Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Public ClinicalTrials.gov record NCT01534234. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software. This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method. This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.
Study identification
- NCT ID
- NCT01534234
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,039 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2012 (Type not available)
- Primary completion
- Dec 2015 (Actual)
- Completion
- Dec 2019 (Estimated)
- Last update posted
- Jan 11, 2019
2012 – 2019
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Brookwood Medical Center CardioVascular Associates | Birmingham | Alabama | 35243 | — |
| AZ Heart Rhythm Center | Phoenix | Arizona | 85016 | — |
| Brotman Medical Center | Culver City | California | 90232 | — |
| Hoag Hospital | Newport Beach | California | 92663 | — |
| Scripps Mercy Hospital | San Diego | California | 92942 | — |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | — |
| St. Vincent's HealthCare | Jacksonville | Florida | 32204 | — |
| Piedmont Hospital Research Institute | Atlanta | Georgia | 30303 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Swedish Covenant Hospital | Chicago | Illinois | 60625 | — |
| The University of Chicago Medicine Hospital | Chicago | Illinois | 60637 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Massachusetts General Hospital-CAS | Boston | Massachusetts | 02114 | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48910 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| St. Luke's Roosevelt Hospital Center | New York | New York | 10025 | — |
| New York Presbyterian | New York | New York | 10032 | — |
| Rochester General Hospital | Rochester | New York | 14625 | — |
| Forsyth Hospital | Winston-Salem | North Carolina | 27103 | — |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| St. Francis Hospital | Tulsa | Oklahoma | 74136 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| Hospital of the University of PA | Philadelphia | Pennsylvania | 19104 | — |
| Lexington Cardiology | Columbia | South Carolina | 29204 | — |
| Providence Cardiology d/b/a South Caroline Heart Center | Columbia | South Carolina | 29204 | — |
| McLeod Regional Medical Center | Florence | South Carolina | 29506 | — |
| VA North Texas Health Care System | Dallas | Texas | 75216 | — |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | — |
| Plaza Medical Center of Fort Worth | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 94 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01534234, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2019 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01534234 live on ClinicalTrials.gov.