MOre REsponse on Cardiac Resynchronization Therapy With M... | NCT02006069

Label	Type	Description	Intervention Names
MPP ON	Experimental	MPP ON: feature is enabled	Device: MPP
MPP OFF	No Intervention	MPP OFF: feature not enabled

Name	Type	Description	Arm Group Labels	Other Names
MPP	Device	All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").

Measure	Description	Time Frame
Percentage of Non-responder Patients Who Converted to Responders	The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.	Non-responder to responder conversion rate between randomization at 6 months and 12 months

Measure	Description	Time Frame
Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase	Reduction of LVESV between baseline and 6 Months visit	Baseline vs 6 Months
Clinical Composite Score Evaluation	Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below, Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation Unchanged: the patient was neither improved nor worsened

Name	Affiliation	Role
Christophe Leclercq	Centre Cardio-Pneumologique, CHU Pontchaillou	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Research, LLC.		Huntsville	Alabama	35801	United States
Cardiovascular Associates of Mesa

PubMed Identifier	Type	Citation	Retractions
30859220	Derived	Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.
30616009

ID	Title	Description
FG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 9, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Non-responder Patients Who Converted to Responders

The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.

Posted

Count of Participants

Participants

Non-responder to responder conversion rate between randomization at 6 months and 12 months

ID	Title	Description
OG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
OG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.

Units	Counts
Participants	OG000271 OG001555

Title

Denominators

Categories

Title	Measurements
	OG00084 OG001170

Secondary

Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase

Reduction of LVESV between baseline and 6 Months visit

Posted

Mean

Standard Deviation

percentage of LVESV change

Baseline vs 6 Months

ID	Title	Description
OG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
OG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.

Units	Counts
Participants	OG000

Secondary

Clinical Composite Score Evaluation

Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below,

Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation
Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation
Unchanged: the patient was neither improved nor worsened

Posted

Count of Participants

Participants

Baseline vs 12 Months

ID	Title	Description
OG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
OG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.

Secondary

Reverse Left Ventricular (LV) Remodeling

Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months

Only subjects with LVESV data available at both baseline and 12 months were included in this analysis.

Posted

Mean

Standard Deviation

Baseline vs 12 Months

ID	Title	Description
OG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
OG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.

Units	Counts
Participants

Secondary

NYHA Class Changes

Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.

Only subjects with NYHA data available at both baseline and 12 months were included in this analysis.

Posted

Count of Participants

Participants

Baseline vs 12 Months

ID	Title	Description
OG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
OG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.

Units	Counts
Participants

Secondary

6MWT Changes

Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU

Only subjects with 6MHWT data available at both baseline and 12 months were included in this analysis.

Posted

Mean

Standard Deviation

meters

Baseline vs 12 Months

ID	Title	Description
OG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
OG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.

Units	Counts
Participants

Secondary

Patient's QoL Score Changes (MLWHF)

Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).

Only subjects with MLWHF data available at both baseline and 12 months were included in this analysis.

Posted

Mean

Standard Deviation

score on a scale

Baseline vs 12 Months

ID	Title	Description
OG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
OG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.

