Trial Outcomes & Findings for Advance Cardiac Resynchronization Therapy (CRT) Registry (NCT NCT01805154)

Last Updated: 2019-08-12

Results Overview

1. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. 2. Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.)

Recruitment status

COMPLETED

Target enrollment

1529 participants

Primary outcome timeframe

6 months

Results posted on

2019-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Cardiac Resynchronization Therapy Patients Patients who have received any market approved St Jude Medical cardiac resynchronization therapy defibrillator (CRT-D) or cardiac resynchronization therapy pacemaker (CRT-P) device. Cardiac resynchronization therapy patients: This is a group of patients who are receiving bi-ventricular pacing therapy from cardiac resynchronization therapy device.
Overall Study STARTED	1529
Overall Study COMPLETED	1175
Overall Study NOT COMPLETED	354

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Information was provided by 1428 subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRT Patients n=1524 Participants Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from a CRT device.
Age, Continuous	67.9 years STANDARD_DEVIATION 11.5 • n=1524 Participants
Sex: Female, Male Female	480 Participants n=1524 Participants
Sex: Female, Male Male	1044 Participants n=1524 Participants
Race/Ethnicity, Customized Race/Ethnic category · American Indian or Alaska Native	6 Participants n=1428 Participants • Information was provided by 1428 subjects
Race/Ethnicity, Customized Race/Ethnic category · Asian	327 Participants n=1428 Participants • Information was provided by 1428 subjects
Race/Ethnicity, Customized Race/Ethnic category · Black or African American	78 Participants n=1428 Participants • Information was provided by 1428 subjects
Race/Ethnicity, Customized Race/Ethnic category · Hispanic or Latino	113 Participants n=1428 Participants • Information was provided by 1428 subjects
Race/Ethnicity, Customized Race/Ethnic category · White or Caucasian	883 Participants n=1428 Participants • Information was provided by 1428 subjects
Race/Ethnicity, Customized Race/Ethnic category · Other	21 Participants n=1428 Participants • Information was provided by 1428 subjects
Region of Enrollment Colombia	27 participants n=1524 Participants
Region of Enrollment Argentina	9 participants n=1524 Participants
Region of Enrollment United States	1147 participants n=1524 Participants
Region of Enrollment India	205 participants n=1524 Participants
New York Heart Association (NYHA) Class NYHA Class I	45 Participants n=1522 Participants • information was available on 1522 subjects
New York Heart Association (NYHA) Class NYHA Class II	335 Participants n=1522 Participants • information was available on 1522 subjects
New York Heart Association (NYHA) Class NYHA Class III	1033 Participants n=1522 Participants • information was available on 1522 subjects
New York Heart Association (NYHA) Class NYHA Class IV	109 Participants n=1522 Participants • information was available on 1522 subjects
Type of Cardiomyopathy Ischemic	597 Participants n=1518 Participants • Information was available on 1518 subjects
Type of Cardiomyopathy Non-Ischemic	709 Participants n=1518 Participants • Information was available on 1518 subjects
Type of Cardiomyopathy None	212 Participants n=1518 Participants • Information was available on 1518 subjects
Left Ventricular Ejection Fraction % (EF)	29.2 Percent blood ejected STANDARD_DEVIATION 11.2 • n=1521 Participants • Information was available on 1521 subjects
History of Atrial Fibrillation (AF)	583 Participants n=1518 Participants • Information was available on 1518 subjects

PRIMARY outcome

Timeframe: 6 months

Population: The analysis population included any subject who had a 6-month CRT evaluation or died due to a cardiovascular cause prior to 6 months. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.

Outcome measures

Outcome measures
Measure	CRT Patients n=1327 Participants Patients who received any market approved St. Jude Medical CRT-D or CRT-P device.	Site CRT Non-Responders Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT non-responders at 6 months.
Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response Site Determined CRT Response	1061 Participants	—
Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response CCS Deteremined CRT Response	900 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: The analysis population included any subject with a completed 6-month CRT evaluation. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.

Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.

Outcome measures

Outcome measures
Measure	CRT Patients n=1299 Participants Patients who received any market approved St. Jude Medical CRT-D or CRT-P device.	Site CRT Non-Responders Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT non-responders at 6 months.
Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT Echocardiographic Remodeling Used	431 Participants	—
Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT Clinical Functional Assessment Used	847 Participants	—
Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT Clinical Events Used	858 Participants	—

PRIMARY outcome

Timeframe: Between 6 and 12 months

Outcome measures

Outcome measures
Measure	CRT Patients n=1299 Participants Patients who received any market approved St. Jude Medical CRT-D or CRT-P device.	Site CRT Non-Responders Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT non-responders at 6 months.
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Device LV Pacing Change	63 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Device AV/VV Intervals Optimized	197 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Other Device Parameters Changed	88 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Medication Changed	319 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Arrythmia Treatments	79 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Diet Compliance	53 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Medication Compliance	42 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months HF Education Provided	328 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Other Treatments	71 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Treatment for Comorbidities	100 Participants	—
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months Bi-Ventricular Pacing Increase	43 Participants	—

PRIMARY outcome

Timeframe: Between 6 and 12 months

Population: Only subjects who had evaluable data at 6 and 12 months are included. Thus, fewer subjects than those who completed the 6-month and 12-month visits were analyzable.

