UnknownNot Applicable

Evaluation of a New Cardiac Pacemaker

Czechia, Germany36 participantsStarted 2012-12

Plain-language summary

An evaluation of a safety and performance of a new cardiac pacemaker

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

Complication rate, where a complication is defined as a serious adverse device effect (SADE)

Timeframe: 90 days

NCT IDNCT01700244

SponsorNanostim, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07