Units	Counts

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Anticoagulant Overdose	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Hemopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Acute Myocarditis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Aortic Valve Stenosis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Atrial or Ventricular Arrhythmia	Cardiac disorders	Systematic Assessment	EG00028 events23 affected271 at risk EG00160 events42 affected555 at risk
Cardiac Arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Cardiac Tamponade	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Cardiogenic Shock	Cardiac disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0014 events3 affected555 at risk
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Cardiorespiratory Arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Chest Pain	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Coronary Artery Disease	Cardiac disorders	Systematic Assessment	EG0002 events2 affected271 at risk EG0015 events5 affected555 at risk
Dyspnea	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Exacerbation of Heart Failure	Cardiac disorders	Systematic Assessment	EG00040 events30 affected271 at risk EG00176 events53 affected555 at risk
Heart Block	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Mitral Valve Dysfunction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0013 events3 affected555 at risk
Myocardial Infarction	Cardiac disorders	Systematic Assessment	EG0004 events2 affected271 at risk EG0013 events3 affected555 at risk
Pacemaker Mediated Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Pain	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Pericardial Effusion	Cardiac disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events1 affected555 at risk
Pulmonary Edema	Cardiac disorders	Systematic Assessment	EG0005 events4 affected271 at risk EG0018 events7 affected555 at risk
Sudden Cardiac Death	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Valve Damage	Cardiac disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0013 events3 affected555 at risk
Exacerbation of Heart Failure	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Hyperthyroidism Caused by Amiodarone	Endocrine disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Cataract	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Abdominal Affliction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Bleeding/Hematoma/Seroma	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Downhill Varicose and Diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Esophageal Varices	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
GI Bleed	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Gastrointestinal Disease	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected271 at risk EG0012 events2 affected555 at risk
Inguinal Hernia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected271 at risk EG0013 events3 affected555 at risk
Obstipation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Pancreatic Cystic Lesion	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Umbilical Hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Drug Side Effect	General disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Infection	General disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Nausea, Vomiting	General disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Pain	General disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Pain at Pulse Generator Site	General disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Gallbladder Disease	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Hepatitis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Liver Injury	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Drug Allergy	Immune system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Interstitial Pulmonary Fibrosis	Immune system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Infection	Infections and infestations	Systematic Assessment	EG0008 events7 affected271 at risk EG00121 events16 affected555 at risk
Bleeding/Hematoma/Seroma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Bone Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Cardiac Perforation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Coronary Sinus Dissection	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0014 events4 affected555 at risk
Erosion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected271 at risk EG0012 events1 affected555 at risk
Infection	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Mild Concussion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Pain at Pulse Generator Site	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Pericardial Effusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Pneumothorax	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected271 at risk EG0016 events6 affected555 at risk
Pocket Swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Thrombosis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Traumatic Subdural Hemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Diabetes	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Electrolyte Disorder	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Fluid Accumulation	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Obesity	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Gout	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Myogelosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Benign Tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Malignant Tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected271 at risk EG0016 events6 affected555 at risk
Ureteral Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Cerebellar Syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Dementia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Stroke	Nervous system disorders	Systematic Assessment	EG0003 events3 affected271 at risk EG0011 events1 affected555 at risk
Vertigo	Nervous system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Abnormal Lead Pacing Impedance <= 200 OHMS or >=2000 OHMS	Product Issues	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Elevated Pacing Thresholds/Loss of Capture	Product Issues	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)	Product Issues	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Infection	Product Issues	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Lead Dislodgement or Migration	Product Issues	Systematic Assessment	EG0009 events8 affected271 at risk EG00140 events36 affected555 at risk
Lead Fracture	Product Issues	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Oversensing	Product Issues	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Pulse Generator Migration	Product Issues	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Therapy for Non-Ventricular Rhythm	Product Issues	Systematic Assessment	EG0001 events1 affected271 at risk EG0014 events2 affected555 at risk
Undersensing	Product Issues	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Confusion	Psychiatric disorders	Systematic Assessment	EG0002 events1 affected271 at risk EG0010 events0 affected555 at risk
Dementia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Sleep Apnea	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0014 events3 affected555 at risk
Kidney Disease	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected271 at risk EG00112 events11 affected555 at risk
Renal Disease	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Urinary Tract Disease	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Endometriosis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Influenza	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Larynx Perforation After Tee	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Pseudo-Nodular Lung Consolidation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Respiratory Disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Limb Gangrene	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Bone Fracture	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Nose Resection	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Bleeding/Hematoma/Seroma	Vascular disorders	Systematic Assessment	EG0007 events6 affected271 at risk EG0019 events9 affected555 at risk
Bypass Graft Occlusion	Vascular disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Intracardiac Thrombus	Vascular disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Lower Extremity Claudication	Vascular disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Peripheral Artery Disease	Vascular disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0012 events2 affected555 at risk
Syncope	Vascular disorders	Systematic Assessment	EG0002 events2 affected271 at risk EG0011 events1 affected555 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
TIA	Vascular disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Venous Occlusion	Vascular disorders	Systematic Assessment	EG0002 events2 affected271 at risk EG0011 events1 affected555 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Atrial or Ventricular Arrhythmia	Cardiac disorders	Systematic Assessment	EG00029 events24 affected271 at risk EG00143 events41 affected555 at risk
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Coronary Artery Disease	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Dyspnea	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Exacerbation of Heart Failure	Cardiac disorders	Systematic Assessment	EG0007 events5 affected271 at risk EG00113 events13 affected555 at risk
Heart Transplant	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Pacemaker Mediated Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Pulmonary Edema	Cardiac disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Hyperthyreosis	Endocrine disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Chest Pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Mild Diverticulosis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Fever	General disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Pain	General disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0011 events1 affected555 at risk
Pain at Pulse Generator Site	General disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0012 events2 affected555 at risk
Worsening of General Patient's Condition	General disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected271 at risk EG0014 events4 affected555 at risk
Bone Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Coronary Sinus Dissection	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected271 at risk EG0013 events3 affected555 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Tremor	Nervous system disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Bodily Rejection Phenomena	Product Issues	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Elevated Pacing Thresholds/Loss of Capture	Product Issues	Systematic Assessment	EG0006 events5 affected271 at risk EG0019 events8 affected555 at risk
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)	Product Issues	Systematic Assessment	EG00016 events13 affected271 at risk EG00131 events26 affected555 at risk
Lead Dislodgement or Migration	Product Issues	Systematic Assessment	EG0003 events3 affected271 at risk EG0012 events2 affected555 at risk
Oversensing	Product Issues	Systematic Assessment	EG0003 events3 affected271 at risk EG0016 events5 affected555 at risk
Pacemaker Mediated Tachycardia	Product Issues	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Palpitation	Product Issues	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Therapy for Non-Ventricular Rhythm	Product Issues	Systematic Assessment	EG0002 events2 affected271 at risk EG0012 events2 affected555 at risk
Sleep Apnea	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Kidney Disease	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected271 at risk EG0010 events0 affected555 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Respiratory Disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Elective Replacement	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected555 at risk
Bleeding/Hematoma/Seroma	Vascular disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG00110 events10 affected555 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0003 events3 affected271 at risk EG0013 events3 affected555 at risk
Syncope	Vascular disorders	Systematic Assessment	EG0000 events0 affected271 at risk EG0012 events2 affected555 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected555 at risk
Venous Occlusion	Vascular disorders	Systematic Assessment	EG0002 events2 affected271 at risk EG0010 events0 affected555 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
BG001	BiVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MPP ON	MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.	4	271	82	271	67	271
EG001	BIVP	MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.	18	555	190	555	118	555