Improvement in NYHA Class determined by improvement by at least 1 class.

Outcome measures

Outcome measures
Measure	CRT Patients n=559 Participants Patients who received any market approved St. Jude Medical CRT-D or CRT-P device.	Site CRT Non-Responders n=90 Participants Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT non-responders at 6 months.
Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months	93 Participants	34 Participants

Adverse Events

CRT Patients

Serious events: 226 serious events

Other events: 403 other events

Deaths: 132 deaths

Serious adverse events

Serious adverse events
Measure	CRT Patients n=1524 participants at risk Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device. Of 1529 subjects enrolled, 5 were not included in analysis (1 had incomplete informed consent and 4 did not receive a device implant).
Cardiac disorders Acute CHF	4.6% 70/1524 • Number of events 102 • Data were collected and reported over the 12-month study period.
Cardiac disorders Atrial Arrythmia	0.79% 12/1524 • Number of events 14 • Data were collected and reported over the 12-month study period.
Cardiac disorders Atrial Fib Ablation	0.20% 3/1524 • Number of events 3 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications Air Embolism	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications Arrest Cardiopulmonary	0.26% 4/1524 • Number of events 4 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications BLEEDING(NON-HEMATOMA)	0.46% 7/1524 • Number of events 7 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications CARDIAC TAMPONADE	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications CARDIAC/CORONARY SINUS DISSECTION	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders CHEST PAIN	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications ER VISIT AND OBSERVATION ADMISSION	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Infections and infestations EROSION/EXTRUSION	0.20% 3/1524 • Number of events 3 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications HEMATOMA	0.39% 6/1524 • Number of events 7 • Data were collected and reported over the 12-month study period.
General disorders HOSPITALIZATION FOR DECREASED MENTAL STATUS AND FEVER	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Infections and infestations INFECTION	0.46% 7/1524 • Number of events 7 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications LEAD DISLODGEMENT OR MIGRATION	2.7% 41/1524 • Number of events 51 • Data were collected and reported over the 12-month study period.
Product Issues RA LEAD FRACTURE	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Product Issues RV LEAD MALFUNCTION	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Product Issues LV LOSS OF CAPTURE	0.13% 2/1524 • Number of events 3 • Data were collected and reported over the 12-month study period.
Cardiac disorders MYOCARDIAL INFARCTION	1.2% 19/1524 • Number of events 20 • Data were collected and reported over the 12-month study period.
Cardiac disorders NEW OR WORSENED ANGINA	0.26% 4/1524 • Number of events 4 • Data were collected and reported over the 12-month study period.
Cardiac disorders OTHER Cardiac	0.52% 8/1524 • Number of events 10 • Data were collected and reported over the 12-month study period.
Cardiac disorders OTHER Death	0.33% 5/1524 • Number of events 5 • Data were collected and reported over the 12-month study period.
Gastrointestinal disorders OTHER Gastro	0.39% 6/1524 • Number of events 6 • Data were collected and reported over the 12-month study period.
General disorders OTHER General	2.4% 37/1524 • Number of events 43 • Data were collected and reported over the 12-month study period.
Infections and infestations OTHER Infections	0.92% 14/1524 • Number of events 17 • Data were collected and reported over the 12-month study period.
Respiratory, thoracic and mediastinal disorders Other Respiratory	0.46% 7/1524 • Number of events 11 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications PERICARDIAL EFFUSION	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications PHRENIC NERVE/DIAPHRAGMATIC STIMULATION	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications PNEUMOTHORAX	0.20% 3/1524 • Number of events 3 • Data were collected and reported over the 12-month study period.
General disorders SOB; EDEMA; DIURESIS; MONITORING	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Product Issues PULSE GENERATOR MALFUNCTION	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications SHOCK/HYPOTENSION	0.33% 5/1524 • Number of events 6 • Data were collected and reported over the 12-month study period.
General disorders SYNCOPE UNKNOWN ETIOLOGY	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
General disorders THROMBO-EMBOLIC EVENT	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Musculoskeletal and connective tissue disorders TRIMALLEOLAR FRACTURE RIGHT ANKLE	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.72% 11/1524 • Number of events 11 • Data were collected and reported over the 12-month study period.
Cardiac disorders WORSENING CAD	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.

