 2 or 3° AV or BBB Block, Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings
- What is being tested?
- Pacemaker implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Dec 2012to Aug 2013
- 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
- Subject must have one of the following clinical indications:
- Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or
- Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
- Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
- Subject ≥18 years of age;
- Subject has life expectancy of at least one year;
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- Subject is not enrolled in another clinical investigation;
- Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC;
- If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.
Who cannot join
- Pacemaker dependent;
- Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
- Hypersensitivity to < 1 mg of dexamethasone sodium phosphate;
- Mechanical tricuspid valve prosthesis;
- Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease;
- Pre-existing pacing or defibrillation leads;
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- Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT);
- Presence of implanted vena cava filter;
- Presence of implanted leadless cardiac pacemaker;
- Pregnant or breastfeeding.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany3 sites
Kerckhoff Clinic
Bad Nauheim, 61231
University Hospital Leipzig
Leipzig, 04103
Heart Hospital Munich
Munich, 80636
Netherlands3 sites
Academic Medical Center
Amsterdam, 1105
St. Antonius Hospital
Nieuwegein, 3430
UMC Utrecht
Utrecht, 3584
About this study
An evaluation of a safety and performance of a new cardiac pacemaker
- Conditions
- Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block, Normal Sinus Rhythm With 2 or 3° AV or BBB Block, Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings
- Being tested
- Pacemaker implant
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker | Experimental | Not described Receives: Device: Pacemaker implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate, where a complication is defined as a serious adverse device effect (SADE)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanostim, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Sperzel, MD, Principal investigator, Kerckhoff Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700244
- Sponsor's protocol ID
- LCP004
- Status last verified
- Jun 2013
- First submitted
- 2 Oct 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.
PubMed 27932427Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.
PubMed 25881930Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.
PubMed 24664277
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Cardiac Pacemaker
- ClinicalTrials.gov ID
- NCT01700244
- Acronym / sponsor ID
- LCP004
- Conditions
- Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block, Normal Sinus Rhythm With 2 or 3° AV or BBB Block, Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nanostim, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 4 Oct 2012 (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.
An evaluation of a safety and performance of a new cardiac pacemaker
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker | Experimental | Device: Pacemaker implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must have one of the following clinical indications:
- Subject ≥18 years of age;
- Subject has life expectancy of at least one year;
- Subject is not enrolled in another clinical investigation;
- Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
Key exclusion criteria (10 listed)
- Pacemaker dependent;
- Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
- Hypersensitivity to < 1 mg of dexamethasone sodium phosphate;
- Mechanical tricuspid valve prosthesis;
- Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease;
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 |
|---|---|---|
| Pacemaker implant | Device | Pacemaker |
Primary outcome
Complication rate, where a complication is defined as a serious adverse device effect (SADE)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
- Derived from this study: PubMed 27932427Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.
- Derived from this study: PubMed 25881930Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.
- Derived from this study: PubMed 24664277Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.
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.
Johannes Sperzel, MD principal investigator
Kerckhoff Clinic
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implant in people with Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block and Normal Sinus Rhythm With 2 or 3° AV or BBB Block, run by Nanostim, Inc. at 8 sites in 3 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 10 inclusion and 10 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 26 Jun 2013. 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, Netherlands, Czechia. 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?
Complication rate, where a complication is defined as a serious adverse device effect (SADE) (time frame: 90 days). 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 NCT01700244, which also lists 3 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 26 Jun 2013; AzTrials last refreshed its copy on 30 Oct 2026.