Other adverse events

Other adverse events
Measure	CRT Patients n=1524 participants at risk Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device. Of 1529 subjects enrolled, 5 were not included in analysis (1 had incomplete informed consent and 4 did not receive a device implant).
Cardiac disorders ACUTE CORONARY SYNDROME	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders ARREST - CARDIOPULMONARY	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Cardiac disorders ASYSTOLE	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders ATRIAL ARRHYTHMIA	2.4% 37/1524 • Number of events 39 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications BLEEDING(NON-HEMATOMA)	0.46% 7/1524 • Number of events 7 • Data were collected and reported over the 12-month study period.
General disorders CHEST PAIN	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Gastrointestinal disorders CLOSTRIDIUM DIAARHEA	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Gastrointestinal disorders CONSTIPATION	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders DECOMPENSATED HF	6.4% 98/1524 • Number of events 133 • Data were collected and reported over the 12-month study period.
General disorders DIZZINESS, NAUSEA, IRREGULAR HEART BEAT	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Product Issues ELEVATED PACING THRESHOLDS	0.92% 14/1524 • Number of events 14 • Data were collected and reported over the 12-month study period.
General disorders FATIGUE	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders HEART FAILURE	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications HEMATOMA	1.1% 17/1524 • Number of events 18 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications HEMOTHORAX	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Product Issues HIGH DFT'S	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Infections and infestations INFECTION	1.6% 25/1524 • Number of events 26 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications LEAD DISLODGEMENT OR MIGRATION	0.33% 5/1524 • Number of events 5 • Data were collected and reported over the 12-month study period.
Product Issues Lead Noise	0.20% 3/1524 • Number of events 3 • Data were collected and reported over the 12-month study period.
Product Issues LOSS OF CAPTURE	0.39% 6/1524 • Number of events 7 • Data were collected and reported over the 12-month study period.
Product Issues LOSS OF SENSING	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Cardiac disorders LOW CARDIAC OUTPUT SYNDROME AND PULMONARY OEDEMA	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Vascular disorders LOWER EXTREMITY EDEMA	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders MYOCARDIAL INFARCTION	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders NEW OR WORSENED ANGINA	0.46% 7/1524 • Number of events 7 • Data were collected and reported over the 12-month study period.
Cardiac disorders OTHER Cardiac	1.2% 18/1524 • Number of events 20 • Data were collected and reported over the 12-month study period.
Gastrointestinal disorders OTHER Gastro	1.7% 26/1524 • Number of events 26 • Data were collected and reported over the 12-month study period.
General disorders OTHER General	11.4% 174/1524 • Number of events 284 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications OTHER Implant	0.79% 12/1524 • Number of events 12 • Data were collected and reported over the 12-month study period.
Infections and infestations OTHER Infections	2.4% 37/1524 • Number of events 53 • Data were collected and reported over the 12-month study period.
Respiratory, thoracic and mediastinal disorders Other Respiratory	1.2% 18/1524 • Number of events 23 • Data were collected and reported over the 12-month study period.
Product Issues OVERSENSING	0.59% 9/1524 • Number of events 10 • Data were collected and reported over the 12-month study period.
Product Issues OVERSENSING RESULTING IN THERAPY	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Product Issues PACEMAKER MEDIATED TACHYCARDIA (PMT)	0.33% 5/1524 • Number of events 5 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications PERICARDIAL EFFUSION	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Product Issues PHRENIC NERVE/DIAPHRAGMATIC STIMULATION	2.2% 33/1524 • Number of events 38 • Data were collected and reported over the 12-month study period.
Injury, poisoning and procedural complications PNEUMOTHORAX	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Infections and infestations SHOCK/HYPOTENSION	0.33% 5/1524 • Number of events 5 • Data were collected and reported over the 12-month study period.
General disorders SYNCOPE UNKNOWN ETIOLOGY	0.46% 7/1524 • Number of events 7 • Data were collected and reported over the 12-month study period.
Cardiac disorders THERAPY FOR NON-VENTRICULAR RHYTHM	0.59% 9/1524 • Number of events 13 • Data were collected and reported over the 12-month study period.
General disorders THROMBO-EMBOLIC EVENT	0.39% 6/1524 • Number of events 6 • Data were collected and reported over the 12-month study period.
Product Issues UNDERSENSING	0.13% 2/1524 • Number of events 2 • Data were collected and reported over the 12-month study period.
Infections and infestations UPPER RESIRATORY TRACT INFECTION	0.07% 1/1524 • Number of events 1 • Data were collected and reported over the 12-month study period.
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.46% 7/1524 • Number of events 51 • Data were collected and reported over the 12-month study period.

Additional Information

Clay Cohorn, Clinical Program Director

Abbott

Phone: 972-309-8087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60